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Tratamiento conservador para la incontinencia urinaria posterior a la prostatectomía

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Referencias

Ahmed 2012 {published data only}

Ahmed MT, Mohammed AH, Amansour A. Effect of pelvic floor electrical stimulation and biofeedback on the recovery of urinary continence after radical prostatectomy. Turkiye Fiziksel Tip ve Rehabilitasyon Dergisi 2012;58(3):170‐6. [sr‐incont47262]
Omar M, Mohammed AH. Effect of pelvic floor exercises, electrical stimulation and biofeedback on urinary incontinence after radical prostatectomy: single blind randomized clinical trial. ANZCTR (http://www.anzctr.org.au/ACTRN12610000975099.aspx)2010.

Bales 2000 {published data only}

Bales G, Gerber G, Minor T, Mhoon D, McFarland J, Hyung L, et al. Effect of preoperative biofeedback/pelvic floor training on continence in men undergoing radical prostatectomy. Urology 2000;56:627‐30. [SRINCONT11831]

Burgio 2006 {published and unpublished data}

Burgio KL, Goode P, Urban D. Umlauf M, Locher J, Bueschen A, Redden D. Preoperative biofeedback‐assisted behavioural training to reduce post‐prostatectomy incontinence: A randomized controlled trial. Journal of Urology 2006;175(1):196‐201. [SRINCONT21637]
Burgio KL, Goode P, Urban D. Umlauf M, Locher J, Bueschen A, Redden D. Preoperative biofeedback‐assisted behavioural training to reduce post‐prostatectomy incontinence: A randomized controlled trial [abstract]. Neurourology and Urodynamics 2005;24(5/6):477. [SRINCONT20970]

Centemero 2009 {published data only}

Centemero A, Rigatti L, Andrea L, Gallina A, Lughezzani G, Montorsi F, et al. Effectiveness of pre‐operative pelvic floor muscle training for post‐prostatectomy early incontinence recovery (Abstract number 1642). Journal of Urology 2009;181(4 (Suppl 1)):591. [SR‐INCONT34592]
Centemero A, Rigatti L, Giraudo D, Lazzeri M, Lughezzani G, Zugna D, et al. Preoperative pelvic floor muscle exercise for early continence after radical prostatectomy: a randomised controlled study. European Urology 2010;57(6):1039‐43. [SR‐INCONT40316]

Dijkstra‐Eshuis 2013 {published data only}

Dijkstra‐Eshuis J, Splinter R, Zonneveld W, Putter H, Van Den Bos T, Bevers R, et al. Effect of preoperative pelvic floor muscle therapy with biofeedback versus standard care on stress urinary incontinence and quality of life in men undergoing laparoscopic radical prostatectomy (Abstract number 137). Neurourology and Urodynamics 2013;32(6):712‐3. [sr‐incont49210]
Dijkstra‐Eshuis J, van den Bos TW, Splinter R, Bevers RF, Zonneveld WC, Putter H, et al. Effect of preoperative pelvic floor muscle therapy with biofeedback versus standard care on stress urinary incontinence and quality of life in men undergoing laparoscopic radical prostatectomy: A randomised control trial [epub ahead of print published online 19 November 2013]. Neurourology and Urodynamics2013. [sr‐incont49547]
Voorham‐Van Der Zalm P, Dijkstra‐Eshuis J, Splinter R, Putter H, Bevers RFM, Pelger RCM. Effect of preoperative pelvic floor muscle therapy versus standard care on stress urinary incontinence in men undergoing radical laparoscopic prostatectomy (Abstract number 1365). Journal of Urology 2013;189(4 Suppl 1):e558‐9. [sr‐incont50002]
Voorham‐Van Der Zalm PJ, Stoetman AM, Putter H, Bevers RFM, Pelger RCM. Effect of preoperative pelvic floor physiotherapy versus standard care on incontinence in men undergoing radical laparoscopic prostatectomy: an ongoing study (Abstract number 590). Proceedings of the Joint Meeting of the International Continence Society (ICS) and the International Urogynecological Association, 2010 Aug 23‐27, Toronto, Canada. 2010. [SR‐INCONT40184]

Dubbelman 2004 {published and unpublished data}

Dubbelman Y, Groen J, Wildhagen M, Rikken B, Bosch R. The recovery of urinary continence after radical retropubic prostatectomy: a randomized trial comparing the effect of physiotherapist‐guided pelvic floor muscle exercises with guidance by an instruction folder only. BJU International 2010;106(4):515‐22. [SR‐INCONT40056]
Dubbelman Y, Groen J, Wildhagen M, Rikken B, Bosch R. UPDATE Quantification of changes in detrusor function and pressure‐flow parameters after radical prostatectomy: relation to postoperative continence status and the impact of intensity of pelvic floor muscle exercises. Neurourology and Urodynamics 2012;31(5):637‐41. [srincont45959]
Dubbelman YD, Groen J, Bosch R. Post prostatectomy incontinence: Significance of the pre‐operative urethral pressure profile and the role of physiotherapy [abstract]. Neurourology and Urodynamics 2004;23(5‐6):471. [SRINCONT19009]
Dubbelman YD, Groen J, Wildhagen MF, Rikken B, Bosch JL. UPDATE Urodynamic quantification of decrease in sphincter function after radical prostatectomy: relation to postoperative continence status and the effect of intensive pelvic floor muscle exercises. Neurourology and Urodynamics 2012;31(5):646‐51. [srincont45958]

Fader 2013 {published data only}

Fader M, Macaulay M, Broadbridge J, Cottenden A, Birch B, Moore KN. A trial of devices for the management of urinary incontinence following treatment for prostate cancer (Abstract number 264). Neurourology and Urodynamics 2013;32(6):891‐2. [sr‐incont49194]

Filocamo 2005 {published and unpublished data}

Del Popolo G, Filocamo MT, Li Marzi V, Cecconi F, Marzocco M, Tosto A, et al. Effectiveness of early pelvic floor rehabilitation treatment for post‐prostatectomy incontinence (Abstract number 610). Proceedings of the International Continence Society (ICS), 35th Annual Meeting, 2005 Aug 28‐Sep 2, Montreal, Canada2005. [SR‐INCONT21063]
Filocamo MT, Li Marzi V, Del Popolo G, Cecconi F, Marzocco M, Tosto A, et al. Effectiveness of early pelvic floor rehabilitation treatment for post‐prostatectomy incontinence. European Urology 2005;48(5):734‐8. [SRINCONT21252]

Floratos 2002 {published data only}

Foratos DL, Sonke GS, Rapidou CA, Alivizatos GJ, Deliveliotis C, Constantinides CA, et al. Biofeedback versus verbal feedback as learning tools for pelvic muscle exercises in the early management of urinary incontinence after radical prostatectomy. British Journal of Urology International 2002;89(7):714‐9. [SRINCONT15333]

Fode 2014 {published data only}

Fode M, Borre M, Ohl DA, Lichtbach J, Sonksen J. Penile vibratory stimulation in the recovery of urinary continence and erectile function after nerve‐sparing radical prostatectomy: a randomized, controlled trial [epub ahead of print] [first published online 22 Jan 2014]. BJU International2014. [NCT01067261; sr‐incont50324]
Sonksen JR. Transcutaneous Mechanical Nerve Stimulation (TMNS) by Vibration in the Preservation and Restoration of Urinary Continence and Erectile Function and in the Treatment of Erectile Dysfunction and Urinary Incontinence in Conjunction With Nerve Sparing Radical Prostatectomy. http://clinicaltrials.gov/show/NCT010672612010. [NCT01067261; sr‐incont47825]

Franke 1998 {published data only}

Franke JJ, Gilbert WB, Grier J, Koch MO, Shyr Y, Smith JA. Early post‐prostatectomy pelvic floor biofeedback. Journal of Urology 2000;163(1):191‐3. [SRINCONT9180]
Franke JJ, Grier J, Koch MO, Smith JA. Biofeedback‐enhanced pelvic floor exercises in the early post prostatectomy period. Journal of Urology 1998;159 Suppl 5:37. [SRINCONT5734]

Geraerts 2013 {published data only}

Geraerts I, van Poppel H, Devoogdt N, Joniau S, van Cleynenbreugel B, De Groef A, et al. Influence of preoperative and postoperative pelvic floor muscle training (PFMT) compared with postoperative PFMT on urinary incontinence after radical prostatectomy: a randomized controlled trial. European Urology 2013;64(5):766‐72. [NTR1953; sr‐incont49488]

Ghanem 2013 {published data only}

Ghanem A, Khallaf M, Assem A, Hassan A. Does preoperative pelvic floor muscle exercise improve post prostatectomy urinary incontinence? (Abstract number 695). Proceedings of the 43rd Annual Meeting of the International Continence Society (ICS), 2013 Aug 26‐30, Barcelona, Spain2013. [sr‐incont49728]

Glazener RP 2011 {published data only}

Dorey G, Glazener C, Buckley B, Cochran C, Moore K. Developing a pelvic floor muscle training regimen for use in a trial intervention. Physiotherapy 2009;95(3):199‐209. [SR‐INCONT32096]
Glazener C, Boachie C, Buckley B, Cochran C, Dorey G, Grant A, et al. A randomized controlled trial of conservative treatment (pelvic floor muscle training and bladder training) for urinary incontinence in men after prostate surgery (MAPS) (Abstract number 200). Neurourology and Urodynamics 2010;29(6):1093‐4. [SR‐INCONT40156]
Glazener C, Boachie C, Buckley B, Cochran C, Dorey G, Grant A, et al. Conservative treatment for urinary incontinence in Men After Prostate Surgery (MAPS): two parallel randomised controlled trials. Health Technology Assessment (Winchester, England) 2011;15(24):1‐290. [SR‐INCONT41754]
Glazener C, Boachie C, Buckley B, Cochran C, Dorey G, Grant A, et al. Urinary incontinence in men after formal one‐to‐one pelvic‐floor muscle training following radical prostatectomy or transurethral resection of the prostate (MAPS): two parallel randomised controlled trials. Lancet 2011;378(9788):328‐37. [SR‐INCONT41752]
Glazener CMA. MAPS (Men After Prostate Surgery): Conservative Treatment for Men With Urinary Incontinence After Prostate Surgery; Multicentre Randomised Controlled Trial of Pelvic Floor Muscle Training and Biofeedback [MAPS]. http://clinicaltrials.gov/show/NCT006321382005. [NCT00632138; sr‐incont47844]
Hagen S, Glazener C, Cochran C, Campbell L. Continence care for men having prostate surgery: advice and care before and after radical prostatectomy and transurethral resection of prostate (Abstract number 96). Neurourology and Urodynamics 2009;28(7):690‐1. [SRINCONT34583]
Update Buckley B, Lapitan MCM, Glazener C. The effect of urinary incontinence on health utility and health related quality of life in men following prostate surgery (Abstract number 542). Proceedings of the 41st Annual Meeting of the International Continence Society (ICS), 2011 Aug 29 to Sept 2, Glasgow, Scotland2011. [ISRCTN87696430; MAPS; srincont47758]
Update Buckley BS, Lapitan MC, Glazener CM, MAPS Trial Group. The effect of urinary incontinence on health utility and health‐related quality of life in men following prostate surgery. Neurourology and Urodynamics 2012;31(4):465‐9. [ISRCTN87696430; MAPS; NCT00632138; srincont44658]
Update Glazener C, Boachie C, Hagen S, Kilonzo M, Cochran C, Buckley B, et al. Clinical outcomes two years after a randomised controlled trial of pelvic floor muscle training after radical prostatectomy or TURP: men after prostate surgery trial (MAPS) (Abstract number 254). Neurourology and Urodynamics 2011;30(6):1150‐1. [MAPS; srincont:42203]

Glazener TURP 2011 {published data only}

Dorey G, Glazener C, Buckley B, Cochran C, Moore K. Developing a pelvic floor muscle training regimen for use in a trial intervention. Physiotherapy 2009;95(3):199‐209.
Glazener C, Boachie C, Buckley B, Cochran C, Dorey G, Grant A, et al. A randomized controlled trial of conservative treatment (pelvic floor muscle training and bladder training) for urinary incontinence in men after prostate surgery (MAPS) (Abstract number 200). Neurourology and Urodynamics 2010;29(6):1093‐4.
Glazener C, Boachie C, Buckley B, Cochran C, Dorey G, Grant A, et al. Conservative treatment for urinary incontinence in Men After Prostate Surgery (MAPS): two parallel randomised controlled trials. Health Technology Assessment (Winchester, England) 2011;15(24):1‐290.
Glazener C, Boachie C, Buckley B, Cochran C, Dorey G, Grant A, et al. Urinary incontinence in men after formal one‐to‐one pelvic‐floor muscle training following radical prostatectomy or transurethral resection of the prostate (MAPS): two parallel randomised controlled trials. Lancet 2011;378(9788):328‐37.
Hagen S, Glazener C, Cochran C, Campbell L. Continence care for men having prostate surgery: advice and care before and after radical prostatectomy and transurethral resection of prostate (Abstract number 96). Neurourology and Urodynamics 2009;28(7):690‐1.
Update Buckley B, Lapitan MCM, Glazener C. The effect of urinary incontinence on health utility and health related quality of life in men following prostate surgery (Abstract number 542). Proceedings of the 41st Annual Meeting of the International Continence Society (ICS), 2011 Aug 29 to Sept 2, Glasgow, Scotland2011. [ISRCTN87696430; MAPS; srincont47758]
Update Buckley BS, Lapitan MC, Glazener CM, MAPS Trial Group. The effect of urinary incontinence on health utility and health‐related quality of life in men following prostate surgery. Neurourology and Urodynamics 2012;31(4):465‐9. [ISRCTN87696430; MAPS; NCT00632138; srincont44658]
Update Glazener C, Boachie C, Hagen S, Kilonzo M, Cochran C, Buckley B, et al. Clinical outcomes two years after a randomised controlled trial of pelvic floor muscle training after radical prostatectomy or TURP: men after prostate surgery trial (MAPS) (Abstract number 254). Neurourology and Urodynamics 2011;30(6):1150‐1. [MAPS; srincont:42203]

Goode 2009 {published data only}

Goode P, Burgio K, Johnson T, Roth D, Clay O, Burkhardt J, et al. Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent post‐prostatectomy incontinence ‐ a randomized controlled trial (Abstract number 87). Neurourology and Urodynamics 2009;28(7):681‐2. [SR‐INCONT34582]
Goode PS. Conservative Treatment of Postprostatectomy Incontinence. http://clinicaltrials.gov/show/NCT002122642003. [NCT00212264; sr‐incont47864]
Goode PS, Burgio KL, Johnson TM, Clay OJ, Roth DL, Markland AD, et al. Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent postprostatectomy incontinence: a randomized controlled trial. JAMA 2011;305(2):151‐9. [SR‐INCONT40806]

Hoffman 2005 {published and unpublished data}

Hoffmann W, Liedke S, Dombo O, Otto U. Electrical stimulation to treat postoperative incontinence: Therapeutic benefit in regard to quality of life [Die Electrostimulation in der Therapie der posopertiven Harninkontinenz. Therapeutischer Nutzen unter Berucksichtigung der Lebensqualitat]. Urologe 2004;44:33‐40. [SRINCONT20402]

Hou 2013 {published data only}

Hou CP, Chen TY, Chang CC, Lin YH, Chang PL, Chen CL, et al. Use of the SF‐36 quality of life scale to assess the effect of pelvic floor muscle exercise on aging males who received transurethral prostate surgery. Clinical Interventions In Aging 2013;8:667‐73. [sr‐incont48064]

Joseph 2000 {published and unpublished data}

Joseph AC, Chang MK. Comparison of behavior therapy methods for urinary incontinence following prostate surgery: a pilot study. Urologic Nursing 2000;20(3):203‐4. [SRINCONT15334]

Koo 2009 {published data only}

Kim YH, Hwang EG, Shin JH, Kim YW, Lim JS, Na YG, Song KH, Sul CK. Effect of extracorporeal magnetic innervation (ExMI) pelvic floor therapy for urinary incontinence after radical prostatectomy. Urology 2009;74 Suppl 4A:S227. [SR‐INCONT42741]
Koo D, So SM, Lim JS. Effect of Extracorporeal Magnetic Innervation (ExMI) pelvic floor therapy on urinary incontinence after radical prostatectomy [Korean]. Korean Journal of Urology 2009;50(1):23‐7. [SR‐INCONT34595]

Laurienzo 2013 {published data only}

Laurienzo CE, Sacomani CA, Rodrigues TR, Zequi Sde C, Guimaraes GC, Lopes A. Results of preoperative electrical stimulation of pelvic floor muscles in the continence status following radical retropubic prostatectomy. International Brazilian Journal of Urology 2013;39(2):182‐8. [sr‐incont48139]

Liu 2008 {published data only}

Liu F. [Extracorporeal magnetic innervation in the treatment of urinary incontinence after radical prostatectomy]. Journal of Clinical Rehabilitative Tissue Engineering Research 2008;12(17):3289‐92. [SRINCONT34489]

Manassero 2007 {published data only}

Manassero F, Traversi C, Ales V, Pistolesi D, Panicucci E, Valent F, et al. Contribution of early intensive prolonged pelvic floor exercises on urinary continence recovery after bladder neck‐sparing radical prostatectomy: results of a prospective controlled randomized trial. Neurourology and Urodynamics 2007;26(7):985‐9. [SRINCONT23915]

Marchiori 2010 {published data only}

Marchiori D, Bertaccini A, Manferrari F, Ferri C, Martorana G. Pelvic floor rehabilitation for continence recovery after radical prostatectomy: role of a personal training re‐educational program. Anticancer Research 2010;30(2):553‐6.

Mariotti 2009 {published data only}

Mariotti G, Sciarra A, Gentilucci A, Salciccia S, Alfarone A, Pierro GD, et al. Early recovery of urinary continence after radical prostatectomy using early pelvic floor electrical stimulation and biofeedback associated treatment. Journal of Urology 2009;181(4):1788‐93. [SRINCONT31079]
Sciarra A, Salciccia S, Gentilucci A, Alfarone A, Di Pierro GB, Mariotti G, et al. Early recovery of urinary continence after radical prostatectomy using early pelvic floor electric stimulation and biofeedback associated treatment. Journal of Urology 2009;181(4 Suppl 1):680. [SRINCONT42739]
Sciarra A, Salciccia S, Gentilucci A, Alfarone A, Mariotti G, Cattarino S, et al. Early recovery of urinary continence after radical prostatectomy using early pelvic floor electric stimulation and biofeedback associated treatment (Abstract number 412). European Urology Supplements 2009;8(4):223. [SR‐INCONT42738]

Martini 2011 {published data only}

Martini M, Bernardini S, Blanc E, Piretta K, Tappero R. Relationship between integrity of pelvic floor function and recovery of continence after laparoscopic prostatectomy and effects of preventive pelvic floor training in males with pelvic floor weakness (Abstract number 14). Neurourology and Urodynamics 2011;30 Suppl 1:11‐2. [sr‐incont47398]

Mathewson‐Chapman 97 {published data only}

Mathewson‐Chapman M. The effect of pelvic muscle exercises with biofeedback for urinary incontinence post‐prostatectomy. [Unpublished PhD dissertation]. Gainsville: University of Florida, 1995. [SRINCONT11221]
Mathewson‐Chapman M. Pelvic muscle exercise/biofeedback for urinary incontinence after prostatectomy: an education program. Journal of Cancer Education 1997;12(4):218‐23. [SRINCONT5381]

Moore 1999 {published and unpublished data}

Moore KN. The effect of urinary incontinence on the quality of life following radical prostatectomy [Unpublished PhD Thesis]. Edmonton: University of Alberta, 1997. [SRINCONT8006]
Moore KN, Griffiths DJ, Hughton A. A randomised controlled trial of pelvic muscle exercises or pelvic muscle exercises plus electrical stimulation for post radical prostatectomy urinary incontinence [abstract]. Neurourology and Urodynamics 1998;17:424‐6. [SRINCONT5677]
Moore KN, Griffiths DJ, Hughton A. Urinary incontinence after post radical prostatectomy: A randomised controlled trial comparing pelvic muscle exercises with pelvic muscle exercises plus electrical stimulation. British Journal of Urology International 1999;83:57‐65. [SRINCONT5730]

Moore 2004 {published data only}

Moore KN, Schieman S, Ackerman T, Drus H, Metcalfe JB, Voaklander DC. Assessing the comfort, safety and patient satisfaction with three commonly used penile compression devices. Urology 2004;63(1):150‐4. [SRINCONT19156]

Moore 2008 {published and unpublished data}

Moore KN. The effectiveness of biofeedback assisted pelvic floor muscle exercises in the treatment of incontinence post radical prostatectomy. [Personal Communication] (as supplied 11 May 2006). Data on file.
Moore KN, Valiquette L, Chetner MP, Byrniak S, Herbison GP. Return to continence after radical retropubic prostatectomy: A randomized trial of verbal and written instructions versus therapist‐directed pelvic floor muscle therapy. Urology 2008;72(6):1280‐6. [SR‐INCONT26907]

Morihiro 2011 {published data only}

Morihiro N, Masatsugu I, Shinji K, Kenichi T, Kazumasa M, Shiro B. Effectiveness of sacral surface therapeutic electrical stimulation (SSTES) on early recovery of urinary incontinence after laparoscopic radical prostatectomy: a prospective study (Abstract number 64). Neurourology and Urodynamics 2011;30(6):889‐90. [SR‐INCONT42173]

Nowak 2007 {published data only}

Nowak M, Jordan M, Haberl S, Herwig R, Kuehhas F, Brausi M, et al. Prospective study of extracorporeal magnetic innervation pelvic floor therapy (EXMI) versus standard pelvic floor training following radical prostatectomy: Impact on timing and magnitude of recovery of continence (Abstract number 482). European Urology Supplements 2007;6(2):143. [SRINCONT34792]

Opsomer 1994 {published data only}

Opsomer RJ, Castille Y, Abi Aad AS, van Cangh PJ. Urinary incontinence after radical prostatectomy: Is professional pelvic floor training necessary?. Neurourology and Urodynamics 1994;13(4):382‐4. [SRINCONT2687]

Overgard 2008 {published data only}

Morkved S. Urinary Incontinence After Radical Prostatectomy. ‐ Effect of Pelvic Floor Muscle Training. A Randomised Controlled Trial. http://clinicaltrials.gov/show/NCT002398242005. [NCT00239824; sr‐incont47830]
Morkved S, Overgard M, Lydersen S, Angelsen A. Does pelvic floor muscle training with follow up instructions by a physiotherapist reduce urinary incontinence after radical prostatectomy? ‐ A randomised controlled trial (Abstract number 15). Neurourology and Urodynamics 2008;27(7):587‐8. [SR‐INCONT31841]
Overgard M, Angelsen A, Lydersen S, Morkved S. Does physiotherapist‐guided pelvic floor muscle training reduce urinary incontinence after radical prostatectomy?: A randomised controlled trial. European Urology 2008;54:438‐48. [SR‐INCONT26906]
Update Angelsen A, Nilssen S, Overgard M, Lydersen S, Morkved S. Does physiotherapist‐guided pelvic floor muscle training increase the quality of life in patients after radical prostatectomy? A randomized clinical study (Abstract number 733). Proceedings of the 42nd Annual Meeting of the International Continence (ICS), 2012 Oct 15 to 19, Beijing, China2012. [NCT00239824; srincont47938]
Update Nilssen SR, Morkved S, Overgard M, Lydersen S, Angelsen A. Does physiotherapist‐guided pelvic floor muscle training increase the quality of life in patients after radical prostatectomy? A randomized clinical study. Scandinavian Journal of Urology and Nephrology 2012;46(6):397‐404. [NCT00239824; SR‐INCONT46190]

Parekh 2003 {published data only}

Parekh AR, Feng Mi, Kirages D, Bremner H, Kaswick J, Aboseif S. The role of pelvic floor exercises on post‐prostatectomy incontinence. Journal of Urology 2003;170:130‐3. [SRINCONT16004]

Park 2012 {published data only}

Park S‐W, Park C‐S, Kim T‐N, Lee W, Nam J‐K. The effects of a 12‐week's combined exercise intervention on physical function and mental health after radical prostatectomy in elderly patients with prostate cancer: a prospective, randomised controlled study (Abstract number 1309). Journal of Urology 2011;185(4S):e524. [SR‐INCONT42511]
Park SW, Kim TN, Nam JK, Ha HK, Shin DG, Lee W, et al. Recovery of overall exercise ability, quality of life, and continence after 12‐week combined exercise intervention in elderly patients who underwent radical prostatectomy: a randomized controlled study. Urology 2012;80(2):299‐306. [SR‐INCONT45132]

Perissinotto 2008 {published data only}

Perissinotto MCR, D'Ancona CAL, Campos RM, Lucio AC, Silva JrW. Physiotherapeutic for treatment of post radical prostatectomy urinary incontinence (Abstract number 265). Proceedings of the International Continence Society (ICS), 38th Annual Meeting, 2008 Oct 20‐24, Cairo, Egypt. 2008. [SRINCONT31843]

Porru 2001 {published data only}

Porru D, Campus G, Caria A, Madeddu, Cucchi A, Rovereto B, et al. Impact of early pelvic floor rehabilitation after transurethral resection of the prostate. Neurourology and Urodynamics 2001;20:53‐9. [SRINCONT11849]

Ribeiro 2008 {published data only}

Ribeiro LH, Prota C, Gomes CM, de Bessa J, Boldarine MP, Dall'Oglio MF, et al. Long‐term effect of early postoperative pelvic floor biofeedback on continence in men undergoing radical prostatectomy: a prospective, randomized, controlled trial. Journal of Urology 2010;184(3):1034‐9. [SR‐INCONT40040]
Ribeiro LS, Prota C, Gomes CM, Dall'Oglio MF, Bruschini H, Srougi M. Effect of early postoperative pelvic‐floor biofeedback on continence in men undergoing radical prostatectomy: A randomized, controlled trial (Abstract number 1412). Journal of Urology 2008;179(4 Suppl S):483. [SRINCONT26921]
Ribiero LS, Prota C, Gomes CM, Boldarine MP, Nakano E, Dall'Oglio M, et al. Early pelvic‐floor biofeedback training promotes long‐term improvement of urinary continence after radical prostatectomy (Abstract number 1882) [.]. Journal of Urology 2009;181(4 Suppl):680. [SR‐INCONT42736]

Robinson 2008 {published data only}

Robinson JP, Bradway CW, Nuamah I, Pickett M, McCorkle R. Systematic pelvic floor training for lower urinary tract symptoms post‐prostatectomy: a randomized clinical trial. Internatonal Journal of Urological Nursing 2008;2(1):3‐13. [SRINCONT34593]

Robinson 2009 {published data only}

Robinson J, Weiss R, Avi‐Itzhak T, McCorkle R. Pilot‐testing of a theory‐based pelvic floor training intervention for radical prostatectomy patients (Abstract number 88). Neurourology and Urodynamics 2009;28(7):682‐3. [SRINCONT34587]

Seleme 2008 {published data only}

Seleme M, Ribeiro V, Moreno A, Berghmans B, Bendhack M. Efficacy of physiotherapy after radical prostatectomy (Abstract number 256). Proceedings of the International Continence Society (ICS), 38th Annual Meeting, 2008 Oct 20‐24, Cairo, Egypt. 2008. [SRINCONT31842]

Tibaek 2007 {published data only}

Tibaek S, Klarskov P, Hansen BL, Thomsen H, Andresen H, Jensen CS, et al. Pelvic floor muscle training before transurethral resection of the prostate: A randomized, controlled, blinded study. Scandinavian Journal of Urology and Nephrology 2007;41(4):329‐34. [SRINCONT23879]
Tibaek S, Klarskov P, Lund Hanzen B, Thomsen H, Andresen H, Schmidt Jensen C, et al. Pelvic floor muscle training before transurethral resection of the prostate (Abstract number 31).. Neurourology and Urodynamics 2006;25(6):546‐7. [SR‐INCONT26614]

Tienforti 2012 {published data only}

Sacco E, Tienforti D, D'Addessi A, Racioppi M, Gulino G, Pinto F, et al. Efficacy of a supervised, affordable program of perioperative pelvic floor muscle training in improving the recovery of continence after radical prostatectomy: a randomized controlled trial (Abstract number 138). Neurourology and Urodynamics 2011;30(6):995‐7. [SR‐INCONT42188]
Sacco E, Tienforti D, Marangi F, D'Addessi A, Racioppi M, Gulino G, et al. Efficacy of a supervised low‐intensity regimen of perioperative pelvic floor muscle training in reducing postprostatectomy urinary incontinence: A randomized controlled trial (Abstract number 286). European Urology Supplements 2012;11(1):e286. [sr‐incont47271]
Tienforti D, Sacco E, Marangi F, D'Addessi A, Racioppi M, Gulino G, et al. Efficacy of an assisted low‐intensity programme of perioperative pelvic floor muscle training in improving the recovery of continence after radical prostatectomy: a randomized controlled trial. BJU International 2012;110(7):1004‐10. [SR‐INCONT45339]

Tobia 2008 {published data only}

Tobia I, Gonzalez MS, Martinez P, Tejerizo JC, Gueglio G, Damia O, et al. [Randomized study on urinary continence after radical prostatectomy with previous kinesic perineal physiotherapy]. [Spanish]. Archivos Espanoles de Urologia 2008;61(7):793‐8. [SRINCONT27688]

van Kampen 1998 {unpublished data only}

Van Kampen M, De Weerdt W, Van Poppel H, Baert L. Urinary incontinence after radical prostatectomy can be treated by pelvic floor re‐education and predicted by measuring urine loss at catheter withdrawal: a controlled study. Proceedings of the International Continence Society (ICS), 29th Annual Meeting; 1999 Aug 22‐26; Denver, Colorado. 1999:246‐7. [SR‐INCONT9919]
Van Kampen M, De Weerdt W, Van Poppel H, De Ridder D, Feys H, Baert L. Effect of pelvic floor re‐education on duration and degree of incontinence after radical prostatectomy: a randomised controlled trial. Lancet 2000;355(9198):98‐102. [SRINCONT9012]
Van Kampen M, De Weerdt W, Van Poppel H, De Ridder D, Feys H, Baert, L. The efficacy of physiotherapy on the degree and the duration of incontinence after radical prostatectomy: a randomised controlled study [abstract]. Neurourology and Urodynamics 1998;17(4):49‐50. [SRINCONT5681]
van Kampen M, De Weerdt W, Van Poppel H, De Ridder D, Feys H, Baert L. The efficacy of physiotherapy on the degree and the duration of incontinence after radical prostatectomy: a randomised controlled study. [Unpublished doctoral thesis]. Belgium: University of Leuven, 1998. [SRINCONT5732]

Wille 2003 {published and unpublished data}

Wille S, Sobottka A, Heidenreich A, Hofmann R. Pelvic floor exercises, electrical stimulation and biofeedback after radical prostatectomy: Results of a prospective randomized trial. Journal of Urology 2003;170(2 Part 1):490‐3. [SRINCONT16931]
Wille S, Sobottka A, Olbert P, Heidenreich A, Hofmann R. Impact of electrical stimulation or biofeedback on quality of life after radical prostatectomy: Results of a prospective randomized trial (Abstract number 167). Journal of Urology 2004;171(4 Suppl):44. [SRINCONT27408]

Yamanishi 2006 {published data only}

Yamanishi K, Mizuno T, Sakakibara R, Uchiyama T, Ito Y, Yamamoto T, et al. A randomized, placebo‐controlled, double‐blind study of electrical stimulation with pelvic floor muscle training for the treatment of urinary incontinence after radical prostatectomy (Abstract number 30). Neurourology and Urodynamics 2006;25(6):545‐6. [SRINCONT26613]
Yamanishi T, Mizuno T, Watanabe M, Honda M, Yoshida K‐I. Randomized, placebo controlled study of electrical stimulation with pelvic floor muscle training for severe urinary incontinence after radical prostatectomy. Journal of Urology 2010;184(5):2007‐12. [SR‐INCONT40344]

Yokoyama 2004 {published data only}

Yokoyama T, Nishiguchi J, Watanabe T, Nose H, Nozaki K, Fujita O, Inoue M, et al. Comparative study of effects of extracorporeal magnetic innervation versus electrical stimulation for urinary incontinence after radical prostatectomy. Urology 2004;63(2):264‐7. [SRINCONT17116]

Zhang 2007 {published data only}

Zhang AY, Galanek J, Strauss GJ, Siminoff LA. What it would take for men to attend and benefit from support groups after prostatectomy for prostate cancer: a problem‐solving approach. Journal of Psychosocial Oncology 2008;26(3):97‐112. [SRINCONT29254]
Zhang AY, Strauss GJ, Siminoff LA. Effects of combined pelvic floor muscle exercise and a support group on urinary incontinence and quality of life of postprostatectomy patients. Oncology Nursing Forum Online 2007;34(1):47‐53. [SRINCONT31506]
Zhang AY, Strauss GJ, Siminoff LA. Intervention of urinary incontinence and quality of life outcome in prostate cancer patients. Journal of Psychosocial Oncology 2006;24(2):17‐30. [SRINCONT22147]

Bennett 1997 {published data only}

Bennett JK, Foote JE, Green BG, Killorin EW, Martin SH. Effectiveness of biofeedback/electrostimulation in the treatment of post prostatectomy urinary incontinence [abstract]. Proceedings of the Urodynamics Society Annual Meeting. 1997.

Bocker 2002 {published data only}

Bocker B, Smolenski UC. [Physikalische therapie der beckenbodeninsuffizienz‐ methodenvergleich]. Journal fur Urologie und Urogynakologie 2002;2:20‐7.

Burkert 2011 {published data only}

Burkert S, Scholz U, Gralla O, Roigas J, Knoll N. Dyadic planning of health‐behavior change after prostatectomy: a randomized‐controlled planning intervention. Social Science & Medicine 2011;73(5):783‐92. [srincont46861]

Ceresoli 2002 {unpublished data only}

Ceresoli A, Kartalas Goumas J, Colombo F, Barbetti E, Dell'Aglio F, Bonacina P, et al. Daily transcutaneous electrical nerve stimulation (DTENS) after radical perineal prostatectomy: A free cost effective biofeedback technique in the treatment of post operative urinary incontinence (abstract). Proceedings of the 32nd Annual Meeting of the International Continence Society; 2002 Aug 28‐30; Heidelberg, Germany. 2002.

Chang 1998 {published data only}

Chang PL, Tsai LH, Huang ST, Hsieh ML, Tsui KH. The early effect of pelvic floor muscle exercise after transurethral prostatectomy. Journal of Urology 1998;160(2):402‐5.

Cornel 2005 {published data only}

Cornel EB, de Wit R, Witjes JA. Evaluation of early pelvic floor physiotherapy on the duration and degree of urinary incontinence after radical retropubic prostatectomy in a non‐teaching hospital. World Journal of Urology 2005;23:353‐5.

Cornu 2011 {published data only}

Cornu JN, Merlet B, Ciofu C, Mouly S, Peyrat L, Sebe P, et al. Duloxetine for mild to moderate postprostatectomy incontinence: preliminary results of a randomised, placebo‐controlled trial. European Urology 2011;59(1):148‐54. [SR‐INCONT41370]

Crevenna 2003 {published data only}

Crevenna R, Zoch C, Kellani M, Quittan M, Fialka‐Moser V. Implementation of a physical rehabilitation group for post‐prostatectomy urinary incontinence patients and its effects on quality of life. Physikalische Medicin Rehabilitationsmedizin Kurotmedizin 2003;13(6):339‐44.

Dieperink 2013 {published data only}

Dieperink KB, Johansen C, Hansen S, Wagner L, Andersen KK, Minet LR, et al. The effects of multidisciplinary rehabilitation: RePCa‐a randomised study among primary prostate cancer patients. British Journal of Cancer 2013;109(12):3005‐13.

Eren 2013 {published data only}

Alan C, Ersay AR, Eren AE, Altintas R, Kocoglu H, Basturk G. Efficacy of early duloksetin therapy in urinary incontinence occurred after radical prostatectomy (Abstract number 704). Proceedings of the 43rd Annual Meeting of the International Continence Society (ICS), 2013 Aug 26‐30, Barcelona, Spain2013. [sr‐incont49727]
Eren AE, Alan C, Bastruk G. Efficacy of early duloxetine therapy in urinary incontinence occurred after radical prostatectomy (Abstract number 25226). BJU International 2013;112 Suppl S1:18‐9. [sr‐incont49943]
Eren AE, Ersay AR, Alan C, Basturk G. Efficacy of early Duloksetin therapy in urinary incontinence occurred after radical prostatectomy (Abstract number S90). European Urology Supplements 2013;12(4):e1198. [sr‐incont49916]

Filocamo 2007 {published data only}

Del Popolo G, Filocamo M, Li Marzi V, Cecconi F, Marzocco M, Nicita G. Stress incontinence after radical prostatectomy: a randomized controlled trial on combination of duloxetine and rehabilitation versus rehabilitation alone (Abstract number 29). Neurourology and Urodynamics 2006;25(6):544‐5. [SR‐INCONT26612]
Filocamo MT, Li Marzi V, Del Popolo G, Cecconi F, Villari D, Marzocco M, et al. Pharmacologic treatment in postprostatectomy stress urinary incontinence. European Urology 2007;51(6):1559‐64. [23000]

Griebling 1999 {published data only}

Griebling TL, Kreder KJ, Sueppel CA, See WA. Timing of biofeedback and pelvic floor muscle exercise training for men undergoing radical prostatectomy (Abstract number 322). Proceedings of the 29th Annual Meeting of the International Continence Society; 1999 Aug 22‐26; Denver, Colorado. 1999:401. [SR‐INCONT9928]
Sueppel C, Kreder K, See W. Improved continence outcomes with preoperative pelvic floor muscle strengthening exercises. Urologic Nursing 2001;21:201‐10.

Hotston 2006 {published data only}

Hotston MR, Hurley K, Patel S, Persad R. The use of duloxetine for stress incontinence after prostatectomy. BJU International 2006;98(4):916‐7. [26028]

Ip 2004 {published data only}

Ip V. Evaluation of a patient education tool to reduce the incidence of incontinence post‐prostate surgery. Urologic Nursing 2004;24(5):401‐7.

Kahihara 2006 {published data only}

Kahihara CT, Ferreira U, Pedro RN, Matheus WE, Netto NR. [Early versus delayed physiotherapy in the treatment of post‐prostatectomy male urinary incontinence]. Archivos Espanoles de Urologia 2006;59(8):773‐8.

Lin 2012 {published data only}

Lin YH, Yu TJ, Lin VC, Wang HP, Lu K. Effects of early pelvic‐floor muscle exercise for sexual dysfunction in radical prostatectomy recipients. Cancer Nursing 2012;35(2):106‐14. [SR‐INCONT46858]

McGlynn 2004 {published data only}

McGlynn B, Al‐Saffar N, Begg H, Gurun M, Hollins G, McPhee S, et al. Management of urinary incontinence following radical prostatectomy. Urologic Nursing 2004;24(6):475‐82.

Mishel 2002 {published data only}

Mishel MH, Belyea M, Germino BB, Stewart JL, Bailey DE, Robertson C, et al. Helping patients with localized prostate carcinoma manage uncertainty and treatment side effects: nurse‐delivered psychoeducational intervention over the telephone. Cancer 2002;94(6):1854‐66. [sr‐incont15336]

Nehra 2001 {published data only}

Nehra A, Rovner E, Wein A, Lange P, Ellis W, Keane R, et al. Interim analysis of a multi‐center study of extracorporeal magnetic innervation (ExMI) for the treatment of urinary incontinence following radical prostatectomy (Abstract). Proceedings of the 31st Annual Meeting of the International Continence Society; 2001 Sept 18‐21; Seoul, Korea. 2001.

Ottenbacher 2013 {published data only}

Ottenbacher A, Sloane R, Snyder DC, Kraus W, Sprod L, Demark‐Wahnefried W. Cancer‐specific concerns and physical activity among recently diagnosed breast and prostate cancer survivors. Integrative Cancer Therapies 2013;12(3):206‐12. [sr‐incont50477]

Pemberton 2006 {published data only}

Pemberton P, Brooks A, Eriksen CM, Frost S, Graham S, Greenman L, et al. A comparative study of two types of urinary sheath. Nursing Times 2006;102(7):36‐41.

Prota 2012 {published data only}

Prota C, Gomes CM, Ribeiro LH, de Bessa J, Nakano E, Dall'Oglio M, et al. Early postoperative pelvic‐floor biofeedback improves erectile function in men undergoing radical prostatectomy: a prospective, randomized, controlled trial. International Journal of Impotence Research 2012;24(5):174‐8. [SR‐INCONT45891]

Pulker 2002 {published data only}

Pulker E. Long term results of physiotherapy in men with urinary stress incontinence after radical prostatectomy (Abstract). Proceedings of the 32nd Annual Meeting of the International Continence Society; 2002 Aug 28‐30; Heidelburg, Germany. 2002.

Ribeiro 2013 {published data only}

Ribeiro AM, Oliveira HF. Pelvic Floor Muscles Training in Urinary Disorders in Men With Prostate Cancer Undergoing Radiotherapy. http://clinicaltrials.gov/show/NCT017629562013. [NCT01762956; sr‐incont47831]

Ricci 2004 NEWa {published data only}

Ricci L, Minardi D, Romoli M, Galosi AB, Muzzonigro G. Acupuncture reflexotherapy in the treatment of sensory urgency that persists after transurethral resection of the prostate: a preliminary report. Neurourology and Urodynamics 2004;23(1):58‐62. [SR‐INCONT16645]

Robinson 2012 {published data only}

Robinson JP, Burrell SA, Avi‐Itzhak T, McCorkle R. Validity testing of the stopwatch urine stream interruption test in radical prostatectomy patients. Journal of Wound, Ostomy & Continence Nursing 2012;39(5):545‐51. [SR‐INCONT45900]

Salinas Casado 1991 {published data only}

Salinas Casado J, Varela E, Prieto Chaparro L, Virseda Rodriguez M, Salomon S, Guerrero A, et al. Results of perineal electric stimulation in stress urinary incontinence [Resultatos de la estimulacion electrica perineal en la incontinencia urinaria de esfuerzo]. Archivos Espanoles di Urologia 1991;44(4):437‐40.

Salinas Casado 1996 {published data only}

Salinas Casado J, Virseda Chamorro M, Salomon Mohamed S, Bravo de Rueda C, Aristizabal JM, Resel Estevez L. Results of electrical stimulation in the treatment of post‐prostatectomy urinary incontinence. Actas Urologicas Espanolas 1996;20(6):544‐50.

Seki 2005 {published data only}

Seki N, Kai N, Takano N, Naito S, Kawajiri M, Kira J, Tobimatsu S. Efficacy of high‐frequency magnetic stimulation of the sacral root in patients with stress urinary incontinence following radical prostatectomy [abstract]. 35th Annual Meeting of International Continence Society; 2005 Aug 29 ‐ Sep 2; Montreal, Canada.

Shen 2012 NEWa {published data only}

Shen YZ, Lin X, Lin Q. [Overactive bladder after transurethral resection of prostate treated with electroacupuncture therapy and tolterodine]. Zhongguo Zhen Jiu = Chinese acupuncture & moxibustion 2012;32(5):404‐8. [SR‐INCONT47454]

Traeger 2013 {published data only}

Traeger L, Penedo FJ, Benedict C, Dahn JR, Lechner SC, Schneiderman N, et al. Identifying how and for whom cognitive‐behavioral stress management improves emotional well‐being among recent prostate cancer survivors. Psycho‐Oncology 2013;22(2):250‐9. [sr‐incont48709]

Yang 2010 NEWa {published data only}

Yang BS, Ye DW, Yao XD, Peng JY, Zhang SL, Dai B, et al. [The study of electrical acupuncture stimulation therapy combined with pelvic floor muscle therapy for postprostatectomy incontinence]. [Chinese]. Chung‐Hua Wai Ko Tsa Chih [Chinese Journal of Surgery] 2010;48(17):1325‐7. [SR‐INCONT42595]

Yao 2012 {published data only}

Yao J, Hirschhorn AD, Mungovan SF, Patel MI. Preoperative pelvic floor physiotherapy improves continence following radical prostatectomy (Abstract number 182). Neurourology and Urodynamics 2012;31(6):964‐5. [sr‐incont50072]

Zahariou 2009 {published data only}

Zahariou A, Kyriakides A. Intensive pelvic floor muscle training after radical prostatectomy improves continence outcomes (Abstract number S40). European Urology Supplements 2009;8(8):620. [sr‐incont49168]

Zermann 1999 {published and unpublished data}

Zermann DH, Ishgooka M, Wunderlich H, Wilhelm S, Schubert J. Post‐prostatectomy incontinence and pelvic floor dysfunction (abstract). Proceedings of the 29th Annual Meeting of the International Continence Society; 1999 Aug 22‐26; Denver, Colorado. 1999.
Zermann DH, Ishigooka M, Wunderlich H, Reichelt O, Schubert J. A study of pelvic floor function pre‐and post radical prostatectomy using clinical neurourological investigations, urodynamics and electromyography. European Urology 2000;37:72‐8.

Zhang 2009 {published data only}

Zhang A, O'Neill J. Improving Continence and Quality of Life in Prostate Cancer Patients (StayDry). http://clinicaltrials.gov/show/NCT013651822009. [NCT01365182; StayDry; sr‐incont47806]

Crivellaro 2011 {published data only}

Abbinante M, Crivellaro S, Palazzetti A, Tosco L, Frea B. Efficacy of ultrasound‐guided pelvic muscle training (Abstract number 45). Neurourology and Urodynamics 2012;31 Suppl 1:S35. [sr‐incont47301]
Crivellaro S, Abbinante M, Palazzetti A, Tosco L, Frea B. Efficacy of ultrasound‐guided pelvic muscle training (Abstract number 285). European Urology Supplements 2012;11(1):e285a. [sr‐incont47272]
Crivellaro S, Lorenzo T, Abbinante M, Martinez G, Palazzetti A, Frea B. Efficacy of pelvic training under transrectal ultrasonography (Abstract number 16). Neurourology and Urodynamics 2011;30 Suppl 1:13‐4. [sr‐incont47397]

Delmastro 2010 {published data only}

Delmastro F, Marchisio C, Lamberti G, Giraudo D. Urinary incontinence after radical prostatectomy: a randomized controlled trial comparing preoperative intensive pelvic muscle exercises with or without proprioceptive training (Abstract). Neurourology and Urodynamics 2010;29(2 Suppl):62‐3. [SR‐INCONT39878]

Lilli 2006 NEW {published data only}

Lilli P, Mercuriali M, Fiori M, Hanitzsch H, Gunelli R, Bercovich E. Impact of preoperative biofeedback on incontinence in cancer patients undergoing radical prostatectomy. Archivio Italiano di Urologia e Andrologia 2006;78(3):92‐6. [SR‐INCONT25089]

Simeit 2010 NEW {published data only}

Simeit R, Deck R, Drechsler T, Fiedrich M, Schonrock‐Nabulsi P. [Quality of life and impact of incontinence in male patients with prostate carcinoma after radical retropubic prostatectomy]. [German]. Rehabilitation 2010;49(3):180‐9. [SR‐INCONT40661]

Zellner 2011 NEW {published data only}

Zellner M. [Incontinence after radical prostatectomy and cystectomy: are combined training with mechanical devices and whole body vibration effective?]. [German]. Urologe (Ausg.A) 2011;50(4):433‐44. [SR‐INCONT41808]

Zhang 2013 {published data only}

Zhang A. The problem‐solving therapy and urinary incontinence in prostate cancer patients (Abstract number 14‐5). Psycho‐Oncology 2013;22 Suppl 2:33‐4. [NCT01365182; sr‐incont49941]

Burnett 2012 {published data only}

NCT01748110, Burnett AL, Segal RL, Cheskin LJ, Blitz JU. Health Interventions in Men Undergoing Radical Prostatectomy ‐ A Randomized Controlled Clinical Trial. http://clinicaltrials.gov/show/NCT017481102012.

Burnett 2013 {published data only}

Burnett AL, Tajkarimi K. Study of non‐invasive Viberect© penile vibratory stimulation regimen to enhance recovery of erectile function/rigidity and urinary control/continence after nerve sparing radical prostatectomy (RP) for clinically localized prostate cancer. http://clinicaltrials.gov/show/NCT017187042013. [NCT01718704; sr‐incont49360]

Fode 2012 NEW {published data only}

Fode M. Mechanical nerve stimulation in the treatment of post prostatectomy incontinence. http://clinicaltrials.gov/show/NCT015406562012. [NCT01540656; sr‐incont49358]

Goode 2014 {published data only}

Goode PS. Perioperative Post‐Prostatectomy Incontinence Home Telehealth Program (ProsTel). http://clinicaltrials.gov/show/NCT019609982014. [NCT01960998; ProsTel; sr‐incont49364]

Mina 2013 {published data only}

NCT02036684, Mina DS, Matthew AG, Carli F. A Multicentre, Pilot Randomized Controlled Trial to Examine the Effects of Prehabilitation on Functional Outcomes After Radical Prostatectomy. http://clinicaltrials.gov/show/NCT020366842013.

Ng 2011 {published data only}

Ng S‐I. A Randomized Controlled Trial Study of the Efficacy of Intensive Preoperative Pelvic Floor Muscle Training to Decrease Post‐prostatectomy Urinary Incontinence. http://clinicaltrials.gov/show/NCT013385842011. [NCT01338584; sr‐incont47833]

Terrone 2007 {published data only}

Terrone C, Cisari C. Prevention of Urinary Incontinence After Prostatectomy. http://clinicaltrials.gov/show/NCT009820982007. [NCT00982098; sr‐incont47873]

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Zopf EM, Braun M, Machtens S, Zumbe J, Bloch W, Baumann FT. Implementation and scientific evaluation of rehabilitative sports groups for prostate cancer patients: study protocol of the ProRehab Study. BMC Cancer 2012;12:312. [DRKS00004184; SR‐INCONT45125]

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Altman D, Cartwright R, Lapitan MC, Nelson R, Sillen U, Tikkinen K. Epidemiology of Urinary Incontinence (UI) and other Lower Urinary tract Symptoms (LUTS), Pelvic organ Prolapse (POP) and Anal Incontinence (AI). In: Abrams P, Cardozo L, Khoury S, Wein A editor(s). Incontinence: 5th International Consultation on Incontinence. Recommendations of the International Scientific Committee: evaluation and treatment of urinary incontinence, pelvic organ prolapse and faecal incontinence; 2012 Feb 23‐25; Paris. Belgium: International Consultation on Urological Diseases, 2013:27‐9.

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Wilson L, Brown J, Shin GP, Luc K, Subak L. Annual direct cost of urinary incontinence. Obstetrics and Gynecology 2001;98(3):398‐406.

Winters 1997

Winters JC, Rackley RR, Fralick RA, Simich SC, Appell RA. Urodynamic findings in post‐prostatectomy incontinence [Abstract 398]. Journal of Urology 1997;157 Suppl 4:102.

Campbell 2012

Campbell SE, Glazener CMA, Hunter KF, Cody JD, Moore KN. Conservative management for postprostatectomy urinary incontinence. Cochrane Database of Systematic Reviews 2012, Issue 1. [DOI: 10.1002/14651858.CD001843.pub4]

Hunter 2004

Hunter KF, Moore KN, Cody DJ, Glazener CMA. Conservative management for postprostatectomy urinary incontinence. Cochrane Database of Systematic Reviews 2004, Issue 2. [DOI: 10.1002/14651858.CD001843.pub2]

Hunter 2007

Hunter KF, Moore KN, Glazener CMA. Conservative management for postprostatectomy urinary incontinence. Cochrane Database of Systematic Reviews 2007, Issue 2. [DOI: 10.1002/14651858.CD001843.pub3]

Moore 1999b

Moore KN, Cody DJ, Glazener CM. Conservative management for post prostatectomy urinary incontinence. Cochrane Database of Systematic Reviews 1999, Issue 4. [DOI: 10.1002/14651858.CD001843]

Moore 2001

Moore KN, Cody DJ, Glazener CM. Conservative management for post prostatectomy urinary incontinence. Cochrane Database of Systematic Reviews 2001, Issue 2. [DOI: 10.1002/14651858.CD001843]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ahmed 2012

Methods

RCT

Participants

Time of recruitment: Pre‐operatively

Population: 95 men after radical prostatectomy (whole population, with or without UI)

Included: men who underwent RP for clinically localized prostate cancer. Patients were not taking anticholinergic drugs or any drug that may affect continence for the duration of the study

Excluded: previous urethral, bladder or prostate surgery, prior urinary or faecal incontinence, neurogenic and psychiatric disorders, pre‐operative urinary tract complications, radiotherapy

Age (mean, SD): A 57.2 (3.25); B 58.8 (5.4); C 56.3 (6.8)

Dropouts: 10 A: 4 (2 received radiotherapy, 2 had post‐operative complications); B: 4 (2 received radiotherapy, 2 refused follow up); C: 2 (2 received radiotherapy) No differential dropout

Baseline characteristics: Comparable at baseline

Interventions

Time of intervention: Post‐operative treatment

A (26): PFMT alone. At catheter removal men received standard care of verbal and written instructions, active instructions from physiotherapist to perform 3 sets of 15 to 20 contractions daily, for a duration of 3 to 5 seconds with a 6 to 10 second rest period, encouraged to perform exercises before functional activities such as sneezing, coughing, or lifting weight, also in the supine position, sitting, squatting and going up and down stairs.

B (26): ES: treatment started one week after catheter removal, patients received 15 minutes of twice weekly electrical stimulation for 12 weeks

C (28): PFMT + BFB + ES: treatment started one week after catheter removal, patients received twice weekly treatment with 15 minutes of electrical stimulation and 15 minutes of biofeedback for 12 weeks, instructed to perform 3 series of 10 rapid contractions, 3 sustained contractions of 5, 7 or 10 seconds and then 10 contractions during prolonged expiration in the supine position

All patients were given a logbook to complete daily regarding self‐report of exercises

Duration of treatment:  12 weeks

Follow up: 6, 12 and 24 weeks

Outcomes

Primary outcome (number of men with UI)

Number of incontinent men (defined as some pads required and weight gain of the pad > 1 g during the test)

Baseline: A 22/26; B 22/26; C 23/28

2 months: A 21/26; B 19/26; C 18/28

3 months: A 17/26; B 12/26; C 20/28

6 months: A 9/26; B 6/26; C 1/28

Other outcomes

Leakage weight in grams on 24 hour pad test (mean (SD) N)

Baseline: A 791 (380.3) 26; B 790 (399.46) 26; C 785 (311.98) 28

2 months: A 533 (316.53) 26;  B 383 (145.87) 26; C 263 (145.87) 28

3 months : A 260 (216.53) 26; B 132 (145.87) 26; C 83 (145.87) 28

6 months : A 123 (116.53) 26; B 98 (105.87) 26; C 36 (95.87) 28

Quality of life

(Higher score = worse)

Mean scores of IIQ‐7 (mean (SD) N)

2 months: 40 (23) 26; B 36 (25) 26; C 26 (25) 28

3 months: 32 (26) 26; B 29 (28) 26; C 20 (24) 28

6 months: 25 (26) 26; B 23 (24) 26; C 15 (25) 28

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomised using “a computer‐generated random‐number list”

Allocation concealment (selection bias)

Low risk

“sealed envelopes”

Blinding of participants (performance bias)

High risk

Blinding to treatment not possible

Blinding of personnel (performance bias)

Unclear risk

“One experienced physiotherapist delivered all therapy”

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No information provided. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

4 (2 received radiotherapy, 2 had post‐operative complications); B: 4 (2 received radiotherapy, 2 refused follow‐up); C: 2 (2 received radiotherapy). No differential dropout

Selective reporting (reporting bias)

Low risk

All outcomes in methods were reported

Financial support

Unclear risk

Not reported. Therefore judged to be unclear risk.

Approved by medical ethics committee

Low risk

“At the time of this study, there was no Human Research Ethics Committee established in the faculty, but the study was approved by the postgraduate affairs and departmental committee”

Informed consent

Low risk

“All patients signed an informed consent form”

ITT analysis

Low risk

Assumed from flow diagram of patients

Bales 2000

Methods

Randomised: yes
Method of allocation: not stated
Blinding: Outcome assessment nurse not involved in intervention
Dropouts: None mentioned

Participants

Recruitment: pre‐operative

Included: all men undergoing radical prostatectomy

N = 100 consecutive patients with stage T1c to T2c prostate cancer undergoing radical retropubic prostatectomy by a single surgeon randomised into 2 groups

Interventions

Pre‐operative intervention

Group A (50) intervention: 2 to 4 weeks prior to surgery, participants underwent a 45 minute session with nurse trained in biofeedback. Patients were instructed to perform graded PFMT. Contractions of 5 to 10 seconds, 10 to 15 repetitions were performed with biofeedback (surface electrodes used to measure muscle strength). Advised to practice the exercises 4 times per day until surgery

Group B (50) control: no biofeedback training. Written and brief verbal instructions from a nurse on how to perform PFMT (isolate muscle that stops urine flow, practice 4 times per day, 10 to 15 repetitions)

Both groups: Encouraged to perform PME 4 times per day after catheter removal 2 weeks post‐operatively

Length of follow‐up: 6 months

Outcomes

Main outcome: time to return of continence measured by number of pads used

Continence definition: use of 1 pad or less per day

Data collection: at 1, 2, 3, 4, and 6 months post‐operatively

There was no significant difference in incontinence between the groups

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No description

Allocation concealment (selection bias)

Unclear risk

"Randomised"

Blinding of participants (performance bias)

High risk

Blinding not possible

Blinding of personnel (performance bias)

High risk

Blinding to intervention not possible

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Outcome assessment nurse not involved in intervention

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Three patients dropped out of the biofeedback arm of the study because they never completed their biofeedback session

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Unclear risk

No description

Approved by medical ethics committee

Unclear risk

Not reported

Informed consent

Unclear risk

Not reported

ITT analysis

Unclear risk

Not specified

Burgio 2006

Methods

Randomised: yes
Method of allocation: stratified by age and tumour differentiation, then randomised using computer generated random numbers, block size of 4 to ensure equity of number in each group
Blinding: intervention providers and bladder diary scorers were blinded
Dropouts: 6 participants in the intervention group, and 7 in the control were excluded after randomisation as surgery was cancelled. At 6 months, 6 in the intervention and 4 in the control were lost to follow‐up

Participants

Recruitment: pre‐operative

Included: all men undergoing radical prostatectomy

N = 125 volunteer patients randomised, 13 excluded after randomisation

Analysis on N = 112 men aged 53 to 68 years who underwent radical prostatectomy for prostate cancer. To be eligible, the men had to be ambulatory, continent and identified at least 1 week prior to their surgery

Interventions

Pre‐operative intervention

Group A (57) intervention: single session of biofeedback (rectal probe to measure intra‐abdominal rectal pressure and external anal sphincter contraction) assisted behavioural training. Feedback and verbal instruction used to teach control of pelvic muscles. Taught to contract sphincter during 2 to 10 seconds periods separated by 2 to 10 seconds of relaxation, dependent on ability. Written instructions for daily at home practice of 45 PFM exercises daily (3 sessions of 15 exercises each time). Additionally instructed to slow or interrupt voiding once daily. Encouraged to exercise daily preoperatively, then resume when catheter removed post‐operatively

Group B (55) control: usual care of brief verbal instructions post operatively to interrupt the voiding stream plus any instruction from physician

Length of follow‐up: 6 months

Outcomes

Main outcome:
Continual or episodic urine loss using bladder diaries, incontinent pads or other products
Secondary outcomes:
Impact of incontinence and quality of life pre‐operatively and at follow‐up contacts by IIQ, SCL‐90‐R and SF‐36

Continence definition: 3 consecutive weekly 1 day diaries showing no leakage or a 7 day diary showing no leakage

Data collection: 1 day bladder diaries mailed in each week. Questionaire on bladder control, lifestyle and 7 day bladder diary at 6 weeks, 3 months and 6 months post‐surgery

Time to continence was significantly reduced in the intervention group. The intervention group had a significantly smaller proportion of those with severe or continual leakage at 6 months, and stress type urine loss. No differences on quality of life, return to work or activities between the groups

Notes

Analysis by "intention to treat". Additional data supplied to KFH by author

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Stratified by age and tumour differentiation, then randomised using computer generated random numbers, block size of 4 to ensure equity of number in each group

Allocation concealment (selection bias)

Low risk

Computer allocated. "The randomization schedule was implemented by the research nurse, so that interventionists would be blinded to the next group assignment."

Blinding of participants (performance bias)

High risk

Blinding to intervention not possible

Blinding of personnel (performance bias)

Low risk

Intervention providers and bladder diary scorers were blinded

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Bladder diary scorers were blinded

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

6 and 4 lost to follow‐up at 6 months; 6 and 7 excluded after randomisation as surgery cancelled

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Low risk

"Supported by Grant RO1 DK50283 from the National Institute for Diabetes and Digestive and Kidney Diseases, National Institutes of Health"

"The funding organization did not participate in the design or conduct of the study; collection, management, analysis or interpretation of the data; or the preparation, review or approval of the manuscript."

Approved by medical ethics committee

Low risk

"This study was reviewed and approved by the University and VA Medical center Institutional Review Boards for Human use"

Informed consent

Unclear risk

"All participants provided informed consent"

ITT analysis

Low risk

"intention to treat". Patient flow diagram

Centemero 2009

Methods

Randomised: yes

Method of allocation: 100 consecutive patients

Blinding: no

Participants

Number of men 100

Recruitment: pre‐operative

Included: all men undergoing radical prostatectomy

Excluded: impaired mental status, BMI.27, diabetes mellitus, neurological‐rheumatic‐immune disease, neck‐urethral surgery, prior catheterisation, post‐operative catheterisation time longer than 6 days.

Aged: 48‐68 years

Interventions

Group A (50) intervention: PFMT both pre and post‐operatively. A structured PFMT program 30 and 15 days before surgery, previous physiotherapist evaluation to provide the patients with feedback about the quality of pelvic floor muscle function, PC test (endurance and contraction quality), breathing co‐ordination, typify muscle contraction as tonic and modify incorrect physical attitudes. This was also repeated after the procedure

Group B (50) intervention: PFMT post‐operatively only (no details as to whether this is the same as the treatment pre‐operatively above)

Duration of treatment: not stated

Length of follow‐up: at one and three months

Outcomes

UI at

1 month: A 33/59; B 47/59

3 month: A 24/59; B 37/59

24 hour pad test, number of subjects with pad test weight of > 150 g

1 month: A 15/59; B 20/59

3 month: A 10/59; B 19/59

Quality of life measured by the ICS male sf questionnaire, mean score

1 month: A 14.6 (6.36) 59; B 18.3 (6.36) 59

3month: A 8.1 (7.04) 59; B 12.2 (6.36) 59

Satisfaction scale (PGI‐I) used only for Group A and 75% reported extreme satisfaction for pre‐operative PFMT

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Individuals were randomised by a computer‐generated list that was centrally maintained". "Permuted block randomisation was used, with a block size of every 10 consecutively enrolled participants"

Allocation concealment (selection bias)

Low risk

"Individuals were randomised by a computer‐generated list that was centrally maintained". "Permuted block randomisation was used, with a block size of every 10 consecutively enrolled participants"

Blinding of participants (performance bias)

High risk

Blinding not possible

Blinding of personnel (performance bias)

Low risk

"The surgeon who performed the procedures was blinded to randomisation allocation throughout the study"

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

"Only the statistician and the data monitoring committee saw unblinded data"

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No description. It appears that there were was no loss to follow‐up

Selective reporting (reporting bias)

Unclear risk

Protocol not available. Therefore judged to be unclear risk

Financial support

Low risk

None

Approved by medical ethics committee

Low risk

"The study was approved by the university institutional review board"

Informed consent

Low risk

Patients were "provided written informed consent"

ITT analysis

Low risk

Assumed from patient flow chart

Dijkstra‐Eshuis 2013

Methods

RCT

Participants

Time of recruitment: pre‐operative

Population: men having a laparoscopic radical prostatectomy (whole population, with or without UI)

Included: patients with prostate cancer, undergoing laparoscopic radical prostatectomy

Excluded:  neurological disorders, a medical history with invasive perineal and/or rectal surgery, preoperatively existing stress urinary incontinence, radiation, ≥ 75 years

Age (mean, SD): A 63.7 (5.3); B 63.7 (5.3)

Dropouts: 9 from A (1 unable to understand Dutch, 3 post‐operative radiotherapy, 1 oesophageal cancer, 3 discontinued intervention at own request, 1 excluded due to poor compliance) 8 from B (2 post operative radiotherapy, 1 pelvic lymph node dissection, 1 died of cause unrelated to prostate cancer, 5 discontinued intervention at own request, 1 prolonged catheter) Not differential dropout

Baseline characteristics:  comparable at baseline

Interventions

Time of intervention: pre‐operative (+ postoperative treatment for all men)

A (56): 30 mins of guided PFMT + biofeedback weekly for 4 weeks before surgery, received written instructions to: carry out two sets of 30 contractions during abdominal breathing, one breath between each contraction; restart PFMT after catheter removal (7 to 10 days after surgery)

B (46): received written instructions on PFMT after catheter removal (7 to 10 days after surgery)

All men were seen before surgery by a physiotherapist, who explained relevant anatomy, anal visual inspection and digital palpation, biofeedback registration with rectal probe

All patients received PFMT + biofeedback and/or electrical stimulation if still incontinent after 6 weeks

Duration of treatment

Follow up: 6 weeks, 3 months, 6 months, 9 months and 12 months after surgery

Outcomes

Primary outcome (number of men with UI)

Number of incontinent men (leakage on 24 hour pad test)

12 months: A 20/58; B 9/45

Other outcomes

Number of continent men after 1 year (no leakage at all on 24 hour pad test)

12 months: 38/58; B 36/45

Adverse effects:

A 0/56; B 0/46

Quality of life

King’s Health Questionnaire (KHQ) (mean (SD) N):

General health

12 months: A 24.48 (50.7) 56; B 29.64 (50.7) 46

Role limitations

12 months: A 21.36 (22.2) 56; B 17.73 (22.2) 46

Physical limitations

12 months: A 16.49 (15.45) 56; B 13.48 (15.45) 46

Social limitations

12 months: A 7.98 (24.8) 56; B 4.15 (24.8) 46

Personal

12 months: A 18.72 (4.4) 56; B 19.62 (4.4) 46

Emotional

12 months: A 5.08 (7.0) 56; B 4.24 (7.0) 46

Sleep or energy disturbance: A 9.13 (39.0) 56; B 6.13 (39.0) 46

Symptom severity: A 14.62 (86.1) 56; B 10.93 (86.1) 46 

Notes

Trial was stopped early because interim analysis found no benefit for group A

Additional information supplied by author

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

“Computer‐generated random numbers with block randomization and variable block size”

Allocation concealment (selection bias)

Low risk

"central computer system"

Blinding of participants (performance bias)

Unclear risk

“participants were also blinded until their first visit to the pelvic floor physiotherapist”

Blinding of personnel (performance bias)

Low risk

“The pelvic floor physiotherapists were blinded to randomization” (to pre‐operative randomisation)

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Outcome assessor blinded

Incomplete outcome data (attrition bias)
All outcomes

Low risk

9 from A (1 unable to understand Dutch, 3 post‐operative radiotherapy, 1 oesophageal cancer, 3 discontinued intervention at own request, 1 excluded due to poor compliance) 8 from B (2 post‐operative radiotherapy, 1 pelvic lymph node dissection, 1 died of cause unrelated to prostate cancer, 5 discontinued intervention at own request, 1 prolonged catheter á demeure). Not differential dropout

Selective reporting (reporting bias)

Low risk

All outcomes in methods were reported

Financial support

Low risk

None

Approved by medical ethics committee

Low risk

“Medical ethical approval was obtained from the Medical Ethics committee of our university hospital”

Informed consent

Low risk

“Informed consent was obtained”

ITT analysis

Low risk

Assumed from flow diagram

Dubbelman 2004

Methods

Randomised: yes

Participants

Recruitment: post‐operative

Included: men incontinent post‐radical prostatectomy (≥ 1 g urine loss on 1 hour pad test), one week after catheter removal

Excluded: pre‐operative UI

N = 66 men completing the trial, 33 in intervention group, 33 in control

All participants had a radical retropubic prostatectomy and lived within 75 km of hospital

Age range 61 to 67 years

Interventions

Post‐operative intervention

A (35) intervention: 9 or less sessions of physiotherapy guided pelvic floor exercises after surgery plus information folder

B (44) control: exercise instruction through information folder only

Length of follow‐up: 6.5 months

Dropouts: A 1, B 2 due to stricture; + A 1, B 3 refused further measurements; + B 5 withdrew consent or 1 did not understand

Outcomes

Continence definition: incontinence defined as loss of at least 1 gram of urine on 1 hour pad test and 4 grams on the 24 hour pad test

Main outcome: urinary incontinence on both 1 hour (> 1 g) and 24 hour (> 4 g) pad tests

Secondary outcome: urodynamic study (urethral pressure profilometry)

Data collection: 1 and 26 weeks after catheter removal

Number of wet men at 6 months: A: 17/33, B: 20/33

No significance difference in continence rates between the groups

Notes

Sample size required 96 men in each arm

Other data presented as median (IQR)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random number generator to achieve 1:1 ratio

Allocation concealment (selection bias)

Low risk

Sealed envelopes, sequentially numbered, opened by trial nurse after result of pad test was known

Blinding of participants (performance bias)

High risk

Blinding to intervention not possible

Blinding of personnel (performance bias)

Unclear risk

"The physiotherapist who guided men in the PGPFME group was unaware of the outcome data of both treatment groups"

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

"The data for outcome assessment (e.g. pad‐tests, voiding diaries) were collected and entered in a data base by a trial nurse who was not involved in the treatment or intervention"

Incomplete outcome data (attrition bias)
All outcomes

High risk

13 dropped out (of which 2 from intervention group)

Selective reporting (reporting bias)

Low risk

All outcomes in methods reported

Financial support

Unclear risk

No description

Approved by medical ethics committee

Low risk

"approved by our institutional review board"

Informed consent

Low risk

"informed consent"

ITT analysis

Unclear risk

"the concept of an intent to treat analysis was not applied". Authors also state, "Participants were analysed in the group to which they were allocated at randomization"

Fader 2013

Methods

RCT Cross‐over design

Participants

Time of recruitment: post‐operative

Population: 74 men with incontinence after prostate surgery

Included: men who were experiencing incontinence more than a year after prostate cancer treatment and using absorbent pads

Excluded:  no description 

Age (mean, SD): no description

Dropouts: no information

Baseline characteristics: no information

Interventions

Time of intervention: post‐operative

A: penile compression device (clamp)  

B: sheath drainage system (sheath)

C: body‐worn urinals (BWU)

D: pads alone

All men tested each device for three weeks and asked to state which device was preferred

Duration of treatment: 3 weeks with each device

Follow‐up: 3 months

Outcomes

Primary outcome (number of men with UI)

Not reported

Other outcomes

Overall opinion: patient satisfaction questionnaire related to device performance

Asked to state which device they preferred:

Pads were most highly rated compared with sheaths (P = 0.31), clamps (P < 0.01) and BWUs (P < 0.001)

The clamp was rated as more secure, less leaky and less restrictive of clothing choice than the others (P < 0.05) but was more painful than the rest (P<0.002)

Three months later asked which products they were actually using and for what activities and circumstances:

30/56 using a combination of devices and pads

Quality of life

EORTC QLC C30

IIQ‐7

ICIQ‐UI

King's Health Questionnaire

Notes

Awaiting further information from author

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

“random order” cross‐over design

Allocation concealment (selection bias)

Unclear risk

“random order”

Blinding of participants (performance bias)

High risk

Blinding was not possible for participants

Blinding of personnel (performance bias)

Unclear risk

No description. Therefore judged to be unclear risk

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No description. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No information. Therefore judged to be unclear risk

Selective reporting (reporting bias)

High risk

Quality of life outcome not reported

Financial support

Low risk

Prostate Cancer UK

Approved by medical ethics committee

Low risk

Southampton and South West Hampshire Research Ethics Committee (REC)

Informed consent

Low risk

Yes

ITT analysis

Unclear risk

Not specified

Filocamo 2005

Methods

Randomised: yes
Method of allocation: block randomisation, block size of 4 for 2 groups (A and B) with only one permutation code (ABBA)

Blinding: not described
Dropouts: at 12 months, 2 participants dropped out of the control group
Intention to treat: yes

Participants

Recruitment: post‐operative

Included: all men undergoing RRP

N = 300 consecutive men post RRP, randomised after catheter removal to 2 groups
Intervention group: N = 150
Control group: N = 150

Interventions

Post‐operative intervention

Group A (150) intervention: formal instruction (3 treatment sessions plus at home exercises) in PFMT using verbal explanation, palpation and visualization of the base of the penis with a mirror, in different positions and prior to sneezing, coughing or lifting

Group B (150) control: no formal instruction

Length of follow‐up: 12 months

Outcomes

Main outcome: urine loss on 1 hour and 24 hour pad tests plus number of pads used daily

Continence definition: 0 to 1 pads per day

Data collection: 1, 3, 6, and 12 months

Wet (leakage or use of pads)

1 month: A 145/150, B 147/150

3 months: A 115/150, B 129/150

6 months: A 35/150, B 102/150

12 months: A 16/150, B 49/148

Surgical implantation of artificial urinary sphincter: A 2/150, B 3/148

Notes

74% of the intervention group achieved continence at 3 months compared to only 30% of the control (a significant difference favouring intervention)

Differences between the groups declined between 6 to 12 months, with most participants achieving continence in 1 year

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Block randomisation, block size of 4 for 2 groups (A and B) with only one permutation code (ABBA)

Allocation concealment (selection bias)

Unclear risk

Not stated. Therefore judged to be unclear risk

Blinding of participants (performance bias)

High risk

Blinding to intervention not possible

Blinding of personnel (performance bias)

High risk

Blinding to intervention not possible

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No description of blinding of pad test or data entry from questionnaires

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

2 dropped out of control group but none from intervention

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Unclear risk

Not reported. Therefore judged to be unclear risk

Approved by medical ethics committee

Low risk

"Approved by the Ethics Committee of our Institution"

Informed consent

Low risk

"All patients signed an informed consent form"

ITT analysis

Unclear risk

Not specified

Floratos 2002

Methods

Randomised: yes
Method of allocation: randomised 2:1 to intervention: control groups
Blinding: not mentioned
Dropouts: 1 participant randomised to intervention unable to follow intervention protocol (unable to attend clinic, provided with control invention)

Intention to treat: yes

Participants

Recruitment: post‐operative

Included: men incontinent post‐radical prostatectomy one week after catheter removal

N = 42 consecutive patients

Interventions

Post‐operative intervention

Group A (28) intervention: initiated after catheter removal. Intervention group received 15 treatment sessions (3 times per week for 30 minutes) of PFMT with EMG (surface) biofeedback in clinic

Group B (14) control: instruction with verbal feedback and an information pamphlet with instructions to perform PME 50 to 100 times daily at home

Length of follow‐up: 6 months

Outcomes

Main outcome: incontinence episodes measured by 1 hour pad test and continence questionnaire (pads used, number of incontinence episodes)

Continence definition: incontinence defined as a urine loss of > 1 g on the 1 hour pad test; 2 or more pads/day a not deemed a "socially acceptable continence rate"

Data collection: baseline, 1, 2, 3 and 6 months

Level of incontinence in both groups declined over the 6 months of the study. Control group had less urine loss and appeared to regain continence sooner, but the difference was not significant

Notes

Additional data supplied to KFH by author

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No description. Therefore judged to be unclear risk

Allocation concealment (selection bias)

Unclear risk

Randomised 2:1 to intervention: control groups

Blinding of participants (performance bias)

High risk

Blinding to intervention not possible

Blinding of personnel (performance bias)

High risk

Blinding to intervention not possible

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

High risk

1 dropped out of intervention group but followed control intervention ‐ unclear if analysed as control

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Unclear risk

Not reported. Therefore judged to be unclear risk

Approved by medical ethics committee

Unclear risk

Not reported. Therefore judged to be unclear risk

Informed consent

Low risk

"Patients were informed about the aims and perspectives of the study. Eligible patients consented"

ITT analysis

Unclear risk

"Analysed using the intention‐to‐treat approach". Authors also state "One of the patients initially randomized to group A could not follow the programme but performed PMEs under verbal instruction"

Fode 2014

Methods

RCT

Participants

Time of recruitment: pre‐operative

Population: 83 men undergoing nerve sparing radical prostatectomy (whole population, with or without UI)

Included: sexually active men with an IIEF score of at least 18 without aids, continent pre‐operatively

Excluded: condition that may prevent patient being able to have post‐operative treatment with PDE5‐inhibitor

Age (mean, range): A 62 (46‐73); B 65 (49 to 76)

Dropouts: 12 from group A (3 excluded because underwent non‐nerve sparing surgery, 2 withdrew consent, 1 lost a partner, 6 non‐compliance), 3 from group B (2 excluded because underwent non‐nerve sparing surgery, 1 withdrew consent). Differential dropout

Baseline characteristics: comparable except Group A significantly more LUTS pre‐operatively

Interventions

Time of intervention: pre‐operative + post‐operative

A (30): pre‐operative session guided PFMT + instruction on how to use penile vibratory stimulation device, instructed to stimulate frenulum once daily, 10 seconds of stimulation then 10 second pause, repeated 10 times for 1 week pre‐operatively, Instructed to restart stimulation after catheter removal for 6 weeks

B (38): pre‐operative session guided PFMT 

All men were offered a PDE5 inhibitor after 1 month post‐operatively and also received telephone contact to ensure compliance with treatment 

Duration of treatment:  6 weeks

Follow up: 3, 6 and 12 months post‐operatively

Outcomes

Primary outcome (number of men with UI)

Number of incontinent men (men reporting use of more than one pad daily)

3 months: A 14/42; B 15/41

6 months: A 7/42; B 3/41

12 months: A 3/30; B 2/38

(dropout figures added to 3 and 6 months) 

Other outcomes

Continence rate (patients reporting use of up to one pad daily for security reasons only)

3 months: A 65.5%; B 62.9%, P = 0.83

6 months : A 83.3%; B 91.9%, P = 0.28

12 months : A 90%; B 94.7%, P = 0.46

Median (range) pad use

3 months: A 1 (0 to 6); B 5 (0 to ‐34), P = 0.09

6 months: A 0 (0 to 3); B 1/3 (0 to 6), P = 0.14

12 months: A 0 (0 to 2); B 0 (0 to 3),  P = 0.56

Median (range) IIEF‐5

3 months : A 5 (0 to 25); B 5 (0‐25), P = 0.25

6 months : A 10.5 (0 to 25); B 5 (0‐25), P = 0.08

12 months : 18 (0 to 25); B 7.5 (0‐25), P = 0.09

IIEF ≥ 18, n/N (%)

3 months: 5/30 (17); B 4/38 (11), P = 0.46

6 months: 13/30 (43); B 9/38 (24), P = 0.09

12 months: 16/30 (53); B 12/38 (32), P = 0.07

Adverse effects: A: 5/30 reported side effects as a result of penile vibratory stimulation (1 red spots on glans penis, 1 small laceration + some bleeding, 2 complained of soreness, 1 frank pain post‐operatively)

B: 0/38

Quality of life

Median (range) DAN‐PSS post‐operatively

3 months: A 1 (0 to 34); B 5 (0‐34), P = 0.74

6 months: A 2 (0 to 41); B 1 (0‐48), P = 0.74

12 months: A 3 (0 to 36); B 0.5 (0‐21), P = 0.13

Notes

Further information provided by authors

PDE5 (phosphodiesterase yype 5) inhibitor is used for erectile dysfunction

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"randomized prospective trial" and “randomized by a draw”

Allocation concealment (selection bias)

Low risk

Used opaque sealed envelopes

Blinding of participants (performance bias)

High risk

“It was not possible to create a believable sham device, which could maintain blinding of the study subjects”

Blinding of personnel (performance bias)

Unclear risk

Not reported. Therefore judged to be unclear risk

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Outcome assessor not blinded

Incomplete outcome data (attrition bias)
All outcomes

High risk

12 from group A (3 excluded because underwent non‐nerve sparing surgery, 2 withdrew consent, 1 lost a partner, 6 non‐compliance), 3 from group B (2 excluded because underwent non‐nerve sparing surgery, 1 withdrew consent). Differential dropout

Selective reporting (reporting bias)

Low risk

Outcomes in methods reported

Financial support

Low risk

“This study was funded by unrestricted grants from the Velux Foundation and Grosserer L.F. Foghts Foundation”

Approved by medical ethics committee

Low risk

“The study was approved by the Danish ethical counsel and the Danish Data protection Agency”

Informed consent

Low risk

Assumed as they acquired ethical approval

ITT analysis

Low risk

Assumed from patient flow diagram

Franke 1998

Methods

Randomised: yes
Method of allocation: not stated
Blinding: none
Dropouts: 2 with gravitational incontinence consistent with intrinsic sphincter deficiency
Intention to treat: not clear

Participants

Recruitment: post‐operative

Included: men incontinence post‐radical prostatectomy at 6 weeks post surgery

N = 30 men: 6 weeks post‐radical prostatectomy with post‐void residual of < 50 ml; no previous TURP, no urinary tract infection, no neurological conditions

Interventions

Post‐operative intervention.

Group A (13): intervention, biofeedback (perineal patch EMG) enhanced PFMT; exercise treatment sessions at 6, 7, 9, 11, and 16 weeks post‐operatively

Group B (10): control, completed bladder diary but did not have any other intervention

Length of follow‐up: 12 months

Outcomes

Main outcome: urine loss measured by voiding diary, 48 hour pad test (reported as mean grams of urine lost in 24 hours), and incontinence questionnaire

Continence definition: not clear. Participants described as "completely dry" or with "significant incontinence"

Data collection: 6, 12 and 24 weeks

There were no significant differences between treatment or control groups on any of the outcome measures at any of the measurement intervals

Notes

Numbers in the groups unclear as 5 withdrew from the study after initial randomisation. Not clear how many were in each group prior to follow‐up at 6 weeks

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No description. Therefore judged to be unclear risk

Allocation concealment (selection bias)

Unclear risk

"Randomised"

Blinding of participants (performance bias)

High risk

Blinding not possible. Therefore judged to be at high risk

Blinding of personnel (performance bias)

Unclear risk

No description. Therefore judged to be unclear risk

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No description. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Five men withdrew after initial randomisation. Dropouts from 25 left at 6 weeks appears to be 10

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Low risk

None

Approved by medical ethics committee

Unclear risk

Not reported. Therefore judged to be unclear risk

Informed consent

Low risk

"Informed consent was obtained"

ITT analysis

Unclear risk

Not specified

Geraerts 2013

Methods

RCT

Participants

Time of recruitment: pre‐operative

Population: men having a radical prostatectomy (whole population, with or without UI)

Included: men planning to undergo open radical prostatectomy (ORP) or robot‐assisted laparoscopic radical prostatectomy (RARP)

Willing to accept ambulatory visits once a week until total continence was achieved; willing to perform measurements pre‐operatively and at 1 month, 3 months, 6 months and 12 months after surgery

Excluded:  cognitive problems; non‐Dutch speaking; simultaneous other surgery; transport problems; lack of time; psychosocial/other medical problems; refused participation; insisted on preoperative PFMT; not approachable; not enough time between diagnosis and date of planned surgery

Age (mean, SD): A 62 (5.90); B 62 (6.33)

Dropouts: 6 from A; (1 died, 1 cerebrovascular accident, 3 transport problems, 1 refused further participation) 4 from B: (2 transport problems, 2 refused further participation). Not differential dropout

Baseline characteristics: Comparable at baseline

Interventions

Time of intervention: pre‐operative

A (85): 30 mins of guided PFMT + biofeedback weekly for 3 weeks before surgery instructed to: carry out 60 contractions a day at home; contract their pelvic floor while coughing, and sitting down or getting up from a chair; restart PFMT on day 4 after surgery while catheter was in situ

 

B (85): instructed to start PFMT on the day after catheter removal (e.g. 2 to 3 weeks after surgery)

All men performed an individual guided exercise programme with digital or EMG biofeedback postoperatively weekly, delivered by a therapist (blinded to group allocation) different from the pre‐operative Group A therapist. This  included advice on using PF muscles to prevent leakage during functional activities

Duration of treatment: as long as any degree of UI persisted

Follow up: 1 month, 3 months, 6 months and 12 months after surgery

Outcomes

Primary outcome (number of men with UI)

Number of incontinent men (1 hour pad test defined as ≤ 1 g)

1 month: A 37/85; B 35/86, P = 0.758

3 months: A 15/86; B 15/86, P = 1.000

6 months: A 8/86; B 5/85, P = 0.566

12 months: A 7/81; B 7/83, P = 1.000

Other outcomes

Cumulative incidence of number of continent men

1 month: A 44/85; B 44/85

3 months: A 67/85; B 71/85

6 months: A 80/85; B 80/85

12 months: A 83/85; B 81/85

Point prevalence of continence, 1 hour pad test, defined as 0 g

1 month: A 42/85; B 41/86

3 months: A 63/86; B 61/86

6 months: A 76/86; B 73/85

12 months: A 68/81; B 73/83

Point prevalence of continence, VAS scale, defined as ≤ 1/10

1 month: A 35/89; B 38/88

3 months: A 64/88; B 52/87

6 months: A 73/88; B 65/86

12 months: A 72/84; B 62/84

Urine loss on 24 hour pad test in grams (mean (SD) N):

1 month: A 90 (?) 85; B 85 (?) 85

3 months: A 17 (?) 85; B 13 (?) 85

6 months: A 12 (?) 85; B 3 (?) 85 

12 months: A 2 (?) 85; B 3 (?) 85

Quality of life

International prostate Symptom Score (IPSS), King’s Health Questionnaire (KHQ): data not given

Only one aspect of the King’s Health Questionnaire, incontinence impact, favoured A at 3 (P = 0.008) and 6 months (P = 0.024) after surgery

Notes

Some men had pre‐operative incontinence

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Sequence of randomisation was carried out using a “computer program” and was “determined by the patients’ presence at the outpatient urology clinic”. It is unclear what influence the patients’ presence had on randomisation

Allocation concealment (selection bias)

Low risk

“Allocation to the treatment groups was concealed”. Method not reported

Blinding of participants (performance bias)

High risk

Blinding was not possible for participants

Blinding of personnel (performance bias)

Low risk

Post‐operative treatment was delivered by a therapist who was blinded to group allocation and treatment delivered by the pre‐operative Group A therapist 

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

“One blinded and well‐trained assessor performed the measurements”

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Dropouts: Group A: 6 (1 died, 1 cerebrovascular accident, 3 transport problems, 1 refused further participation); Group B: 4 (2 transport problems, 2 refused further participation)

Selective reporting (reporting bias)

High risk

Results not reported for quality of life outcomes

Financial support

Low risk

Unconditional funding from the “Agency for innovation by Science and Technology (Applied Biomedical Research): governmental grant”

Approved by medical ethics committee

Low risk

“Ethical approval from the commission on medical ethics of the University Hospitals Leuven”

Informed consent

Low risk

Patients “signed written informed consent”

ITT analysis

Low risk

“Data were analyzed according to the intention‐to‐treat principle”

Ghanem 2013

Methods

RCT

Participants

Time of recruitment: pre‐operative

Population: 100 men undergoing a radical prostatectomy (whole population, with or without UI)

Included: men undergoing RP for clinically localized prostate cancer.

Excluded: patients who had previous pelvic organ surgeries, patients with central or peripheral neurologic diseases  

Age (mean, SD): not reported  

Dropouts: not reported

Baseline characteristics: not reported

Interventions

Time of intervention: pre‐operative (post‐operative treatment for all men)

A (50): pre‐operative PFMT for 2 weeks + post‐operative PFMT programme      

B (50): post‐operative PFMT programme only

Duration of treatment

Follow‐up: 3.5, 4.5, 12, 13 and 13.5 months

Outcomes

Primary outcome (number of men with UI)

Number of incontinent men (defined as using > 1 pad on pad test)

12 months: A 2/50; B 3/50

13 months: A 2/50; B2/50

Other outcomes

Quality of life

ICS male SF questionnaire, results not reported

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

“Patients were divided randomly”

Allocation concealment (selection bias)

Unclear risk

Not reported. Therefore judged to be unclear risk

Blinding of participants (performance bias)

High risk

Blinding to treatment not possible

Blinding of personnel (performance bias)

Unclear risk

Not reported. Therefore judged to be unclear risk

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Not reported. Therefore judged to be unclear risk

Selective reporting (reporting bias)

Unclear risk

Protocol not available. Therefore judged to be unclear risk

Financial support

Low risk

None

Approved by medical ethics committee

Low risk

“Faculty of Physical Therapy Ethical committee, Cairo University”

Informed consent

Low risk

Yes

ITT analysis

Unclear risk

Not specified

Glazener RP 2011

Methods

RCT

Participants

Recruitment: post‐operative

Included: men with persistent urinary incontinence at 6 weeks after radical prostatectomy

Excluded: radiotherapy planned; unable to comply with study or intervention; previous formal PFMT

Age (mean, SD): A 62.4 (5.8); B 62.3 (5.6)

Interventions

A (205): one‐to‐one therapy sessions including PFMT and BT if OAB or urgency symptoms + PFMT and lifestyle leaflet

Duration of treatment: 4 sessions in 3 months starting 6 weeks after surgery

B (206): control group with standard care + lifestyle leaflet only, no individual PFMT instruction or sessions

Outcomes

UI defined as positive response to ICIQ‐SF questionnaire

UI at 3 months: A 172/200, B 176/198

UI at 6 months: A 158/197, B 158/197

UI at 9 months: A 144/191, B 157/194

UI at 12 months: A 148/196, B 151/195

Severe UI at 12 months: A 74/196, B 78/195

UI episodes at 12 months from diaries (mean (SD N): A 3 (3.8) 105, B 2.9 (3) 106

ICI‐Q score at 12 months (mean (SD N): A 4.9 (4.1) 196, B 5.4 (4.5) 195

QoL due to UI at 12 months (mean (SD N): A 1.4 (2) 193, B 1.7 (2.3) 193

Use of pads at 12 months: A 63/159, B 68/161

Men not doing PFMT at 12 months: A 63/191, B 91/189

Erectile dysfunction (no erection): A 105/189, B 105/190

QALYs virtually identical

Cost: NHS intervention cost was GBP 181 higher in intervention group (95% CI 107 to 255)

Other outcomes: use of other protection, catheters, sheath catheters, urinary frequency, nocturia, faecal incontinence, urgency, constipation, EQ5D, SF‐12

Notes

Low dropout rates

ICI‐Q score: 0 = no UI, no effect on QoL; 21 = maximum amount, frequency and effect on QoL

QoL due to UI measured using ICIQ‐SF: 0 = no effect, 10 = maximum effect

Compliance with therapy high

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated, minimised on centre, age and pre‐existing urinary incontinence

Allocation concealment (selection bias)

Low risk

Remote computer allocation

Blinding of participants (performance bias)

High risk

Blinding to intervention not possible for men

Blinding of personnel (performance bias)

High risk

Blinding to intervention not possible for therapists

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Outcomes from questionnaires completed by men, data entry clerks blinded to group

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No differential dropout from the groups

Selective reporting (reporting bias)

Low risk

Outcomes in methods were reported

Financial support

Low risk

"The trial was funded by the National Institute of Health Research Health Technology Assessment (NIHR HTA) Programme (project number 03‐14‐03) and will be published in full in Health Technology Assessment. HSRU, HERU, and NMAHP RU are funded by the Chief Scientist Office of the Scottish Government Health Directorates"

Approved by medical ethics committee

Low risk

"Our trials were approved by the Multicentre Research Ethics Committee, Edinburgh, Scotland and overseen by an independent trial steering committee and a separate independent data monitoring committee"

Informed consent

Low risk

"All men gave signed informed consent"

ITT analysis

Low risk

"We used intention‐to‐treat analysis"

Glazener TURP 2011

Methods

RCT

Participants

Recruitment: post‐operative

Included: men with persistent urinary incontinence at 6 weeks after transurethral resection of the prostate (TURP)

Excluded: radiotherapy planned; channel TURP for palliation for prostate cancer; unable to comply with study or intervention; previous formal PFMT

Age (mean, SD): A 68.2 (7.7); B 67.9 (8.1)

Interventions

A (220): one‐to‐one therapy sessions including PFMT and BT if OAB or urgency symptoms + PFMT and lifestyle leaflet

Duration of treatment: 4 sessions in 3 months starting 6 weeks after surgery

B (222): control group with standard care + lifestyle leaflet only, no individual PFMT instruction or sessions

Outcomes

UI defined as positive response to ICIQ‐short form questionnaire

UI at 3 months: A 142/205, B 132/208

UI at 6 months: A 140/199, B 129/201

UI at 9 months: A 133/197, B 131/202

UI at 12 months: A 126/194, B 125/203

Severe UI at 12 months: A 48/194, B 49/203

UI episodes at 12 months from diaries (mean (SD N): A 1.4 (2.3) 175, B 1.2 (2.2) 179

ICI‐Q score at 12 months (mean (SD N): A 3.9 (3.7) 194, B 4 (4.3) 203

QoL due to UI at 12 months (mean (SD N): A 1.2 (1.9) 190, B 1.3 (2.2) 199

Use of pads at 12 months: A 24/146, B 24/136

Men not doing PFMT at 12 months: A 66/188, B 154/193

Erectile dysfunction (no erection): A 52/177, B 43/178

QALYs virtually identical

Cost: NHS intervention cost was GBP 209 higher in intervention group (95% CI 147 to 271)

Other outcomes: use of other protection, catheters, sheath catheters, urinary frequency, nocturia, faecal incontinence, urgency, constipation, EQ5D, SF‐12

Notes

Low dropout rates

ICI‐Q score: 0= no UI, no effect on QoL; 21 = maximum amount, frequency and effect on QoL

QoL due to UI measured using ICIQ‐SF: 0 = no effect, 10 = maximum effect

Compliance with therapy high

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated, minimised on centre, age and pre‐existing urinary incontinence

Allocation concealment (selection bias)

Low risk

Remote computer allocation

Blinding of participants (performance bias)

High risk

Blinding to intervention not possible for men

Blinding of personnel (performance bias)

High risk

Blinding to intervention not possible for therapists

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Outcomes from questionnaires completed by men, data entry clerks blinded to group

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No differential dropout from the groups

Selective reporting (reporting bias)

Low risk

Outcomes in methods were reported

Financial support

Low risk

"The trial was funded by the National Institute of Health Research Health Technology Assessment (NIHR HTA) Programme (project number 03‐14‐03) and will be published in full in Health Technology Assessment. HSRU, HERU, and NMAHP RU are funded by the Chief Scientist Office of the Scottish Government Health Directorates"

Approved by medical ethics committee

Low risk

"Our trials were approved by the Multicentre Research Ethics Committee, Edinburgh, Scotland and overseen by an independent trial steering committee and a separate independent data monitoring committee"

Informed consent

Low risk

"All men gave signed informed consent"

ITT analysis

Low risk

"We used intention‐to‐treat analysis"

Goode 2009

Methods

Randomised controlled trial

Participants

Recruitment: post‐operative

Included: men incontinent 1 to 16 years after radical prostatectomy (mean years since operation: A 5.1, B 3.9, C 5.1)

N = 208 (prior to dropout). Analysis of 172 men at 8 weeks

Age between 51 to 84 years

% of men with prior PFMT instruction: A 36%, B 56%, C 47%

% of men using antimuscarinics: A 16%, B 20%, C 28%

% of men with urgency UI: A 1%, B 3%, C 2%

% of men with stress UI: A 44%, B 47%, C 44%

% of men with mixed UI: A 54%, B 50%, C 54%

Interventions

A (70): behavioural therapy with PFMT alone for 8 weeks

B (70): behavioural therapy with biofeedback and electrical stimulation for 8 weeks

C (68): control, no treatment for 8 weeks, then offered choice of intervention A or B

Behavioural therapy consisted of pelvic floor muscle exercises and bladder control strategies in both groups

Dropouts: A 19 at 6 months, 23 at 12 months; B 22 at 6 months, 36 at 12 months; C 3 at 8 weeks

Length of follow‐up: 12 months for groups A and B C transferred to treatment at 8 weeks so no further follow up possible

Outcomes

Frequency of UI, mean accidents in a week

Number of continent men at 8 weeks: A 11/70, B 12/70, C 4/68

Incontinence episodes per day at 8 weeks (mean, SD, N): A 1.86 (0.56) 58; B 1.71 (0.54) 54; C: 3 (1.17) 64

Change in quality of life at 8 weeks using EPIC UI subscale (bigger change is better, mean, SD, N): A 13.1 (15.5) 58; B 12.3 (14.6) 54; C 2.9 (12.4) 64

Adverse events: A 0/70, B 2/70 (haemorrhoidal irritation), C 0/68

Patient's Global Perceptions of Improvement (much better): A 90%, B 91%, C 10%

Completely satisfied with treatment progress: A 47%, B 47%, C not reported

Compliance with PFMT and bladder control strategies at 8 weeks: A 100%, B 93%

Compliance at 6 months: A 82%, B 84%

Compliance at 12 months: A 91%, B 81%

Notes

Some baseline differences between groups, did not quite reach statistical significance

High dropout rates

No data available for control group after eight weeks as all received treatment

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Stratified by site, type and frequency of UI, generated by computer programme

Allocation concealment (selection bias)

Low risk

Sealed envelopes, opened sequentially

Blinding of participants (performance bias)

High risk

Blinding to intervention not possible

Blinding of personnel (performance bias)

Unclear risk

Data entry staff blinded to group

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Outcomes from questionnaires completed by men, data entry staff blinded to group

Incomplete outcome data (attrition bias)
All outcomes

High risk

Analysis and reported tables on 172 men

Selective reporting (reporting bias)

Low risk

Results of outcomes reported

Financial support

Low risk

National Institutes of Health ‐ National Institute of Diabetes and Digestive and Kidney Diseases, grant R01 DK60044‐01A2

Approved by medical ethics committee

Low risk

Approved by "University of Alabama at Birmingham Institutional Review Board"

Informed consent

Low risk

Yes

ITT analysis

Unclear risk

Not specified

Hoffman 2005

Methods

Randomised: yes
Method of allocation: computerised randomisation
Blinding: unclear
Dropouts: 1 participant from each intervention group had dropped out by discharge; 15 dropouts from the perineal group, 31 from the anal group and 5 from the control group dropped out by 3 months
Intention to treat: no

Participants

Recruitment: post‐operative

Included: men incontinent post‐radical prostatectomy in an inpatient rehabilitation program

N= 180 men (prior to dropouts). Randomly assigned to 3 groups (60 in each group)

Interventions

Post‐operative intervention
Group A (60) intervention: perineal ES plus physiotherapy (PFMT)

Group B (60) intervention: anal ES plus physiotherapy (PFMT)

Group C (60) control: PFMT alone.

Length of follow‐up: 3 months

Outcomes

Main outcome: urine loss measure on 1 hour pad test

Secondary outcomes: quality of life (QLQ‐C30)

Continence definition: self‐reports of incontinence

Data collection: admission and discharge from the rehabilitation program and at 3 months after discharge

All groups improved on continence and quality of life. Use of ES was only of additional value in a compliant subgroup. Perineal ES was better accepted than anal

Notes

Additional data supplied to KFH by author

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Computerised randomisation

Allocation concealment (selection bias)

Unclear risk

Method of allocation concealment not specified

Blinding of participants (performance bias)

Unclear risk

Insufficient information to permit judgement

Blinding of personnel (performance bias)

Unclear risk

Insufficient information to permit judgement

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Insufficient information to permit judgement

Incomplete outcome data (attrition bias)
All outcomes

High risk

Dropouts: 22 out of 60 in anal ES group, 4 out of 60 in perineal ES group. No reasons for dropouts given

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Unclear risk

Not reported. Therefore judged to be unclear risk

Approved by medical ethics committee

Unclear risk

Not reported. Therefore judged to be unclear risk

Informed consent

Unclear risk

Not reported. Therefore judged to be unclear risk

ITT analysis

High risk

No intention‐to‐treat analysis; insufficient information on methods of statistical analysis; interventions unclear and insufficiently specified

Hou 2013

Methods

RCT

Participants

Time of recruitment: pre‐operative

Population: 66 men who underwent TURP (whole population, with or without UI)

Included: patients with benign prostatic hyperplasia and underwent TURP, aged 60 to 90 years, remarkable lower urinary tract symptoms (LUTS) with poor response to medication, ambulatory, able to communicate verbally

Excluded: indwelling catheter‐dependent postdischarge, neurogenic bladder, dementia or disability affecting verbal communication

Age (mean, SD): A  69.67 (6.09); B 71.41 (6.67)

Dropouts: 5 (2 catheter still in situ after discharge from hospital, 3 lost to follow‐up). Not differential dropout

Baseline characteristics: comparable at baseline

Interventions

Time of intervention: post‐operative treatment

A (32): guided PFMT + EMG biofeedback after catheter removal (2 days postoperatively), instructed to: contract pelvic muscles for 5 seconds and relax for 10 seconds. After discharge, patients were instructed to carry out 5 mins of each PFE three times daily. Patients also received motivational telephone interviews once weekly

B (29): no description

Duration of treatment: 12 weeks

Follow up: 1 week, 1 month, 2 months and 3 months

Outcomes

Primary outcome (number of men with UI)

Not reported

Other outcomes

Quality of life

SF‐36 scores (mean (SD) N)

Physical component

3 months: A 54.86 (8.62) 32; B 49.86 (11.23) 29

Physical functioning

3 months: A 89.69 (17.13) 32; B 85.82 (21.60) 29

Body pain

3 months: A 93.66 (15.16) 32; B 89.48 (22.71) 29

General health

3 months: A 82.03 (14.05) 32; B 64.93 (27.16) 29

Physical role limitation

3 months: A 68.75 (36.48) 32; B 51.72 (38.92) 29

Mental health component

3 months: A 56.21 (6.20) 32; B 48.52 (11.94) 29

Mental role limitation

3 months: A 93.75 (21.48) 32; B 73.81 (37.80) 29

Vitality

3 months: A 80.47 (13.16) 32; B 64.14 (24.02) 29

Mental health

3 months: A 88.00 (10.51) 32; B 77.38 (18.68) 29

Social functioning

3 months: A 90.63 (14.20) 32; B 76.29 (29.57) 29

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"randomly classified"

Allocation concealment (selection bias)

Unclear risk

"randomly classified"

Blinding of participants (performance bias)

High risk

Blinding to intervention was not possible

Blinding of personnel (performance bias)

High risk

Blinding not possible

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

5 (2 catheter still in situ after discharge from hospital, 3 lost to follow‐up). Not differential dropout

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Unclear risk

Not reported. Therefore judged to be unclear risk

Approved by medical ethics committee

Unclear risk

Not reported. Therefore judged to be unclear risk

Informed consent

Unclear risk

Not reported. Therefore judged to be unclear risk

ITT analysis

Unclear risk

Not reported. Therefore judged to be unclear risk

Joseph 2000

Methods

Randomisation: yes
Method of allocation: not described
Blinding: none
Dropouts: 3 did not return to clinic for all appointments, one had other health problems
Intention to treat: no

Participants

Recruitment: post‐operative

Included: men incontinent post‐radical prostatectomy or post‐TURP. UI of at least 6 months duration

N = 11 patients at least 6 months post‐surgery (4 radical retropubic, 6 radical peritoneal, 1 TURP)

Interventions

Post‐operative intervention

Group A (6): intervention: Instruction in PFMT including biofeedback with visual feedback as well as verbal to assist in identifying and discriminating muscles

Group B (5): comparator: Instruction in PFMT, squeezing of finger during digital rectal examination

Both: weekly visit for a total of 4 clinic visits

Length of follow‐up: 12 months

Outcomes

Main outcome: urine loss measure by standardised pad test, bladder diary, subjective estimation of degree of incontinence

Secondary outcomes: leak point pressure measured by video‐urodynamics, Joseph Continence Assessment Tool

Continence definition: subjective evaluation by participants

Data collection: baseline, 3, 6, and 12 months

No differences between the groups. Improvement seen in all patients at 12 months

Notes

Data not published in article. Raw data supplied to review author (KFH) who calculated means and standard deviations. These were reviewed by a second review author (KNM)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No description. Therefore judged to be unclear risk

Allocation concealment (selection bias)

Unclear risk

Reported as "Randomised". No additional information provided

Blinding of participants (performance bias)

High risk

Blinding to intervention not possible

Blinding of personnel (performance bias)

High risk

Blinding to intervention not possible

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported. Therefore judged to be unclear risk.\

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Three dropouts

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Unclear risk

Not reported. Therefore judged to be unclear risk

Approved by medical ethics committee

Unclear risk

Not reported. Therefore judged to be unclear risk

Informed consent

Unclear risk

Not reported. Therefore judged to be unclear risk

ITT analysis

High risk

No

Koo 2009

Methods

Randomised: yes

Participants

Recruitment: post‐operative

Included: men with UI after radical prostatectomy

Randomised: N = 32

Interventions

A (16) intervention: extra‐corporeal magnetic innervation (ExMI), treatment sessions were for 20 minutes twice weekly for 8 weeks

B (16) control: PFMT alone. Duration of treatment not specified

Length of follow‐up: six months

Outcomes

24 hour pad test, g of urine

Baseline: A 655, B 646

1 month: A 147, B 187

2 months: A 33, B 81, P = 0.001

3 months: A 9 (SD 28), B 45 (28), P = 0.001

6 months: Less than 10 g in both groups

Number of pads used daily

Baseline: A 4.2, B 4.1

I month: A 1.5, B 1.8

2months: A 0.6, B 0.9, P = 0.033

3 months: A 0.1 (0.42), B 0.6 (0.42), P = 0.002

6 months: A 0, B 0.1

Quality of life measured by I‐QoL

Notes

Awaiting further translation ‐ information from abstract only

SDs calculated using P values

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No description, Chinese language

Allocation concealment (selection bias)

Unclear risk

"Randomly assigned"

Blinding of participants (performance bias)

Unclear risk

No description. Therefore judged to be unclear risk

Blinding of personnel (performance bias)

Unclear risk

No description. Therefore judged to be unclear risk

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No description. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No description Therefore judged to be unclear risk

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Unclear risk

Not reported, Chinese language

Approved by medical ethics committee

Unclear risk

Not reported. Therefore judged to be unclear risk

Informed consent

Unclear risk

Not reported. Therefore judged to be unclear risk

ITT analysis

Unclear risk

Not reported. Therefore judged to be unclear risk

Laurienzo 2013

Methods

RCT

Participants

Time of recruitment: pre‐operative

Population: men having a radical prostatectomy (whole population, with or without UI)

Included: patients with prostate cancer (stage T2) and candidates for RPP who were referred for treatment

Excluded: radiotherapy (previous or after RPP), previous transurethral resection, pre‐existing neurological disease, urinary fistula after RPP, prolonged indwelling urethral catheterization (more than 15 days), clinical situations that rendered the patient unsuitable for surgical procedure, failure to attend all PFMR or electrical stimulation sessions, loss of follow‐up and desistance  

Age (mean, SD): A 64 (8); B 62 (7); C 60 (8)

Dropouts: 9 (2 failed to attend all sessions, 2 desistance, 1 adjuvant radiotherapy, 1 postoperative urethral stenosis, 1 urinary fistula, 1 unsuitable for surgery due to cardiovascular risk, 1 inadequate follow up) Unclear from which group

Baseline characteristics: Comparable at baseline

Interventions

Time of intervention: pre‐operative only

A (15): standard treatment with verbal instructions for PFMT

B (17): pre‐operative guided PFMT, with 10 physiotherapy sessions: contractions of the pelvic floor muscles for 5 seconds in “dorsal decubitus” position for 10 times, in the same position with the waist elevated (10 times), lying down with legs adducted against a plastic ball performed 10 times and standing and flexing the hips to 60̊ (10 times) 

C (17): pre‐operative PFMT + electrical stimulation during 10 physiotherapy sessions, electrical stimulation was with an anal probe lasting 15 minutes in total, and men also received guided PFMT and followed the same training regime as above

Men did not receive PFMT post‐operatively

 

Duration of treatment: 10 pre‐operative sessions 

Follow up: 1, 3 and 6 months

Outcomes

Primary outcome (number of men with UI)

Not reported

Other outcomes

1 hour pad test score (mean (SD) N)

1 month: A 17.6 (38.5) 15; B 29.5 (35.8) 17; C 25.5 (35.4) 17

3 months:14.3 (34.4) 15; B 11.8 (28.4) 17; C 9.6 (18.8) 17

6 months: A 5.5 (14.16) 15; B 25.3 (59) 17; 4.35 (7.3) 17

Quality of life

ICIQ‐SF score (mean (SD) N)

1 month: A 7.5 (5) 15; B 14 (3.6) 17; C 9.6 (6.3) 17

3 months: A 5.4 (5.2) 15; B 6.9 (5.8) 17; C 7.2 (6.4) 17

6 months: A 3.7 (5.3) 15; B 4.8 (5.3) 17; C 5.3 (5.5) 17

SF‐36

Results not reported: “There were no differences between groups on the various domains of the SF‐36 (p > 0.05)”

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

“The patients were randomized (computer generated list using Randomizer, v4)”

Allocation concealment (selection bias)

Unclear risk

“The patients were randomized (computer generated list using Randomizer, v4)”

Blinding of participants (performance bias)

High risk

Blinding to intervention not possible

Blinding of personnel (performance bias)

Unclear risk

“PFMR was performed in the preoperative period by the same physiotherapist.”

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No information. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

9 (2 failed to attend all sessions, 2 desistance, 1 adjuvant radiotherapy, 1 post‐operative urethral stenosis, 1 urinary fistula, 1 unsuitable for surgery due to cardiovascular risk, 1 inadequate follow‐up). Unclear from which group

Selective reporting (reporting bias)

High risk

Results of SF‐36 not reported

Financial support

Low risk

“Sao Paulo State Foundation for Research Support – FAPESP (number 08/54585‐1)” 

Approved by medical ethics committee

Low risk

“After approval by the ethical committee and internal review board, 58 consecutive males were included in this analysis”

Informed consent

Low risk

“All subjects received and signed an informed consent form”

ITT analysis

Low risk

Data presented for all men randomised and not excluded. No differential dropout apparent

Liu 2008

Methods

Randomised controlled clinical trial

Participants

Recruitment: post‐operative

Included: men with UI after radical prostatectomy

Randomised: N = 24

Interventions

Group A (12) intervention: extra‐corporeal magnetic innervation (ExMI), the frequency of the pulse field was 10 Hz for 10 minutes, followed by a 3 minute rest and a second treatment of 50 Hz for 20 minutes. This was done twice a week

Group B (12) control: PFMT alone, instructions given to carry out 20 mins x 3 a day

Duration of treatment: six weeks

Length of follow up: 1, 3 and 6 months

Outcomes

Main outcome measures: quality of life scale and the ICI‐Q‐SF

1 month: both scores were decreased with no significant differences between the groups

At 3 and 6 months: both scores decreased with group A having a significantly lower (better) score than group B (P < 0.05)

Notes

Information from abstract, awaiting translation of paper

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote "randomly assigned". No additional information provided

Allocation concealment (selection bias)

Unclear risk

No description. Therefore judged to be unclear risk

Blinding of participants (performance bias)

High risk

Blinding not possible

Blinding of personnel (performance bias)

High risk

Blinding not possible

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All 24 patients included in the final analysis

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Unclear risk

Not reported. Therefore judged to be unclear risk

Approved by medical ethics committee

Low risk

Hospital board, local military university hospital

Informed consent

Unclear risk

Not reported. Therefore judged to be unclear risk

ITT analysis

Unclear risk

Not specified. Therefore judged to be unclear risk

Manassero 2007

Methods

Randomised: prospective randomised controlled trial

Method of allocation: computer generated random numbers

Blinding: blinded outcome assessors, not instructors

Dropouts: 12 excluded as the couldn't attend regularly for PFMT; 33 continent after surgery and were not randomised; 13 lost to follow‐up in the control group (5 social reasons and 8 non‐responders)

Intention to treat: no

Participants

Recruitment: post‐operative

Included: men incontinent (UI > 2g/24 hour pad test), post‐radical prostatectomy who were able to attend hospital

Excluded: those with a history of preoperative incontinence, significant perioperative complications, rectal lesion, infection, psychiatric neurological disorders, inability to contract PF muscles or weak contraction with increased detrusor activity

Mean age: A 66.8 (6.3 years), B 67.9 (5.5 years)

Interventions

Group A (54) intervention: PFMT re‐education program, verbal feedback

The training program involved active PFE. Verbal feedback of the contraction was used to instruct the patients to correctly and selectively contract their pelvic muscles while relaxing the abdominal muscles. The strength of the pelvic floor muscles was measured by digital anal control using a score of 0 to 5 ( 0 = no contraction, 5 = good contraction against strong resistance)

Initially home practice comprised 45 contractions (3 sessions of 15) per day at home, progressively increasing the number until 90 per day. This was taught by two experienced urologists

Group B (53) control: no treatment

Duration of treatment: up to a year or until incontinence ceased

Length of follow‐up: 1, 3, 6 and 12 months

Outcomes

UI at ‐

1 month: A 83.3% (45/54), B 97.5% (39/40), P = 0.04

3 months: A 53.7% (29/54), B 77.5% (31/40), P = 0.03

6 months: A 33.3% (18/54), B 60% (24/40), P = 0.01

12 months: A 16.6% (9/54), B 52.5% (21/40), P < 0.01

Subjective assessment of continence using VAS: P = 0.01 at 12 months

Quality of lIfe (single question): P = 0.03 at 12 months

Notes

ITT analysis used for data entry, assuming that all 13 men who dropped out of the control group were dry, because of differential dropout of 13 men from B versus none from A with no explanation for difference between groups

If unable to contract anal sphincter or strength 2 or less, not randomised. These men were given ES treatment at home with anal probe

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated random numbers

Allocation concealment (selection bias)

Low risk

Stratified on volume of urine lost on pad test

Blinding of participants (performance bias)

High risk

Blinding of intervention not possible

Blinding of personnel (performance bias)

High risk

Blinidng of intervention not possible

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Blinded outcome assessors

Incomplete outcome data (attrition bias)
All outcomes

High risk

Differential dropout of 13 from control group, ITT analysis used for data entry by review authors

Selective reporting (reporting bias)

Unclear risk

Outcomes in methods reported

Financial support

Unclear risk

Not reported. Therefore judged to be unclear risk

Approved by medical ethics committee

Low risk

"The study was approved by the Medical Centre Institutional Review Board"

Informed consent

Low risk

"All men provided informed consent"

ITT analysis

Low risk

Assumed from patient flow chart

Marchiori 2010

Methods

RCT

Participants

Time of recruitment: post‐operative

Population: men with incontinence after retropubic radical prostatectomy, open or laparoscopic

Included: moderate to severe incontinence at 30 days after catheter removal

Excluded: lack of cooperation, pre‐operative incontinence, early recovery of continence

Age (mean): A 67; B 66.5

Dropouts: “Survey questionnaire were correctly filled in and returned by fewer than 10% of the patients”

Baseline characteristics: comparable at baseline

Interventions

Time of intervention: post‐operative treatment

A (166): one‐to‐one guided PFMT + biofeedback during first session, second session involved 10 sets of pelvic floor electrical stimulation lasting 15 mins each, instructed to: carry out three sets of 30 contractions a day at home for the first month after catheter removal (16 days after surgery)

B (166): received oral and written information on pelvic floor anatomy and on PFME, instructed to: perform three sets of 30 contractions a day at home for the first month after catheter removal (16 days after surgery) and continue for duration of

All men received oral and written information on pelvic floor anatomy and on PFME, pelvic floor muscle endurance assessed by digital anal control + PFMT consisting of 3 sets of 30 contractions daily for the first month after catheter removal

Duration of treatment

Follow up: 3 months, 6 months and 12 months

Outcomes

Primary outcome (number of men with UI)

Number of incontinent men (defined as 0 or 2 minipads daily)

3 months: A 36/166; B 81/166

6.5 months: A 1/166; B 28/166

12 months: A 0/166; B 0/166

Other outcomes

Median time of continence recovery, days:

A 44 ± 2, B 76 ± 4, P ≤ 0.01

Quality of life

ICIQ‐male: Results not reported

RAND 36‐Item Health Survey questionnaire: results not reported

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

“Prospectively randomized” Sequence generation not reported

Allocation concealment (selection bias)

Unclear risk

"Prospectively randomized"

Blinding of participants (performance bias)

High risk

Blinding to intervention not possible

Blinding of personnel (performance bias)

High risk

Blinding to intervention not possible

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

High risk

Not reported for primary outcome

Selective reporting (reporting bias)

High risk

No reporting of primary outcome

Financial support

Unclear risk

Not reported. Therefore judged to be unclear risk

Approved by medical ethics committee

Unclear risk

Not reported. Therefore judged to be unclear risk

Informed consent

Unclear risk

Not reported. Therefore judged to be unclear risk

ITT analysis

Unclear risk

Not reported. Therefore judged to be unclear risk

Mariotti 2009

Methods

Randomised: yes

Participants

Randomised post‐operatively

Included: radical prostatectomy, all men after catheter removal

Age: Group A mean 61.86 years, Group B, 61.43 years

Interventions

Intervention post‐operative

Group A (30) intervention: PFMT plus ES and biofeedback twice a week for 6 weeks

ES ‐ a surface electrode was inserted into the anus and pulsed, the intensity was adequate to induce visual lifting of the levator ani and pubococcygeus muscle, considering the level of comfort to the patient

Biofeedback ‐ via surface electrodes both perineal and abdominally

Group B (30) control: instructions to conduct PFMT ‐ verbal and written instructions at catheter removal and follow‐up visits

Duration of treatment: 6 weeks

Length of follow up: 3 and 6 months

Outcomes

24 hour pad test: g/24hrs, mean (SD)

3 months: A 16.67 (30.55), B 136.67 (152.62), P = 0.000

6 months: A 3.47 (14.67), B 27.83 (55.98), P = 0.0004

ICS‐male questionnaire, number of men incontinent, n/N

3 months: A 6/30, B 20/30

6 months: A 1/30, B 10/30

Time to regain continence: A 8 (6.49) weeks, B 13.88 (8.32) weeks, P = 0.003

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Consecutive patients

Allocation concealment (selection bias)

Unclear risk

Quote ‐ "Randomized fashion"

Blinding of participants (performance bias)

High risk

Blinding not possible

Blinding of personnel (performance bias)

Unclear risk

No description. Therefore judged to be unclear risk

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No dropouts

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Unclear risk

Not reported. Therefore judged to be unclear risk

Approved by medical ethics committee

Unclear risk

Not reported. Therefore judged to be unclear risk

Informed consent

Low risk

"All patients signed an informed consent before randomization"

ITT analysis

Unclear risk

Not specified. Therefore judged to be unclear risk

Martini 2011

Methods

RCT (abstract only)

Participants

Time of recruitment: pre‐operative

Population: 70 consecutive men undergoing a laparoscopic radical prostatectomy (whole population, with or without UI)

Included: men undergoing RP for clinically localized prostate cancer T1 to T3

Excluded: history of incontinence or overactive bladder, central or peripheral neurologic disease and cognitive impairment

Age (mean, SD): not reported  

Dropouts: 5 lost to follow up, unclear from which group

Baseline characteristics: not reported

Interventions

Time of intervention: pre‐operative (post‐operative treatment for all men)

A (24): PFMT:  5 sessions of guided PFMT for 2 to 3 weeks pre‐operatively and continued post‐operatively

B (25): post‐operative standard care, written instructions for PFMT

All men underwent clinical examination of pelvic muscles function using digital perineal testing according to “AIPDA score” and evaluation of voiding symptoms

Duration of treatment: 

Follow up: 1, 3 and 6 months

Outcomes

Primary outcome (number of men with UI)

Number of incontinent men (need to wear a pad)

No useable data

Other outcomes

24 hour pad test

Pad use

Bladder diary

Quality of life

Instrument unspecified

Notes

No useable data

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

“randomised”

Allocation concealment (selection bias)

Unclear risk

Not reported. Therefore judged to be unclear risk

Blinding of participants (performance bias)

High risk

Blinding to treatment not possible

Blinding of personnel (performance bias)

Unclear risk

Not reported. Therefore judged to be unclear risk

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

“Five patients lost at follow up”. Not clear why there were dropouts or from which group

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Unclear risk

Not reported. Therefore judged to be unclear risk

Approved by medical ethics committee

Unclear risk

Not reported. Therefore judged to be unclear risk

Informed consent

Unclear risk

Not reported. Therefore judged to be unclear risk

ITT analysis

Unclear risk

Not specified. Therefore judged to be unclear risk

Mathewson‐Chapman 97

Methods

Randomised: yes, block procedure
Method of allocation: not reported
Blinding: none
Dropouts: 2, not accounted for
Intention to treat: not clear

Participants

Recruitment: pre‐operative

Included: all men undergoing radical prostatectomy

N = 53 men
Randomised pre‐operatively

Interventions

Pre and post‐operative intervention

Group A (27) intervention: pre‐operatively received further instruction and practice with PME protocol home exercises and biofeedback (anal probe) (Incare 8900); practiced at home 3 times a week, starting with daily 15 PFMT and increasing by 10 every 4 weeks to a maximum of 35 PFMT

Group B (24) control: post‐operatively no further interventions until week 5 when pelvic muscle strength was assessed

Both: pre‐operatively, both groups received 30 minutes' prostate education programme and baseline 'perineal muscle evaluation' (not defined); as well all were taught to contract the perineal muscle and hold for a few seconds prior to standing, lifting or coughing and limit the amount of tea, chocolate, alcohol and over‐the‐counter medications

Length of follow‐up: 12 weeks

Outcomes

Main outcome: urine loss measured by 24 hour pad test, frequency of micturitions (self‐recorded bladder diary), number of pads used; days to achieve continence from baseline

Secondary outcomes: perineal muscle strength (method not described)

Continence definition: self‐report of return of continence

Data collection: 3 day bladder diaries at weeks 2, 5, 9 and 12. 24 hour pad test at weeks 5 and 12

Notes

Inclusion of other modalities such as caffeine limitation and using perineal muscles during any event which increased abdominal stress may have masked any treatment benefit

Extra information obtained from thesis

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Block procedure

Allocation concealment (selection bias)

Unclear risk

No description. Therefore judged to be unclear risk

Blinding of participants (performance bias)

High risk

Blinding to intervention not possible

Blinding of personnel (performance bias)

Unclear risk

No description. Therefore judged to be unclear risk

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No description. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Two dropouts

Selective reporting (reporting bias)

Low risk

Outcomes in methods reported

Financial support

Unclear risk

Not reported

Approved by medical ethics committee

Low risk

"Permission to conduct this study was obtained from the Univerisity of Florida Health Center Institutional Review Board (IRB)."

Informed consent

Low risk

"The informed consent was explained to each subject, and his signature was obtained to confirm consent to participate in the study"

ITT analysis

Unclear risk

Not specified. Therefore judged to be unclear risk

Moore 1999

Methods

Randomised: yes
Method of allocation: sealed envelopes

Blinding: physiotherapist blinded to results of control group
Dropouts: 5

Participants

Recruitment: post‐operative

Included: men incontinent post‐radical prostatectomy. Median duration of UI 8 weeks post‐surgery, range 4 to 200 weeks

N = 63 men (53 completed study)
Randomised to 3 groups

Interventions

Post‐operative intervention

Intervention
Group A (18) intervention: PFMT alone
Group B (19) intervention: PFMT plus rectal electrical stimulation treated by one physiotherapist 30 minutes twice a week for 12 weeks
Intervention groups also did home exercises 3 times/day gradually working up to 30 minutes per session lying, standing, sitting; strength, endurance, speed and control with maximum contractions of 5 to 10 seconds, 10 to 20 second relaxation and 12 to 20 repetitions; submaximum contractions at 65% to 75% of maximum strength with hold 20 to 30 seconds and equal rest time, 8 to 10 repetitions; speed was sets of quick repetitive contractions in a 10 second time span; control involved gradual recruitment to maximum contraction in 3 stages with 5 second hold at each stage and a slow release with rest 15 to 30 seconds

Group C (21) control: oral and written information about PFMT pre and post‐operatively (standard treatment)

Length of follow‐up: 24 weeks

Outcomes

Main outcome: urine loss measured by 24 hour pad test

Secondary outcomes: quality of life measures (Incontinence Impact Questionnaire, European Organization for the research and treatment of Cancer‐EORTC QLQ C‐30, version 2), physical symptom inventory (adapted from Herr 1994)

Continence definition: ≤ 2 g urine/24 hours

Data collection: baseline, 12, 16, 24 weeks after baseline

Notes

Intervention perhaps administered too early ‐ all subjects improved at the same rate; wide range of severity of urinary incontinence at study entry and size of SD of pad test results also may have resulted in Type II error

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Participants were assigned using a computer‐generated random‐number list placed in sealed envelopes at the end of the assessment visit, with patient and researcher opening the sealed envelope"

Allocation concealment (selection bias)

Low risk

"Participants were assigned using a computer‐generated random‐number list placed in sealed envelopes at the end of the assessment visit, with patient and researcher opening the sealed envelope"

Blinding of participants (performance bias)

High risk

Blinding to intervention not possible

Blinding of personnel (performance bias)

Low risk

Physiotherapist blinded

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

5 (3 from group B, 2 from group A), 3 bladder neck contractures, 1 rectal pain when performing exercises, 1 vacation for 4 months). No differential dropout

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Low risk

"Funding for the research project was received from the Oncology Nurses' Society, Canadian Nurses' Foundation, Caritas Health, Alberta Physiotherapy Association, Edna Minton Foundation, and the University of Alberta"

Approved by medical ethics committee

Low risk

"approved by the University of Alberta and Caritas Health Group ethics review boards"

Informed consent

Low risk

"All patients signed informed consent"

ITT analysis

High risk

Intention‐to‐treat‐analysis not performed

Moore 2004

Methods

Randomised: yes (order of product testing: in threes to treatment block of 4 periods (1 no device, 3 with devices)
Block, multiple period cross‐over design using Latin square configuration
Method of allocation: sealed envelopes. Blinding: research assistant not involved in study chose envelope; but research assistant and participants could not be blinded to intervention

Dropouts: none
Intention to treat: not discussed

Participants

Recruitment: post‐operative

Included: men incontinent post‐radical prostatectomy who required continuous pad protection for stress incontinence

Inclusion criteria: normal perineal and penile sensation, intact penile skin, sufficient manual dexterity
Exclusion criteria: overactive bladder, neurological disorders affecting sensation or circulation, cognitive impairment.

N = 12 men

Interventions

Post‐operative intervention

Each participant had 4 periods (each lasted 1 day)
Group A: no device
Group B: C3 device
Group C: U‐Tex device
Group D: Cunningham clamp

Outcomes

Main outcome: 4 hour pad test

Secondary outcomes: resistive index, cavernosal flow

None of the devices completely eliminated urine loss when applied at a comfortable pressure. Each device showed improvement in terms of urine lost, with Cunningham clamp having the lowest mean loss
Cunningham clamp significantly lowered flow, but ranked positively by participants

Notes

Unable to blind participants and research assistant to intervention
Sample size calculation given and required size achieved

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"A computer‐generated randomized list of device assignments was prepared by one of the investigators" Block, multiple period crossover design using Latin square configuration

Allocation concealment (selection bias)

Low risk

Sealed envelopes, research assistant not involved in study chose envelope

Blinding of participants (performance bias)

High risk

Blinding to intervention not possible

Blinding of personnel (performance bias)

High risk

Blinding to intervention not possible

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

"A research assistant not directly involved with recruitment or data collection entered the data"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No dropouts

Selective reporting (reporting bias)

Low risk

Outcomes reported

Financial support

Low risk

"This study was supported by the University of Alberta Internal Allocations Fund and Department of Radiology, University of Alberta Hospital."

Approved by medical ethics committee

Low risk

"The Institutional review Board at the University of Alberta approved the study"

Informed consent

Low risk

"the study was explained and informed consent obtained"

ITT analysis

Unclear risk

Not specified. Therefore judged to be unclear risk

Moore 2008

Methods

Randomised: yes
Method of allocation: computer generated list of numbers; group allocation placed in sealed opaque envelopes; opened by subject after initial post‐operation instruction session with therapist
Blinding: data entry by clerk blinded to group; therapist blinded to outcome of non‐intervention group; pads weighed by third party
Dropouts: control = 7; treatment = 12

Participants

Recruitment: post‐operative (but approached before surgery)

Included: men incontinent after radical prostatectomy (> 8 grams urine lost on 24 hour pad test) at 4 weeks post‐surgery

N = 217 men from 3 centres with early stage prostate cancer
Inclusion criteria: English speaking, living within 1 hour drive of research centre

Interventions

Post‐operative intervention

Group A (106) intervention: maximum 24 weekly, 30 minute treatment protocol (30 min biofeedback‐assisted PFMT) and home exercise protocol of 2 to 3 times a day

Group B (99) control: verbal and written information on PFME and weekly telephone contact by a urology nurse

Both: at 4 weeks post‐surgery, both groups received standardised verbal and written instruction about PFMT and recovery after radical prostatectomy by one dedicated physiotherapist or registered nurse at each site

Length of follow‐up: 12 months

Outcomes

Main outcome: grams of urine loss on 24 hour pad test (> 8 g defined as incontinence)

Definition of continence: < 8 g of urine loss on 24 hour pad test; subjective continence defined as yes or no

Secondary outcome: IPSS, IIQ‐7 (Incontinence Impact Questionnaire), voiding diary, and subjective continence

All measures obtained at baseline (pre‐operatively) and at 4, 8, 12, 28 weeks and 1 year post‐operatively

24 hour pad test, mean (SD) N

12 weeks: A 115 (300) 93, B 72 (144) 82

16 weeks: A 76 (259) 94, B 61 (194) 80

28 weeks: A 45 (142) 87, B 35 (101) 74

12 months: A 47 (215) 89, B 8 (10) 78

Dry at 8 weeks: A 20/101 (20%), B 20/88 (23%)

Dry at 12 weeks: A 30/93 (32%), B 23/82 (28%)

Dry at 16 weeks: A 41/94 (44%), B 32/80 (40%)

Dry at 28 weeks: A 41/87 (47%). B 37/74 (50%)

Dry at 12 months: A 53/89 60%, B 47/78 60% (< 8 g on pad test)

No significant differences between groups on continence or on symptom and quality of life measures or diary at any time point post‐operatively

Cost: A: CAD 400; B 240

Adverse events: none in either group

The majority of men reported a low impact of incontinence as per the IIQ‐7 and fewer LUTS at 12 months than at baseline on the IPSS. The majority were very satisfied with treatment and support from the continence nurse

Notes

Groups comparable at pre‐operation baseline on PSA, Gleason score, IPPS, IIQ, pad test and voiding diary

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated list of random numbers, random blocked allocation to groups

Allocation concealment (selection bias)

Low risk

Group allocation placed in sealed opaque envelopes; opened by participant after initial post‐operation instruction session with therapist

Blinding of participants (performance bias)

High risk

Blinding to intervention not possible

Blinding of personnel (performance bias)

Low risk

Therapist blinded to outcome of non‐intervention group; pads weighed by third party

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Data entry by clerk blinded to group

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Dropouts: control = 7; treatment = 12; no differential dropout

Selective reporting (reporting bias)

Unclear risk

Protocol not available. Therefore judged to be unclear risk

Financial support

Low risk

"Funded by the Alberta Heritage Foundation for Medical Research, the Northern Alberta Urology Foundation, and Pfizer Corporation (unrestricted)"

Approved by medical ethics committee

Low risk

"Healthcare ethics approval was obtained at all sites"

Informed consent

Low risk

"After the consent form was signed, baseline data were collected"

ITT analysis

Low risk

Patient flow chart give details of patient dropouts and withdrawals

Morihiro 2011

Methods

RCT abstract only

Participants

Time of recruitment: not reported

Population: men having laparoscopic radical prostatectomy

Included: patients who underwent laparoscopic radical prostatectomy performed by a single surgeon

Excluded: not reported

Age (mean, SD): not reported

Dropouts: not reported

Baseline characteristics: comparable at baseline

Interventions

Time of intervention: post‐operative treatment for all men

A (20): PFMT + sacral surface therapeutic ES (ssTES), ssTES 2 times a day for 15 minutes each, lasting 1 month after catheter removal (day 5)

B (14): PFMT only, carried out alone

Duration of treatment: 1 month 

Follow‐up: 1 month, 3 months, 6 months and 12 months post‐operatively

Outcomes

Primary outcome (number of men with UI)

Number of incontinent men (defined as requirement for a pad to keep clothing dry)

6 months: A 3/20; B 6/14

12 months: A 0/20; B 5/14

Other outcomes

Recovery rate of urinary continence (defined as no requirement for a pad to keep clothing dry)

6 months: A 17/20, B 8/14

12 months: A 20/20, B 9/14, P = 0.007

Quality of life

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

“randomly assigned”

Allocation concealment (selection bias)

Unclear risk

"randomly assigned"

Blinding of participants (performance bias)

High risk

Blinding to intervention not possible

Blinding of personnel (performance bias)

Unclear risk

No description. Therefore judged to be unclear risk

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No description. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Not enough information. Therefore judged to be unclear risk

Selective reporting (reporting bias)

Unclear risk

Protocol not available. Therefore judged to be unclear risk

Financial support

Low risk

None

Approved by medical ethics committee

Low risk

“ethics committee of Kitasato university of medicine”

Informed consent

Low risk

Yes

ITT analysis

Unclear risk

No description. Therefore judged to be unclear risk

Nowak 2007

Methods

Randomised: yes

Participants

Recruitment: pre‐operative

Included: men undergoing radical prostatectomy

Aged: 59 to 72 years

Interventions

Group A intervention: extra‐corporeal magnetic innervation (ExMI) based pelvic floor device

Group B control: PFMT alone

Treatment initiated one week after catheter removal

Duration of treatment: 10 weeks

Length of follow‐up: 12 months

Outcomes

On first day following catheter removal 16.8% of patients were continent

Subsequent follow‐up data unclear if N = 105 or 88 subjects. Group numbers not stated

UI at ‐

4 weeks: A 49%, B 56%

3 months: A 36%, B 50%

6 months; A 18%, B 32%

Twenty minute pad test at 12 months, significantly better in Group A at 12 months, P =0.004

QoL score and urinary symptom inventory also carried out, numbers not given

Notes

No useable data

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"randomized"

Allocation concealment (selection bias)

Unclear risk

No description. Therefore judged to be unclear risk

Blinding of participants (performance bias)

High risk

Blinding to intervention not possible

Blinding of personnel (performance bias)

Unclear risk

No description. Therefore judged to be unclear risk

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No description. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

One patient withdrew from Group A for non‐medical reasons

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Unclear risk

No description. Therefore judged to be unclear risk

Approved by medical ethics committee

Unclear risk

No description. Therefore judged to be unclear risk

Informed consent

Unclear risk

No description. Therefore judged to be unclear risk

ITT analysis

Unclear risk

Not specified. Therefore judged to be unclear risk

Opsomer 1994

Methods

Randomised: yes
Method of allocation: method not described
Blinding: none
Dropouts: 4
Intention to treat: not specified

Participants

Recruitment: post‐operative

Included: men incontinent post‐radical prostatectomy 6 weeks after six week after surgery

N = 43 (39 completed study)

Interventions

Post‐operative intervention

Group A (21) intervention: PFMT plus biofeedback plus ES directed by physiotherapist

Group B (22) control: PFME on their own without medical supervision

Length of follow‐up: 12 weeks

Outcomes

Main outcome: urine loss measured by pad test

No statistical difference between groups as to recovery of continence

Notes

Abstract only ‐ unable to contact author for further data

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No description. Therefore judged to be unclear risk

Allocation concealment (selection bias)

Unclear risk

"Randomised"

Blinding of participants (performance bias)

High risk

Blinding to intervention not possible

Blinding of personnel (performance bias)

Unclear risk

No description. Therefore judged to be unclear risk

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No description. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Four dropouts

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Unclear risk

No description. Therefore judged to be unclear risk

Approved by medical ethics committee

Unclear risk

No description. Therefore judged to be unclear risk

Informed consent

Unclear risk

No description. Therefore judged to be unclear risk

ITT analysis

Unclear risk

Not specified. Therefore judged to be unclear risk

Overgard 2008

Methods

Randomised: yes

Participants

Recruitment: Pre‐operative

Included: radical prostatectomy, all men

Age: Group A 48 to 68 years, Group B 49 to 72 years

Interventions

Intervention: post operative

Group A (38) intervention: instructions on PFMT and physiotherapy, 45 minutes weekly. Patients were instructed to perform 3 sets of contractions daily at home, in either a supine, sitting or standing position. Digital anal palpation to teach correct contractions, as well as oral and written instructions

DVD of instructions given to those living too far from hospital

Group B (42) control: instructions on PFMT alone

Duration of treatment: up to 1 year

Length of follow‐up: 3, 6 and 12 months

Outcomes

Self‐reported continence (not using pads)

3 months: A 16/35 (46%), B 17/40 (43%), P = 0.73

6 months: A 27/34 (79%), B 22/38 (58%), P = 0.061

12 months: A 33/36 (92%), B 28/39 (72%), P = 0.028

24 hour pad test: g/24hrs, mean (range)

3 months: A 17 (0‐282), B 7 (0‐46), P = 0.53

6 months: A 9 (0‐203), B 2 (0‐12), P = 0.73

12 months: A 2 (0‐55), B 1 (0‐14), P = 0.95

PFM strength (anal squeeze pressure, cm H2O), mean (SD)

3 months: A 50.7 (23.9), B 55.7 (25.6), P = 0.398

6 months: A 56.1 (21.7), B 65.8 (27.0), P = 0.117

12 months: A 64.0 (24.0), B 71.5 (26.2), P = 0.237.

Notes

No SDs

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Norwegian University performed the computerised randomisation procedure immediately after pre‐operative test

Allocation concealment (selection bias)

Low risk

Norwegian University performed the computerised randomisation procedure immediately after pre‐operative test. Urologist no prior knowledge of randomisation procedure

Blinding of participants (performance bias)

High risk

Blinding to intervention not possible

Blinding of personnel (performance bias)

High risk

Blinding to intervention not possible

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No information. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

High risk

Drop out rate was 6% Four lost to follow up in physiotherapy group, one lost in instructions only group

Selective reporting (reporting bias)

Low risk

Outcomes in methods reported

Financial support

Low risk

"The work was funded by The Norwegian Fund for Postgraduate Training in Physiotherapy and The Norwegian Cancer Society"

Approved by medical ethics committee

Low risk

"The study was approved by the Regional Committee for Medical and Health Research Ethics"

Informed consent

Low risk

"Eighty‐five men provided written informed consent"

ITT analysis

Low risk

Assumed from patient flow chart

Parekh 2003

Methods

Randomised: yes
Method of allocation: not described
Blinding: none
Dropouts: 1 from each of the control and treatment groups. Reasons not described
Intention to treat: yes, dropouts categorised as incontinent

Participants

Recruitment: pre‐operative

Included: all men scheduled for radical prostatectomy

N = 38 patients with localized carcinoma of the prostate

Interventions

Pre and post‐operative interventions

Group A (19) intervention: 2 treatment sessions pre‐operatively. Session 1 consisted of PFMT in a hook lying position
Session 2 was on an exercise ball. Teaching methods varied and included verbal cues, visualization with an anatomical model, palpation or biofeedback with rectal probe. Post‐operatively, PFMT was reviewed and participants were seen every 3 weeks for 3 months by a physiotherapist
Home exercise for 6 months or more for those requiring further physical therapy guidance

Group B (19) control: no formal education on PFMT pre‐operatively, telephone or face to face follow‐up at least monthly

Length of follow‐up: 12 months

Outcomes

Main outcome: urine loss measured by number of pads used daily

Continence definition: 0 pads or 1 precautionary pad used

Data collection: UI questionnaires at 6, 12, 16, 20, 28, and 52 weeks

Greater number of the intervention group gained continence earlier than the control group at 3 months (only point of statistical difference). Minimal long‐term effect as continence rates the same at 1 year

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"Patients were enrolled in prospective, randomized fashion into a treatment or a control group"

Allocation concealment (selection bias)

Unclear risk

"Randomly assigned"

Blinding of participants (performance bias)

High risk

Blinding to intervention not possible

Blinding of personnel (performance bias)

High risk

Blinding to intervention not possible

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

1 dropout from each arm. Categorised as incontinent

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Unclear risk

Not reported. Therefore judged to be unclear risk

Approved by medical ethics committee

Unclear risk

Not reported. Therefore judged to be unclear risk

Informed consent

Unclear risk

Not reported. Therefore judged to be unclear risk

ITT analysis

Unclear risk

Not reported. Therefore judged to be unclear risk

Park 2012

Methods

RCT

Participants

Time of recruitment: post‐operative

Population: 121 men who underwent radical prostatectomy (whole population, with or without UI)

Included: elderly male patients aged ≥ 65 years, clinically localized prostate cancer (cT1 to T2), Eastern Cooperative Oncology Group performance status of 0 or 1, and written informed consent

Excluded: adjuvant or neoadjuvant therapy, severe postoperative complications, a history of intrapelvic surgery, diseases that can affect voiding function, and limitations for exercise intervention, such as patients with serious cardiovascular events or spinal or articular disease

Age (mean, SD): A 69.1 (5.7); B 69.4 (7.2)

Dropouts: A: 7 (1 orthopaedic surgery for a pre‐existing ankle problem, 1 transurethral surgery for urethral stricture, 4 non‐compliance with follow‐up due to a long distance from the centre to the home or personal affairs, 1 new employment after surgery)

B: 8 (1 ophthalmologic surgery for a cataract, 2 adjuvant radiotherapy, 4 non‐compliance with follow‐up due to a long distance from the center to the home or personal affairs, 1 new employment after surgery)

Not differential dropout

Baseline characteristics: comparable at baseline

Interventions

Time of intervention: post‐operative treatment for all men

A (26): patients performed Kegel exercises twice weekly, together with other types of exercises which included resistance training and pelvic flexibility. The intervention started 3 weeks after surgery and lasted 12 weeks

B (23): ‘In the control group, only kegel exercises were performed’

Duration of treatment: 15 weeks

Follow‐up: 1 week before surgery, 3 weeks and 15 weeks after surgery

Outcomes

Primary outcome (number of men with UI)

Cumulative number of incontinent men [defined as > 1 g on 24 hour pad test)

15 weeks: A 7/26; B 13/23

Other outcomes

Cumulative number of continent men [defined as < 1 g on 24 hour pad test)

15 weeks: A 19/26; B 10/23, P = 0.035

Urine loss in grams using 24 hour pad test (mean (SD) N)

1 week before surgery: A 0 (NR) 26; B 0 (NR) 23

3 weeks post‐operatively: A 60 (NR) 26; B 83 (NR) 23

15 weeks: A 12 (NR) 26; B 46 (NR) 23

Quality of life

ICIQ score (mean (SD) N)

1 week before surgery: A 4 (NR) 26; B 3 (NR) 23

3 weeks post‐operatively: A 10 (NR) 26; B 10 (NR) 23

15 weeks: A 6 (NR) 26; B 10 (NR) 23

 

SF‐36 physical composite score (mean (SD) N)

1 week before surgery: A 57 (NR) 26; B 54 (NR) 23

3 weeks post‐operatively: A 45 (NR) 26; B 44 (NR) 23

15 weeks: A 57 (NR) 26; B 48 (NR) 23

 

SF‐36 mental composite score (mean (SD) N)

1 week before surgery: A 45 (NR) 26; B 44.6 (NR) 23

3 weeks post‐operatively: A 44 (NR) 26; B 43 (NR) 23

15 weeks: A 49 (NR) 26; B 46 (NR) 23

 

Beck Depression Inventory (mean (SD) N)

1 week before surgery: A 9 (NR) 26; B 7.4 (NR) 23

3 weeks post‐operatively: A 8 (NR) 26; B 9 (NR) 23

15 weeks: A 6 (NR) 26; B 9 (NR) 23 

NR = Not reported

Notes

Details of the combined exercise regime

Post‐operative weeks 1 to 4

1)    Education about post‐operative symptoms

2)    Performing Kegel exercises, recognizing the parapelvic muscles

3)    Pelvic floor flexibility fitness: performing pelvic exercises while sitting on a ball

Post‐operative weeks 5 to 8 (ball exercises)

1)    Performing pelvic exercises while sitting on a ball

2)    Performing lower extremity exercises while placing a ball on the wall

3)    Lifting a heel on the ball while standing face‐to‐face with the wall

4)    Lifting up and down on the ball while spreading and bending legs

5)    Performing flank exercises while having a ball in the hand

6)    Squeezing the ball with the adductor muscles while lying on a table

Post‐operative weeks 9‐12 (elastic band exercises)

1)    Lifting the object with an elastic band lateral, anterior, and posterior to the patient’s arms

2)    Lifting the legs and then spreading them while attaching an elastic band to the foot

Further information provided by author

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

“A random number generator was used to determine the randomization allocation in a 1:1 ratio”

Allocation concealment (selection bias)

Low risk

“Sealed envelope, sequentially numbered, and opened by the trial nurse”

Blinding of participants (performance bias)

High risk

Blinding of participants was not possible

Blinding of personnel (performance bias)

High risk

Blinding not possible

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

An independent assessor performed serial measurements

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

A: 7 (1 orthopaedic surgery for a pre‐existing ankle problem, 1 transurethral surgery for urethral stricture, 4 non‐compliance with follow‐up due to a long distance from the centre to the home or personal affairs, 1 new employment after surgery)

B: 8 (1 ophthalmologic surgery for a cataract, 2 adjuvant radiotherapy, 4 non‐compliance with follow up due to a long distance from the center to the home or personal affairs, 1 new employment after surgery)

No differential dropout

Selective reporting (reporting bias)

Low risk

Results of outcomes reported

Financial support

Low risk

Unconditional funding from the “Medical Research Institute, Pusan National University Hospital, Busan, Korea.”

Approved by medical ethics committee

Low risk

“Our institutional review board approved this prospective, randomized, controlled trial”

Informed consent

Low risk

Patients signed “written informed consent”

ITT analysis

High risk

No

Perissinotto 2008

Methods

Randomised: yes.

Method of allocation: consecutive patients

Participants

Pre‐operative randomisation

Included: all men undergoing radical prostatectomy

Pre‐operative intervention

Age: not given

Interventions

Group A (N not given) intervention: early pelvic floor rehabilitation program at home twice dally, Kegel exercises

Group B (N not given) control: no formal PFMT

Duration of treatment: for six months or until continence was achieved

Length of follow‐up: at 3 and 6 months

Outcomes

PFM strength: P = 0.002

Quality of life using ICIQ‐SF not significant

24 hour pad test not significant

Notes

No useable data

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Consecutive patients. No additional information provided. Therefore judged to be unclear risk

Allocation concealment (selection bias)

Unclear risk

Randomised controlled trial. No additional information provided. Therefore judged to be unclear risk

Blinding of participants (performance bias)

Unclear risk

No description. Therefore judged to be unclear risk

Blinding of personnel (performance bias)

Unclear risk

No description. Therefore judged to be unclear risk

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No description. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No description. Therefore judged to be unclear risk

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Low risk

"FAPESP" (Sao Paulo Research Foundation)

Approved by medical ethics committee

Low risk

"COMITE DE ESTICA E PESQUISA ‐ UNICAMP"

Informed consent

Low risk

Yes

ITT analysis

Unclear risk

Not specified

Porru 2001

Methods

Randomised: yes
Method of allocation: not described
Blinding: report stated that urologist performing digital evaluation of pelvic floor muscle contraction was blinded to the study group
Dropouts: intervention 2, control 1. Reason reported was non‐attendance at all clinic appointments
Intention to treat: none

Participants

Recruitment: pre‐operative

Included: all men undergoing TURP

N = 58 men (55 completed study) with benign prostatic hypertrophy randomised to 2 groups

Interventions

Pre and post‐operative intervention

Group A (30) intervention: initial visit before surgery, digital evaluation of pelvic muscle contraction strength. Verbal instruction, feedback and reinforcement on contraction was given to teach selective contraction of anal sphincter and relaxation of abdominal muscles. Verbal and written instruction given for home PFMT. Weekly digital anal reassessment and grading of pelvic muscle contraction by the therapist. Instructed to practice contractions 45 times per day (3 groups of 15 contractions)

Group B (28) control: not specified

Both A and B: voiding diaries initiated after catheter removal

Length of follow‐up: 4 weeks. Data collection at catheter removal and weekly for 4 weeks

Outcomes

Main outcome: urine loss (incontinence episodes) measured by 48 hour bladder diaries completed weekly

Secondary outcomes
Muscle contraction strength by digital evaluation Scale 0 to 4 (0 = none, 4 = strong)
Pressure flow: urine flowmetry pre‐operatively and 1 month post‐operatively
Symptoms: AUA (American Urological Association) symptom score preoperatively and 30 days after surgery
Quality of life: ICS male questionnaire

Significant increase in muscle strength in intervention group by week 4
Both groups showed improvement in symptom score and quality of life post‐operatively, no significant difference between groups
Significantly better satisfaction with life in intervention group A compared to control B at 4 weeks
Significant difference in voiding intervals between the groups at weeks 2 and 3, but not week 4
No difference in uroflowmetry
Significantly less incontinence in the intervention group A at weeks 1, 2 and 3. No difference at week 4
Concluded that PFMT quickens the return to normal voiding post‐TURP

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No description

Allocation concealment (selection bias)

Unclear risk

B ‐ 'randomised'

Blinding of participants (performance bias)

High risk

Blinding to intervention not possible

Blinding of personnel (performance bias)

Low risk

Urologist performing digital evaluation of pelvic floor muscle contraction was blinded to the study group

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

"One urologist, who was blinded to the study group of the patients, performed only the digital evaluation of the pelvic floor muscle contraction and established and reported the grading during all the visits"

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Dropouts due to non‐attendance at all clinic appointments (A 2, B 1)

Selective reporting (reporting bias)

Low risk

Results reported for outcomes stated in methods

Financial support

Unclear risk

No description. Therefore judged to be unclear risk

Approved by medical ethics committee

Unclear risk

No description. Therefore judged to be unclear risk

Informed consent

Low risk

"Informed consent was given by all patients"

ITT analysis

Unclear risk

Not specified

Ribeiro 2008

Methods

Randomised: yes

Participants

Post‐operative intervention

Included: radical prostatectomy, all men after catheter removal

Age: 51 to 76 years

Interventions

Group A (36) intervention: PFMT plus BF weekly for 3 months

Group B (37) control: PFMT oral instructions only

Duration of treatment: weekly until continent or to a maximum of 3 months

Length of follow‐up: 3 months after treatment finished

Outcomes

UI severity (24 hour pad test weights)

1 month (N, mean, SD): A 96 g (160) 36, B 355 (423) 37, P = 0.007

3 months: A 51 (119), 36, B 197 (269) 37

6 months: A 40 (77), 36, B 80 (176) 37

ICI‐SF score: 3 months:A 3.4 (3.7), 36, B 6.8 (5.6) 37, P = 0.022

6 months: A 2.7 (3.5), 36, B 4.3 (5.5) 37, P = 0.339

PFM Strength, A versus B: 1 month, P = 0.006; 3 months P < 0.001; 6 months P = 0.799

Quality of life (IIQ): 3 months: A 1.6 (2.7), 36, B 4.3 (6.2) 37

Notes

Groups comparable at baseline before operation on age, BMI, voiding symptoms and PFMT strength

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No description. Therefore judged to be unclear risk

Allocation concealment (selection bias)

Unclear risk

"Randomised controlled trial"

Blinding of participants (performance bias)

High risk

Blinding to intervention not possible

Blinding of personnel (performance bias)

High risk

Blinding not possible

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No information. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

19: A:10 (2 refused further follow‐up, 7 post‐operative complications, 1 radiotherapy); B: 9 (6 refused further follow‐up, 2 post‐operative complications, 1 radiotherapy). No differential dropout

Selective reporting (reporting bias)

Low risk

Outcomes in methods reported

Financial support

Low risk

Grant FAPESP 2003/07656‐7 (Sao Paulo Research Foundation)

Approved by medical ethics committee

Low risk

"institutional review board approval"

Informed consent

Low risk

"All patients signed an informed consent before randomization"

ITT analysis

Low risk

Assumed from patient flow chart

Robinson 2008

Methods

Randomisation: yes

Participants

Recruitment: pre‐operatively

Included: all men undergoing radical prostatectomy

Groups comparable at baseline

Age range 39 to 74 years

Pre‐operative UI 9%

Interventions

Group A (62) intervention: brief verbal instruction in PFMT before operation and offer of one biofeedback session at 2 months after surgery (uptake 33%) plus PFMT for four weeks with biofeedback

Group B (64) control: brief verbal instruction in PFMT before operation and offer of one biofeedback session at 2 months after surgery (uptake 46%)

Outcomes

No urinary outcomes provided

No between group differences in intensity and distress of lower urinary tract symptoms nor in impact on health‐related quality of life

Notes

No useable data

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated randomisation list

Allocation concealment (selection bias)

Low risk

The co‐project director who supervised the intervention was responsible for recruitment, but did not have access to the randomisation list

The co‐project director who supervised data collection was responsible for concealment of the randomisation list and allocation to the next available assignment on the list to participants sequentially as they enrolled

Blinding of participants (performance bias)

High risk

Participants were advised by the research assistant of their group assignment

Blinding of personnel (performance bias)

High risk

Questionnaires were filled in by research assistants either in person or by telephone interview

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No information. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No significant difference between groups in the number of participants who either withdrew prematurely or were dropped from the study. Questionnaires with > 20% data missing were excluded from analysis. In remainder mean substitution was inputted for missing data

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Low risk

"This study was supported by the American Cancer Society (TPRB‐98‐118‐01‐PBP) and a Rutgers College of Nursing Faculty Research Development Award"

Approved by medical ethics committee

Low risk

"Recruitment was initiated in January 1998 after approval of the parent study was obtained from the institutional review boards of both medical centres and the university"

Informed consent

Low risk

"Written informed consent was obtained by a research assistant"

ITT analysis

Low risk

"Data analysis was by intention‐to‐treat"

Robinson 2009

Methods

Randomisation: randomly assigned via sealed envelopes

Participants

Number of men 54 but no numbers in groups

Recuitment: post‐operatively

Included: radical prostatectomy, all with UI who were 50 + years, English speaking and were within a 50 mile radius of treatment centre

Age: mean 59.5 (6.3) years

Interventions

Group A intervention: routine brief verbal and written PFMT plus one PFMT session and 3 weekly nurse phone calls

Group B intervention: routine brief verbal and written PFMT plus four BF enhanced PFMT sessions and 4 weekly nurse phone calls

Group C control: routine brief verbal and written PFMT

Duration of treatment: 3 months

Length of follow‐up: 9 months

Outcomes

Urine stream interruption test (PFM strength)

Mishell Uncertainty in Illness Scale

Broome Pelvic Muscle self‐Efficacy Scale

UI frequency (3 day bladder diary)

24 hour pad test (volume of urine lost)

Male Urogenital Distress Inventory (UI distress)

Male Urinary Symptom Impact Questionnaire (QoL)

Notes

No useable data in abstract

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Via sealed envelopes

Allocation concealment (selection bias)

Unclear risk

No description. Therefore judged to be unclear risk

Blinding of participants (performance bias)

High risk

Blinding to intervention not possible

Blinding of personnel (performance bias)

Unclear risk

No description. Therefore judged to be unclear risk

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No description. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No description. Therefore judged to be unclear risk

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Low risk

"NIH/NINR"

Approved by medical ethics committee

Low risk

"Yes"

Informed consent

Low risk

"Following informed consent"

ITT analysis

Unclear risk

Not specified. Therefore judged to be unclear risk

Seleme 2008

Methods

Randomisation: yes, single blind

Method of allocation: using coloured cards

Participants

Post‐operative intervention

Included: men with UI eight weeks after radical prostatectomy

Exclusion: previous radiotherapy, anterior transurethral resection, diabetes mellitus and urethral obstruction after surgery

Age: median 63.7 years, range 46 to 83 years

Interventions

A (44) intervention: verbal instruction and information on PFMT plus information on life style changes. Additional 15 physiotherapy sessions consisting of intensive PFMT with BF and ES

B (32) control: verbal instruction and information on PFMT plus information on life style changes

Duration of treatment: no description

Length of follow‐up: 6 months

Outcomes

Incontinence Quality of life (I‐QoL, higher score better), mean (SD)

Directly after treatment: A 44.23 (14.61), B 37.53 (9.94)

At 6 months: A 80.32 (7.01), B 51.69 (16.17), P = 0.001

At 6 months for Group A (44) intervention only:

1 hour pad test: mean urine loss before treatment 54.2 g and after treatment 8.8 g (P > 0.001)

VAS severity of UI: before treatment 9.3, after treatment 1.3 (P > 0.001)

Notes

Unexplained disparity between numbers in randomised groups

No results for Group B control for pad test or VAS

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Coloured cards

Allocation concealment (selection bias)

Unclear risk

Method of selection unknown

Blinding of participants (performance bias)

High risk

Blinding not possible

Blinding of personnel (performance bias)

High risk

Blinding not possible

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

High risk

No information for Group B control for both the one hour pad test and the VAS severity of UI

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Low risk

"None"

Approved by medical ethics committee

Low risk

"Medical Ethical Committee of Nossa Senhora das Gracas Hospital in Curitiba, Brazil"

Informed consent

Low risk

"after signing informed consent"

ITT analysis

Unclear risk

Not reported. Therefore judged to be unclear risk

Tibaek 2007

Methods

Randomisation: yes, mathematical table, grouped in blocks of 10

Method of allocation: sealed envelopes by independent third party

Blinding: Slingle blind. Independent physiotherapist undertook initial assessment and 4 week outcome assessment

Dropouts: 9 before intervention (4, training too time consuming; 1, didn't have TURP; 4, operated elsewhere)

Setting: Hospital, Denmark

Participants

Pre‐operative intervention

Included: TURP, all men

Exclusion: prostate cancer, previous lower urinary tract surgery, neurological disease

Age: A 70 (58 to 77) years, B 68 (52 to 79) years

Interventions

Group A (26) intervention: 1 hour individual session with physiotherapist to teach correct contraction for PFMT, three 1 hour group lessons and home training programme

Group B (23) control: no pre‐operative physiotherapy. Information about anatomy and physiology and verbal instructions for 2 to 3 days after TURP in the ward

Duration of treatment: 4 weeks after surgery

Length of follow‐up: 2 and 4 weeks and 3 months after operation

Outcomes

Compliance: A 24/26 attended all 4 training sessions

Use of urinary pads per 24 hours, at 4 weeks: A 4/26, B 4/21. At 3 months: A 3/26, B 5/22

UI (pad test weight g/24hrs):

4 weeks (N, Median, range): A 26, 12 (0 to 374), B 23, 4 (0 to 56), P = 0.755

Danish Prostatic Symptom Scale: 3 months (N, median, range): A 26, 3 (0 to 24), B 23, 4.5 (0 to 51), P = 0.754

Also data on muscle function, muscle strength, static endurance and dynamic endurance

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Mathematical table, grouped in blocks of 10

Allocation concealment (selection bias)

Low risk

Sealed envelopes by independent third party

Blinding of participants (performance bias)

High risk

Not possible to blind to intervention

Blinding of personnel (performance bias)

Unclear risk

Independent physiotherapist undertook initial assessment and 4 week outcome assessment

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No description. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

High risk

Nine dropped out before intervention

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Low risk

None

Approved by medical ethics committee

Low risk

"This study was approved by the ethical committee in Copenhagen County and followed the Declaration of Helsinki"

Informed consent

Low risk

"Informed consent was obtained from the patients"

ITT analysis

Unclear risk

Not specified

Tienforti 2012

Methods

RCT

Participants

Time of recruitment: pre‐operative

Population: men undergoing radical prostatectomy (whole population, with or without UI)

Included: men who underwent open retropubic radical prostatectomy for clinically localized prostate cancer (cT1a to cT2b), able to regularly attend an ambulatory schedule

Excluded: prior diseases with a possible impact on urinary continence, preoperative radiotherapy and any medical condition that could limit participation in the training programme

Age (mean, range): A 67 (60 to 74); B 64 (52 to 74)

Dropouts: 1 from A (intolerance to procedure using rectal probe), 1 from B (surgical complication)

Not differential dropout

Baseline characteristics: comparable at baseline

Interventions

Time of intervention: pre‐operative

A (16): on the day before RP + the day after catheter removal, patients received guided PFMT + biofeedback + information about the anatomy of pelvic floor muscles and wrong execution was corrected, also given oral and written instructions on Kegel exercises to be performed at home, instructed to: perform three sets daily for 10 mins, each contraction lasting 5 seconds with 5 seconds of relaxation, contract their pelvic floor while lying, sitting and standing, frequency recorded in training diary, After RP visits at monthly intervals after catheter removal involving assisted biofeedback and motivation for 20 min

B (16): after catheter removal, men received standard care, oral and written instructions from urologist on PFMT, Instructed to: start PFMT (e.g. 2 to 3 weeks after surgery), control visits at 3 + 6 months after catheter removal  

All men were given oral and written instructions post‐operatively to perform PFMT at home, 3 sets daily of 10 min each

Duration of treatment: monthly visits as long as patient required pads, including safety pads

Follow up: at least 6 months after catheter removal

Outcomes

Primary outcome (number of men with UI)

Number of incontinent men (defined as ICIQ‐UI > 0)

1 month: A 10/16; B 16/16, P = 0.02

3 months: A 8/16; B 15/16, P = 0.01

6 months: A 6/16; B 15/16, P = 0.002

Other outcomes

Number of continent men (efined as ICIQ‐UI = 0)

1 month: A 6/16; B 0/16, P = 0.02

3 months: A 8/16; B 1/16, P = 0.01

6 months : A 10/16; B 1/16, P = 0.002

 

Mean number of incontinence episodes per week/24 hours (mean (SD) N)

1 month: A 1.43 (0.82) 16; B 14 (0.82) 16, P = N.S

3 months: A 0.57 (1.47) 16; B 2 (1.47) 16, P = 0.01

6 months: A 0.43 (1.33) 16; B 1.86 (1.33) 16, P = 0.005

 

Mean number of pads used per week/24 hours (mean (SD) N)

1 month: A 0.46 (0.67) 16; B 0.94 (0.67) 16 P = NS

3 months: A 0.23 (0.63) 16; B 0.91 (0.63) 16 P = 0.005

6 months: A 0.2 (0.57) 16; B 0.66 (0.57) 16 P = 0.03

 

Quality of life

Mean ICIQ‐OAB score (mean (SD) N)

1 month: A 11.5 (3.6) 16; B 14 (3.6) 16, P = NS

3 months: A 11 (0.92) 16; B 11.7 (0.92) 16, P = 0.04

6 months: A 9 (4.1) 16; B 13 (4.1) 16, P = 0.01

 

Mean UCLA‐PCI score (mean (SD) N)

1 month: A 330 (?) 16; B 260 (?) 16, P = NS

3 months: A 400 (500) 16; B 270 (338) 16, P = 0.006

6 months: A 430 (487) 26; B 275 (311) 16, P = 0.003

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

“Generated by computer and was stratified with a 1:1 allocation”

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants (performance bias)

High risk

“Participants were unblinded to treatment assignment”

Blinding of personnel (performance bias)

Low risk

“Surgeons and person scoring the evaluation questionnaires were blinded throughout the duration of the study”

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

“nurse scoring the evaluation questionnaires was blinded” to randomisation

Incomplete outcome data (attrition bias)
All outcomes

Low risk

1 from A (intolerance to procedure) 1 from B (surgical complication). Not differential dropout

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Unclear risk

Not reported

Approved by medical ethics committee

Low risk

“Work was carried out in accordance with the ethical standards of the appropriate institutional committee on human experimentation and with the last revision of the Helsinki Declaration

Informed consent

Low risk

“All eligible patients gave informed signed consent”

ITT analysis

Low risk

Assumed from patient flow diagram

Tobia 2008

Methods

Randomised: yes

Participants

Recruitment: pre‐operative

Included: all men, radical prostatectomy

Age: 45 to 75 years

Interventions

Group A (19) intervention: PFMT

Group B (19) control: no PFMT

length of follow‐up: 2, 4 and 8 weeks

Outcomes

Dry at 2 weeks: A 9/19, B 9/19

Dry at 4 weeks: A 9/19, B 9/19

Dry at 8 weeks: A 15/19, B 17/19, P = 0.374

No significant differences for age (P = 0.674), PSA (P = 0.208), Gleason score pre (P = 0.762) and post‐operation (P = 0.824)

Notes

Awaiting translation for more information.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No description. Therefore judged to be unclear risk

Allocation concealment (selection bias)

Unclear risk

No description. Therefore judged to be unclear risk

Blinding of participants (performance bias)

High risk

No description, Spanish language

Blinding of personnel (performance bias)

Unclear risk

No description. Therefore judged to be unclear risk

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No information. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No dropouts. Therefore judged to be unclear risk

Selective reporting (reporting bias)

Unclear risk

Spanish language

Financial support

Unclear risk

Unable to be determined

Approved by medical ethics committee

Unclear risk

Unable to be determined

Informed consent

Unclear risk

Unable to be determined

ITT analysis

Unclear risk

Unable to be determined

van Kampen 1998

Methods

Randomised: yes
Method of allocation: stratified randomisation with sealed envelopes. Stratified by grams of urine loss (< 50 , > 50, < 250, > 250 g)

Blinding: yes (outcome assessor not involved with the study)
Dropouts: 5

Intention to treat: yes

Participants

Recruitment: post‐operative

Included: men incontinent post‐radical prostatectomy 15 days after surgery after catheter removal

N = 102 eligible, 98 completed

Interventions

Post‐operative intervention

Group A (50) intervention: 1 session of PFMT in hospital before discharge and then saw the physiotherapist for 1 to 2 weeks for as long as UI persisted; 90 daily home exercises sitting, standing and lying; 7 men unable to contract PFM or with weak contraction received electrical stimulation by anal probe

Group B (52) control: No formal PFMT instruction but saw the therapist at 1 to 2 weeks and received placebo stimulation and information about aetiology of UI

Both A and B: received bladder training to increase bladder capacity

Length of follow‐up: 12 months

Outcomes

Main outcome: urine loss measured by 24 and 1 hour pad tests; 24 hour pad test done daily until continence achieved; 1 hour pad test when loss of < 2 g of urine to confirm continence

Secondary outcomes:
Subjective UI by visual analogue scale
Fluid Volume Chart
Quality of Life ‐ questionnaire designed for study

Continence definition:
Numbers cured defined as < 2 g urine loss on 24 and 1 hour pad tests

Data collection: subject assessment of continence preoperatively (during screening), and at 1, 6 and 12 months. Daily weighing of pads by participants (24 hour pad test)

Notes

Pragmatic study; policy of management left to clinical judgment as to which protocols to add to PFMT regime. 63 of the eligible subjects were unable to participate because of geographical reasons; demographics and post‐operative variables did not differ from the 102 subjects who were in the treatment groups

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Stratified by grams of urine loss (< 50 , > 50, < 250, > 250 g)

Allocation concealment (selection bias)

Low risk

A ‐ stratified randomisation with sealed envelopes

Blinding of participants (performance bias)

Unclear risk

The control group "received placebo electrotherapy that could not affect the pelvic‐floor muscle function."

Blinding of personnel (performance bias)

Unclear risk

"The patients in both groups were treated by the same therapist (MVK) until they became continent, within a period of 1 year"

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Outcome assessor not involved with the study

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Dropouts: 5

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Low risk

"supported by a grant from the Fund of Scientific Research, Flanders, Belgium"

Approved by medical ethics committee

Unclear risk

Not specified

Informed consent

Low risk

"All patients included in the study gave written informed consent"

ITT analysis

Low risk

"The groups were analysed on an intention‐to‐treat basis"

Wille 2003

Methods

Randomised: yes
Method of allocation: not described
Blinding: not mentioned
Dropouts: numbers participating at 3 and 12 months identified (for pad test, N = 116 at baseline, 79 at 3 months and 124 at 12 months), reason for dropouts not described

Participants

Recruitment: pre‐operative

Included: all men undergoing radical prostatectomy

N = 139 randomised (number in each group at various data collection points varied)

Interventions

Post‐operative intervention

Group A (47): PFMT alone

Group B (46): PFMT + ES; PFMT as above plus instructed by dedicated in ES via surface anal electrode and bio‐impulser (biphasic pulse with 1 second bursts, 5 second pulse width, 2 second pulse trains

Group C (46): PFMT + ES + biofeedback. As above plus biofeedback (anal probe) 15 minutes twice daily for 3 months

All groups A and B and C: PFMT by physiotherapist, 20‐30 minute sessions for 3 days, instructed to perform exercises twice daily for 3 months plus 3 week rehabilitation program after discharge. Regular interaction with health professional for 6 weeks after surgery, encouraged to performed treatment for 3 months post‐surgery

Length of follow‐up: 12 months

Outcomes

Main outcome: urine loss measure by continence questionnaire and 20 minute provocative pad test

Continence definition: reported use of 0 to 1 pads on questionnaire (subjective) or loss of less than 1 gram of urine on pad test

Data collection: baseline (after catheter removal), 3 months and 12 months post‐operatively

Willingness to undergo surgery again: A 73%, B 83%, C 73%

Quality of life EORCT QLQ‐C30: scores for physical; role; emotional; social; and global quality of life were not significantly different between the groups at 3 or 12 months (no SDs provided)

No significant differences in continence rates between the three groups at baseline, 3 months or 12 months (objective)

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"Prospective randomized trial" Method of sequence generation not specified

Allocation concealment (selection bias)

Unclear risk

"Prospective randomized trial" Method of sequence generation not specified

Blinding of participants (performance bias)

High risk

Blinding to intervention not possible

Blinding of personnel (performance bias)

Unclear risk

No description. Therefore judged to be unclear risk

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

High risk

"Results at baseline after catheter removal, at 3 and 12 months postoperatively were available for 139, 120 and 128 (questionnaires at three different time points) and 116, 79 and 124 (pad test at three different time points) patients, respectively". However, no information about individual groups

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Unclear risk

Not reported. Therefore judged to be unclear risk

Approved by medical ethics committee

Unclear risk

Not reported. Therefore judged to be unclear risk

Informed consent

Low risk

"Informed consent was obtained"

ITT analysis

Unclear risk

Not reported. Therefore judged to be unclear risk

Yamanishi 2006

Methods

Randomised: yes.

Blinding: double blind

Dropouts: 1 due to pain in the intervention group

Participants

Randomisation: postoperative

Included: radical prostatectomy, all with severe post‐operative UI of > 100 g after catheter removal

Age: mean 65.7 (7.0) years

Pre‐operative intervention

Interventions

All patients instructed pre‐operatively PFMT by nurses and continued after catheter removal

A (26) intervention: oral PFMT plus electrical stimulation for 15 minutes twice daily (50 Hz square waves, 300 µsec pulse duration, maximum output 70 mA (5 sec on, 5 sec off duty cycle)

B (30) control: oral PFMT plus sham stimulation (output 3 mA, 2 sec on, 13 sec off duty cycle)

Duration of treatment: until continent or 12 months

Length of follow‐up: 1, 3, 6 and 12 months after treatment

Dropouts: A 4/26, B 5/30 (including 2+4 with adverse effects)

Outcomes

Number of incontinent men

1 month: A 18/26, B 29/30

3 months: A 10/24, B 25/29

6 months: A 5/23, B 15/26

12 months: A 3/22, B 8/25

24 hour pad test weights (mean ml, SD, N)

1 month: A 210 (261) 26, B 423 (357) 30

3 months: A 81 (140) 24, B 232 (339) 29

6 months: A 20 (49) 23, B 132 (293) 26

12 months: A 18 (49) 22, B 98 (277) 25

Time until continent in months (mean, SD, N): A 2.71 (2.6) 22, B 6.82 (3.9) 25, P = 0.0006

ICIQ‐SF (mean score SD N; 0 to 21, higher = worse)

1 month: A 10.6 (6) 26, B 14.9 (4.9) 30

3 months: A 5.8 (5.7) 24, B 11.2 (5.7) 29

6 months: A 4.3 (6.2) 23, B 8.2 (5.3) 26

12 months: A 4.2 (6.2) 22, B 5.6 (6.5) 25

ICIQ‐QoL score (mean score SD N; 0 to 21; 0 to 10, higher = worse)

1 month: A 4.2 (3.5) 26, B 6 (3) 30

3 months: A 2.2 (2.3) 24, B 3.7 (2.9) 29

6 months: A 1.6 (3.1) 23, B 2.5 (2.2) 26

12 months: A 1.5 (3.1) 22, B 1.9 (2.5) 25

Adverse effects: A 2/26, B 4/30 (discomfort or anal pain)

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

By computer

Allocation concealment (selection bias)

Low risk

"None of the patients, doctors or medical staff knew which type of stimulation had been assigned until the key code was opened"

Blinding of participants (performance bias)

Low risk

Men were blinded to the intervention (sham, low energy stimulation in control group

Blinding of personnel (performance bias)

Low risk

Blinding of doctors, nurses and medical staff

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Blinding of assessors, medical staff

Incomplete outcome data (attrition bias)
All outcomes

Low risk

It is reported that "In the active ES group 2 patients discontinued after 2 and 3 months, respectively, due to urethral stricture at the bladder neck. In the sham group 1 patient discontinued treatment at 7 months because of an increase in prostate specific antigen and he then underwent radiation therapy". However, there is no evidence that dropout was related to trial interventions

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Low risk

"None"

Approved by medical ethics committee

Low risk

"Local ethical committee approval" was obtained

Informed consent

Low risk

"written informed consent from each subject was obtained"

ITT analysis

Unclear risk

Not reported. Therefore judged to be unclear risk

Yokoyama 2004

Methods

Randomised: yes

Method of allocation: not stated

Blinding: not mentioned

Dropouts: it appears that there are no dropouts but this is not specifically mentioned

Participants

Recruitment: post‐operative

Included: 36 men with urinary incontinence, >100g on 24hour pad test, one day after catheter removal

Mean age: Group A 67.2 years, Group B 68.2 years, Group C 66.2 years

Interventions

A (12) intervention: anal electrode for 15 minutes twice a day for 1 month

B (12) intervention: extra‐corporeal magnetic innervation, neocontrol system, treatment sessions 20 minutes, twice a week for 2 weeks

C (12) control: PFMT, digital anal teaching of correct contractions, then verbal and written instructions for home practice

Length of follow‐up: 2, 3, 4, 5 and 6 months

Outcomes

24 hour pad test weight (grams)

3 months: A 34 g, B 7.3 g, C 50 g.

6 months: for all groups less than 10 g

Quality of life measured by I‐QOL: improvement in all groups over time, no statistically significant difference between the groups

Remaining UI at 6 months: A 2/12, B 1/12, C 2/12

Notes

Adverse effects: None in any of the groups, no discomfort or irritation from anal probe

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No description. Therefore judged to be unclear risk

Allocation concealment (selection bias)

Unclear risk

Randomly assigned

Blinding of participants (performance bias)

Unclear risk

No description. Therefore judged to be unclear risk

Blinding of personnel (performance bias)

Unclear risk

No description. Therefore judged to be unclear risk

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No description. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Numbers not given

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Financial support

Unclear risk

Not reported

Approved by medical ethics committee

Low risk

"The local ethics committee approved the protocol procedure"

Informed consent

Low risk

"Each patient provided written informed consent"

ITT analysis

Unclear risk

Not reported. Therefore judged to be unclear risk

Zhang 2007

Methods

Randomised: yes

Method of allocation: not stated

Blinding: none

Dropouts: two did not complete the control follow‐up assessment because they believed the control group was not helpful

Participants

58 men approached, 33 consented, 3 dropouts

Recruitment: post‐operative

Included: all incontinent men 6 months after radical prostatectomy

Interventions

Group A (14) intervention: PFMT plus BF using rectal electrical sensor, initial 45 minute session with physical therapist then written instructions to carry out at home three times a day for 10 minutes. Plus support group, 6 meetings in 3 months with a health psychologist

Group B (15) control: PFMT plus BF using rectal electrical sensor, initial 45 minute session with physical therapist then written instructions to carry out at home three times a day for 10 minutes

Outcomes

Length of follow‐up: 3 months

Frequency of PFMT: 4 to 7 times per week A 12/14, B 6/13, P = 0.077

Use of pad or brief: A 7/14 (50%), B 11/13 (85%), P = 0.057

Not able to control urge to urinate and prevent leakage: A 4/14, B 8/13, P = 0.085

Nocturia per week (mean): A 13, B 15.08, P = 0.484

VAS for severity of UI: A 3.21, B 4.65, P = 0.057 (t = ‐1.902)

QoL measured by Illness Intrusiveness Questionnaires (IIRS): A 10.96, B 17.27, P = 0.037 Mann Whitney U = 48.5

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No description. Therefore judged to be unclear risk

Allocation concealment (selection bias)

Unclear risk

"Randomised"

Blinding of participants (performance bias)

High risk

Group therapy (unable to blind to intervention)

Blinding of personnel (performance bias)

Unclear risk

A research assistant, who was a doctoral candidate in medical anthropology, collected data under supervision

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not specified. Therefore judged to be unclear risk

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Two dropouts in the control group

Selective reporting (reporting bias)

Low risk

Outcomes reported

Financial support

Low risk

"This study was supported by an American Cancer Society pilot research grant and the Frances Payne Bolton School of Nursing at Case Western Reserve University"

Approved by medical ethics committee

Unclear risk

Not reported. Therefore judged to be unclear risk

Informed consent

Unclear risk

"33 patients consented to participate"

ITT analysis

Unclear risk

Not reported. Therefore judged to be unclear risk

ExMI = extra‐corporeal magnetic innervation; g = gram(s); PFMT = pelvic floor muscle training; TURP = transurethral resection of the prostate; UI = urinary incontinence

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Bennett 1997

Insufficient information to assess study for inclusion. Abstract only, no data included. Attempts to contact the author for data unsuccessful

Bocker 2002

Data from study that included male postprostatectomy and female post‐polio patients. Translation obtained as reported in German. Data from the two groups were not separated and therefore not in a usable form

Burkert 2011

Not measuring incontinence

Ceresoli 2002

Insufficient information to assess study for inclusion. Attempts to contact the author for data unsuccessful

Chang 1998

Data from study which involved post‐TURP patients. Two groups, treatment and control. Not randomly assigned to groups, first 25 consecutively assigned to control, next 25 to intervention

Cornel 2005

Descriptive study. No control group

Cornu 2011

RCT. PFMT + Duloxetine (drug) versus PFMT + placebo

Crevenna 2003

Descriptive pilot study. No control group

Dieperink 2013

Intervention after radiotherapy only

Eren 2013

RCT, 58 men after RP. Pharmacological intervention: Duloxetine + PFMT versus PFMT alone

Filocamo 2007

RCT, 112 men after RP. Pharmacological intervention: Duloxetine + PFMT versus PFMT alone

Griebling 1999

Insufficient information to assess study for inclusion. Data reported in paper presentation and in later published report did not contain sufficient detail of analysis to include in tables of comparison. Attempts to contact authors not successful in providing further data

Hotston 2006

Pharmacological intervention

Ip 2004

Education intervention (refrigerator magnet) not an intervention included in review

Kahihara 2006

A comparative study. Early versus delayed PFMT no randomisation

Lin 2012

Measuring erectile dysfunction only

McGlynn 2004

Descriptive study of change in education delivery approach. No control group

Mishel 2002

Data not separated for men who received radiotherapy and those who underwent prostate surgery

Nehra 2001

Insufficient information to assess study for inclusion. Abstract only. Attempts to contact authors for further data unsuccessful. Possibly ongoing trial but no further data available

Ottenbacher 2013

RCT but of written information about diet and general exercise

Pemberton 2006

Comparative study of different types of urinary sheath

Prota 2012

Measuring erectile dysfunction, no useable data

Pulker 2002

Descriptive study. No control group

Ribeiro 2013

Not prostatectomy

Ricci 2004 NEWa

Measuring "sensory urgency" only, not incontinence

Robinson 2012

Measuring the validity of a specific test, no useable data

Salinas Casado 1991

Descriptive study. No control group. Article in Spanish with English abstract

Salinas Casado 1996

Descriptive study. No control group. Article in Spanish with English abstract

Seki 2005

Descriptive study. No control group

Shen 2012 NEWa

Not looking at incontinence. Translation obtained as reported in Chinese

Traeger 2013

Data for men who received radiotherapy not separated from those who underwent prostate surgery

Yang 2010 NEWa

Not randomised. Translation obtained as reported in Chinese

Yao 2012

Not RCT. Physiotherapist‐guided PFMT versus control (retrospective analysis)

Zahariou 2009

Not randomised

Zermann 1999

Descriptive study. No control group

Zhang 2009

Data for men who received radiotherapy not separated from those who underwent surgery

Estim = Electrical stimulation

ExMI = Extra‐corporeal magnetic innervation

TURP = Transurethral resection of the prostate

Characteristics of studies awaiting assessment [ordered by study ID]

Crivellaro 2011

Methods

Not enough information

Participants

73 men after retropubic radical prostatectomy

Interventions

Ultrasound‐guided biofeedback versus biofeedback using verbal instructions and digital biofeedback

Outcomes

Notes

Authors to be contacted regarding whether assignment was randomised

Delmastro 2010

Methods

Open label RCT

Participants

Men scheduled for radical prostatectomy

Interventions

Preoperative intensive PFMT with or without proprioceptive training

Outcomes

Anal examination to assess pelvic floor muscle function; subjective and objective voiding and incontinence parameters; four tests of pelvic floor muscle function; PGI‐I; ICIQ‐male score

Notes

Further information needed from authors

Lilli 2006 NEW

Methods

Unclear if randomised, further information from authors required

Participants

Time of recruitment: pre‐operative

 

Population: Men having a radical prostatectomy (whole population, with or without UI)

 

Included: Men who were candidates for retropubic radical prostatectomy

 

Excluded: Acquired or congenital disability, cardiovascular diseases requiring the administration of drugs that interfere with voiding, e.g. diuretics and/or alphalytics, problems relating to vesico‐sphincteral innervations, episodes of unstable or transitory continence during their lifetime, any type of neuropathy, other cancers, and psychoaffective disturbances such as depression or insomnia

Age (mean, SD): A 68 (?); B 68 (?)

 

Dropouts: Not reported

Baseline characteristics:  Comparable at baseline

Interventions

Time of intervention: Pre‐operative

 

A (45): 20 mins of PFMT + biofeedback daily for 15 weeks before surgery, instructed to: carry out exercises during increased abdominal pressure (coughing, extending the abdomen, raising the head and keeping it raised), instructed how to carry out rapid, brief contractions without increasing abdominal activity and how to perform slow contractions

 

B (45): Instructed to start PFMT at home 15 weeks before surgery

 

After surgery and removal of catheter, all men were instructed to carry out four series of PF contractions at home on a daily basis for six months

 

Duration of treatment: 6 months

Follow up: 1 month, 3 months and 6 months after surgery

Outcomes

Primary outcome (number of men with UI):

Number of incontinent men (defined as use of pads):

Pre‐operative: A 0/45; B 0/45

1 month: A 42/45; B 42/45

3 months: A 30/45; B 33/45

6 months: A 13/45; B 15/45

Other outcomes:

Number of continent men (defined as completely dry without the use of pads):

Pre‐operative: A 45/45; B 45/45

1 month: A 3/45; B 3/45

3 months: A 15/45; B 12/45

6 months: A 32/45; B 30/45

Notes

Unclear if randomised

Simeit 2010 NEW

Methods

RCT

Participants

Men with urinary incontinence after radical prostatectomy

Interventions

A: PFMT

B: PFMT with additional 'BBS trainer'

Outcomes

Quality of life (EORTC questionnaire), impact of incontinence

Notes

Awaiting German translation

Zellner 2011 NEW

Methods

RCT

Participants

Men after radical prostatectomy

Interventions

A: PFMT + biofeedback + electrical stimulation

B: Whole body vibration

C: Guided PFMT

Outcomes

International Prostate Symptom Score (IPSS), the enclosed question about quality of life (IPSS‐QL), pad test, pelvic floor strength, maximum uroflow, micturition volume, serum testosterone and blood glucose

Notes

Awaiting German translation

Zhang 2013

Methods

RCT

Participants

127 Men with incontinence after “cancer treatment” Radical prostatectomy?

Interventions

A: Biofeedback + PFMT + 6 biweekly sessions of problem‐solving therapy delivered through a support group, B: Biofeedback + PFMT + 6 biweekly sessions of Problem‐solving therapy delivered through telephone contact, C (?): Standard care

Outcomes

Number of incontinent men [need for wearing a pad]

Notes

Further information required about participants + no useable data

Characteristics of ongoing studies [ordered by study ID]

Burnett 2012

Trial name or title

Health Interventions in Men Undergoing Radical Prostatectomy‐ A Randomized Controlled Clinical Trial

Methods

RCT

Participants

Men undergoing radical prostatectomy

Interventions

Intensive fitness intervention

Outcomes

Expanded Prostate Cancer Index (EPIC)‐26, RAND‐12 Questionnaire, body weight change, body mass index (BMI) change, blood pressure (BP) change, International Index of Erectile Function (IIEF), Quality of Erection Questionnaire (QEQ)

Starting date

December 2012

Contact information

Arthur L Burnett, Johns Hopkins Hospital, Baltimore, United States

Notes

Burnett 2013

Trial name or title

Study of Non‐Invasive Viberect Penile Vibratory Stimulation Regimen to Enhance Recovery of Erectile Function/Rigidity and Urinary Control/Continence After Nerve Sparing Radical Prostatectomy (RP) for Clinically Localized Prostate Cancer

Methods

RCT

Participants

Men with Urinary Incontinence

Interventions

Post‐operative use of Viberect device 3 days after catheter removal, daily usage for 7‐10 minutes versus no treatment

Outcomes

Recovery of erectile function following radical prostatectomy, IIEF, recovery of continence, EPIC urinary and and sexual domain, AUA, EHS EDITS and TSS questionnaires

Starting date

April 2013

Contact information

Arthur L. Burnett, M.D., Johns Hopkins University

Notes

Fode 2012 NEW

Trial name or title

Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence

Methods

RCT

Participants

Men with urinary incontinence more than 1 year after radical prostatectomy

Interventions

Medical vibrator used daily for 6 weeks

Outcomes

24 hour pad test, Micturition diary, Validated symptom score ICI‐Q, IPSS

Starting date

June 2012

Contact information

Copenhagen University Hospital at Herlev

Notes

Goode 2014

Trial name or title

Perioperative Post‐Prostatectomy Incontinence Home Telehealth Program (ProsTel)

Methods

RCT

Participants

Men undergoing radical prostatectomy

Interventions

Guided PFMT using a telehealth device (home messaging unit)

Outcomes

Time to continence using ICIQ‐SF, EPIC‐UI, HRQOL, IIQ‐SF, IPSS, patient satisfaction questionnaire, Estimated Percent improvement, Global perception of Improvement

Starting date

January 2012

Contact information

Department of Veterans Affairs

Notes

Mina 2013

Trial name or title

A Multicentre, Pilot Randomized Controlled Trial to Examine the Effects of Prehabilitation on Functional Outcomes After Radical Prostatectomy

Methods

RCT

Participants

Men undergoing radical prostatectomy

Interventions

Behavioral: Prehabilitation (PREHAB)

Outcomes

Adherence to Prehabilitation Program, Recruitment, Contamination, Study Retention, Physical Fitness, Quality of Life, Psychosocial Wellbeing, Physical Activity, Treatment Complications, Post‐operative length of stay

Starting date

November 2013

Contact information

Daniel Santa Mina, University Health Network, Toronto, Ontario, Canada

Notes

Ng 2011

Trial name or title

Trial study of the efficacy of intensive preoperative pelvic floor muscle training to decrease post‐prostatectomy urinary incontinence

Methods

RCT

Participants

Men with urinary incontinence after radical prostatectomy

Interventions

Preoperative guided PFMT 3 weeks before surgery versus PFMT on the day of admission for surgery

Outcomes

Pad test, IIQ‐7, SF 12

Starting date

February 2011

Contact information

Sau‐loi NG, Queen Mary Hospital, Hong Kong

Notes

Terrone 2007

Trial name or title

Prevention of Urinary Incontinence After Prostatectomy

Methods

RCT

Participants

Men undergoing radical prostatectomy

Interventions

BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercises

Outcomes

24‐hour PAD test: Complete continence

Starting date

February 2007

Contact information

Carlo Cisari, Azienda Ospedaliero Universitaria Maggiore della Carita

Notes

Zopf 2012

Trial name or title

Implementation and scientific evaluation of rehabilitative sports groups for prostate cancer patients: study protocol of the ProRehab Study

Methods

"Patient preference RCT"?

Participants

Men after radical prostatectomy

Interventions

exercise intervention ‐ rehabilitative sports group

Outcomes

"quality of life using EORTC‐QLQ‐C30/PR 25, incontinence using pad test and erectile dysfunction using IIEF"

Starting date

Contact information

German Sport University Cologne

Notes

Estim = Electrical stimulation

ExMI = Extra‐corporeal magnetic innervation

Data and analyses

Open in table viewer
Comparison 1. Treatment of UI after radical: PFMT ± biofeedback versus no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of incontinent men Show forest plot

9

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Analysis 1.1

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 1 Number of incontinent men.

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 1 Number of incontinent men.

1.1 less than 3 months

7

980

Risk Ratio (M‐H, Random, 95% CI)

0.95 [0.84, 1.08]

1.2 within 3‐6 months

7

895

Risk Ratio (M‐H, Random, 95% CI)

0.96 [0.83, 1.10]

1.3 within 6‐12 months

5

792

Risk Ratio (M‐H, Random, 95% CI)

0.91 [0.73, 1.14]

1.4 after 12 months

3

665

Risk Ratio (M‐H, Random, 95% CI)

0.85 [0.60, 1.22]

2 Number of incontinence episodes per day Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

Analysis 1.2

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 2 Number of incontinence episodes per day.

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 2 Number of incontinence episodes per day.

2.1 less than 3 months

2

400

Mean Difference (IV, Fixed, 95% CI)

‐1.09 [‐1.39, ‐0.78]

2.2 within 3‐6 months

1

227

Mean Difference (IV, Fixed, 95% CI)

‐0.20 [‐1.40, 1.00]

2.3 within 6‐12 months

1

217

Mean Difference (IV, Fixed, 95% CI)

‐0.20 [‐1.33, 0.93]

2.4 after first year

1

211

Mean Difference (IV, Fixed, 95% CI)

0.10 [‐0.82, 1.02]

3 Number of men using pads Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 1.3

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 3 Number of men using pads.

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 3 Number of men using pads.

3.1 less than 3 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 within 3‐6 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.3 within 6‐12 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.4 after 12 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Pad changes over 24 hours Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 1.4

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 4 Pad changes over 24 hours.

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 4 Pad changes over 24 hours.

4.1 less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.3 within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.4 after first year

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Urinary Incontinence Score (ICIQ‐SF) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 1.5

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 5 Urinary Incontinence Score (ICIQ‐SF).

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 5 Urinary Incontinence Score (ICIQ‐SF).

5.1 less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.3 within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.4 after first year

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 Quality of life related to urinary incontinence Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 1.6

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 6 Quality of life related to urinary incontinence.

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 6 Quality of life related to urinary incontinence.

6.1 less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.3 within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.4 after first year

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

7 Adverse events Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 1.7

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 7 Adverse events.

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 7 Adverse events.

8 24 hour pad test (grams of urine lost) Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

Analysis 1.8

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 8 24 hour pad test (grams of urine lost).

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 8 24 hour pad test (grams of urine lost).

8.1 less than 3 months

2

214

Mean Difference (IV, Fixed, 95% CI)

22.29 [‐33.12, 77.70]

8.2 within 3‐6 months

2

213

Mean Difference (IV, Fixed, 95% CI)

11.87 [‐40.77, 64.52]

8.3 within 6‐12 months

2

194

Mean Difference (IV, Fixed, 95% CI)

11.23 [‐22.35, 44.82]

8.4 after first year

1

167

Mean Difference (IV, Fixed, 95% CI)

39.0 [‐5.72, 83.72]

9 1 hour pad test (grams of urine lost) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 1.9

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 9 1 hour pad test (grams of urine lost).

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 9 1 hour pad test (grams of urine lost).

9.1 less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.3 within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.4 after first year

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

10 Number of men not carrying out pelvic floor muscle contractions at 12 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 1.10

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 10 Number of men not carrying out pelvic floor muscle contractions at 12 months.

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 10 Number of men not carrying out pelvic floor muscle contractions at 12 months.

Open in table viewer
Comparison 2. Treatment of UI after radical: electric or magnetic energy versus no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of incontinent men Show forest plot

4

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 2.1

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 1 Number of incontinent men.

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 1 Number of incontinent men.

1.1 less than 3 months

2

96

Risk Ratio (M‐H, Fixed, 95% CI)

0.77 [0.60, 0.98]

1.2 within 3‐6 months

1

53

Risk Ratio (M‐H, Fixed, 95% CI)

0.48 [0.29, 0.79]

1.3 within 6‐12 months

2

83

Risk Ratio (M‐H, Fixed, 95% CI)

0.37 [0.18, 0.73]

1.4 after 12 months

3

413

Risk Ratio (M‐H, Fixed, 95% CI)

0.26 [0.09, 0.74]

2 Adverse effects Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 2.2

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 2 Adverse effects.

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 2 Adverse effects.

3 24 hour pad test (grams of urine lost) Show forest plot

2

325

Mean Difference (IV, Fixed, 95% CI)

‐16.94 [‐58.21, 24.33]

Analysis 2.3

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 3 24 hour pad test (grams of urine lost).

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 3 24 hour pad test (grams of urine lost).

3.1 less than 3 months

2

96

Mean Difference (IV, Fixed, 95% CI)

‐27.82 [‐116.97, 61.33]

3.2 within 3‐6 months

2

93

Mean Difference (IV, Fixed, 95% CI)

5.12 [‐86.19, 96.43]

3.3 within 6‐12 months

2

89

Mean Difference (IV, Fixed, 95% CI)

‐1.95 [‐64.03, 60.13]

3.4 after first year

1

47

Mean Difference (IV, Fixed, 95% CI)

‐80.0 [‐190.50, 30.50]

4 Urinary Incontinence Score (ICIQ‐short form UI score) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 2.4

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 4 Urinary Incontinence Score (ICIQ‐short form UI score).

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 4 Urinary Incontinence Score (ICIQ‐short form UI score).

4.1 less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.3 within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.4 after first year

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Urinary Incontinence Quality of Life Score (ICIQ‐short form) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 2.5

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 5 Urinary Incontinence Quality of Life Score (ICIQ‐short form).

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 5 Urinary Incontinence Quality of Life Score (ICIQ‐short form).

5.1 less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.3 within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.4 after first year

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 Time until continent (months) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 2.6

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 6 Time until continent (months).

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 6 Time until continent (months).

Open in table viewer
Comparison 4. Treatment of UI after radical: combinations of treatments versus no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of incontinent men at < 3 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 4.1

Comparison 4 Treatment of UI after radical: combinations of treatments versus no treatment, Outcome 1 Number of incontinent men at < 3 months.

Comparison 4 Treatment of UI after radical: combinations of treatments versus no treatment, Outcome 1 Number of incontinent men at < 3 months.

1.1 PFMT + anal Estim + Biofeedback vs no treatment

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Number of incontinent men within 3‐6 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 4.2

Comparison 4 Treatment of UI after radical: combinations of treatments versus no treatment, Outcome 2 Number of incontinent men within 3‐6 months.

Comparison 4 Treatment of UI after radical: combinations of treatments versus no treatment, Outcome 2 Number of incontinent men within 3‐6 months.

2.1 PFMT + anal Estim + Biofeedback vs no treatment

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Number of incontinence episodes per day at > 3 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 4.3

Comparison 4 Treatment of UI after radical: combinations of treatments versus no treatment, Outcome 3 Number of incontinence episodes per day at > 3 months.

Comparison 4 Treatment of UI after radical: combinations of treatments versus no treatment, Outcome 3 Number of incontinence episodes per day at > 3 months.

3.1 PFMT + anal Estim + BFB

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Adverse effects Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 4.4

Comparison 4 Treatment of UI after radical: combinations of treatments versus no treatment, Outcome 4 Adverse effects.

Comparison 4 Treatment of UI after radical: combinations of treatments versus no treatment, Outcome 4 Adverse effects.

4.1 PFMT + anal Estim + BFB

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 5. Treatment of UI after radical: one active treatment versus another active treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of incontinent men at < 3 months Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 5.1

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 1 Number of incontinent men at < 3 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 1 Number of incontinent men at < 3 months.

1.1 PFMT + Anal EStim vs PFMT alone

2

177

Risk Ratio (M‐H, Fixed, 95% CI)

0.96 [0.83, 1.12]

2 Number of incontinent men within 3 to 6 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 5.2

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 2 Number of incontinent men within 3 to 6 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 2 Number of incontinent men within 3 to 6 months.

2.1 PFMT + BF + support group vs PFMT + BF

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Number of incontinent men within 6 to 12 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 5.3

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 3 Number of incontinent men within 6 to 12 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 3 Number of incontinent men within 6 to 12 months.

3.1 FES vs ExMI

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Number of incontinence episodes at < 3 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 5.4

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 4 Number of incontinence episodes at < 3 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 4 Number of incontinence episodes at < 3 months.

4.1 PFMT + anal EStim vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Quality of Life Score (severity of UI) within 3 to 6 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 5.5

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 5 Quality of Life Score (severity of UI) within 3 to 6 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 5 Quality of Life Score (severity of UI) within 3 to 6 months.

5.1 PFMT + BF + support group vs PFMT + BF

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 Quality of Life Score (I‐QoL) within 6‐12 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 5.6

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 6 Quality of Life Score (I‐QoL) within 6‐12 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 6 Quality of Life Score (I‐QoL) within 6‐12 months.

6.1 PFMT + BF + EStim vs PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

7 Quality of Life Score (ICI‐Q‐SF) within 6‐12 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 5.7

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 7 Quality of Life Score (ICI‐Q‐SF) within 6‐12 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 7 Quality of Life Score (ICI‐Q‐SF) within 6‐12 months.

7.1 PFMT + ExMI vs PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

8 Adverse events Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 5.8

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 8 Adverse events.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 8 Adverse events.

8.1 PFMT + Anal EStim vs PFMT alone

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9 1 hour pad test (grams of urine lost): at < 3 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 5.9

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 9 1 hour pad test (grams of urine lost): at < 3 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 9 1 hour pad test (grams of urine lost): at < 3 months.

9.1 PFMT + anal EStim vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.2 PFMT + perineal EStim vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.3 PFMT + perineal EStim vs PFMT + anal EStim

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

10 24 hour pad test (grams of urine lost): at < 3 months Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 5.10

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 10 24 hour pad test (grams of urine lost): at < 3 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 10 24 hour pad test (grams of urine lost): at < 3 months.

10.1 PFMT + anal EStim vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.2 PFMT + visual BF vs PFMT + oral BF

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

11 24 hour pad test (grams of urine lost): within 3 to 6 months Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 5.11

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 11 24 hour pad test (grams of urine lost): within 3 to 6 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 11 24 hour pad test (grams of urine lost): within 3 to 6 months.

11.1 PFMT + anal EStim vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

11.2 PFMT + visual BF vs PFMT + oral BF

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

12 24 hour pad test (grams of urine lost): within 3 to 6 months Show forest plot

3

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 5.12

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 12 24 hour pad test (grams of urine lost): within 3 to 6 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 12 24 hour pad test (grams of urine lost): within 3 to 6 months.

12.1 PFMT + anal EStim vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

12.2 PFMT + visual BF vs PFMT + oral BF

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

12.3 ExMI vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

13 Pad changes over 24 hours within 3 to 6 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 5.13

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 13 Pad changes over 24 hours within 3 to 6 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 13 Pad changes over 24 hours within 3 to 6 months.

13.1 ExMI vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

14 Number of men not carrying out sufficient PFMT within 3 to 6 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 5.14

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 14 Number of men not carrying out sufficient PFMT within 3 to 6 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 14 Number of men not carrying out sufficient PFMT within 3 to 6 months.

14.1 PFMT + BF + support group vs PFMT + BF

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 6. Prevention of UI after radical: PFMT ± biofeedback versus no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of incontinent men Show forest plot

8

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Analysis 6.1

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 1 Number of incontinent men.

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 1 Number of incontinent men.

1.1 less than 3 months

7

663

Risk Ratio (M‐H, Random, 95% CI)

0.93 [0.83, 1.06]

1.2 within 3‐6 months

7

697

Risk Ratio (M‐H, Random, 95% CI)

0.85 [0.75, 0.97]

1.3 within 6‐12 months

6

640

Risk Ratio (M‐H, Random, 95% CI)

0.51 [0.35, 0.75]

1.4 after 12 months

2

373

Risk Ratio (M‐H, Random, 95% CI)

0.32 [0.20, 0.51]

2 Pad changes over 24 hours Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 6.2

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 2 Pad changes over 24 hours.

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 2 Pad changes over 24 hours.

2.1 less than 3 months

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 within 3‐6 months

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 within 6 ‐ 12 months

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 1 hour pad test (grams of urine lost) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 6.3

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 3 1 hour pad test (grams of urine lost).

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 3 1 hour pad test (grams of urine lost).

3.1 Less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 Within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.3 Within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 24 hour pad test (gm/24hrs) Show forest plot

4

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 6.4

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 4 24 hour pad test (gm/24hrs).

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 4 24 hour pad test (gm/24hrs).

4.1 less than 3 months

3

424

Mean Difference (IV, Random, 95% CI)

‐78.19 [‐211.46, 55.07]

4.2 within 3‐6 months

2

373

Mean Difference (IV, Random, 95% CI)

‐73.28 [‐196.42, 49.86]

4.3 within 6‐12 months

2

373

Mean Difference (IV, Random, 95% CI)

‐14.50 [‐18.36, ‐10.64]

4.4 after first year

2

378

Mean Difference (IV, Random, 95% CI)

‐1.0 [‐1.81, ‐0.19]

5 Number of incontinence episodes per day Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 6.5

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 5 Number of incontinence episodes per day.

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 5 Number of incontinence episodes per day.

5.1 less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.3 within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.4 after first year

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 Urinary Incontinence Score (ICI‐short form) Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 6.6

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 6 Urinary Incontinence Score (ICI‐short form).

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 6 Urinary Incontinence Score (ICI‐short form).

6.1 less than 3 months

1

32

Mean Difference (IV, Random, 95% CI)

6.5 [3.45, 9.55]

6.2 within 3‐6 months

2

105

Mean Difference (IV, Random, 95% CI)

‐1.21 [‐5.99, 3.56]

6.3 within 6‐12 months

2

105

Mean Difference (IV, Random, 95% CI)

‐0.69 [‐3.19, 1.81]

7 Quality of Life Score (IIQ) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 6.7

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 7 Quality of Life Score (IIQ).

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 7 Quality of Life Score (IIQ).

7.1 less than 3 months

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.3 within 6‐12 months

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.4 after first year

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

8 Pelvic floor muscle strength (anal squeeze pressure, cm H2O) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 6.8

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 8 Pelvic floor muscle strength (anal squeeze pressure, cm H2O).

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 8 Pelvic floor muscle strength (anal squeeze pressure, cm H2O).

8.1 less than 3 months

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.3 within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.4 after first year

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

9 Number of men not carrying out sufficient PFMT Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 6.9

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 9 Number of men not carrying out sufficient PFMT.

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 9 Number of men not carrying out sufficient PFMT.

9.1 less than 3 months

0

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.2 within 3‐6 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.3 within 6‐12 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.4 after 12 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10 Number of men having surgery for incontinence Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 6.10

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 10 Number of men having surgery for incontinence.

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 10 Number of men having surgery for incontinence.

Open in table viewer
Comparison 7. Prevention of UI after radical: electric or magnetic energy versus no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 1 hour pad test (grams of urine lost) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 7.1

Comparison 7 Prevention of UI after radical: electric or magnetic energy versus no treatment, Outcome 1 1 hour pad test (grams of urine lost).

Comparison 7 Prevention of UI after radical: electric or magnetic energy versus no treatment, Outcome 1 1 hour pad test (grams of urine lost).

1.1 Less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 Within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 Within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 ICIQ‐SF score Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 7.2

Comparison 7 Prevention of UI after radical: electric or magnetic energy versus no treatment, Outcome 2 ICIQ‐SF score.

Comparison 7 Prevention of UI after radical: electric or magnetic energy versus no treatment, Outcome 2 ICIQ‐SF score.

2.1 Less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 Within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.3 Within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 9. Prevention of UI after radical: combinations of treatments versus no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of incontinent men within 3 to 6 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 9.1

Comparison 9 Prevention of UI after radical: combinations of treatments versus no treatment, Outcome 1 Number of incontinent men within 3 to 6 months.

Comparison 9 Prevention of UI after radical: combinations of treatments versus no treatment, Outcome 1 Number of incontinent men within 3 to 6 months.

1.1 PFMT + anal Estim + Biofeedback versus no treatment/sham treatment

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Number of incontinent men within 6 to 12 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 9.2

Comparison 9 Prevention of UI after radical: combinations of treatments versus no treatment, Outcome 2 Number of incontinent men within 6 to 12 months.

Comparison 9 Prevention of UI after radical: combinations of treatments versus no treatment, Outcome 2 Number of incontinent men within 6 to 12 months.

2.1 PFMT + anal Estim + biofeedback versus no treatment

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 24 hour pad test (grams of urine lost) within 3 to 6 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 9.3

Comparison 9 Prevention of UI after radical: combinations of treatments versus no treatment, Outcome 3 24 hour pad test (grams of urine lost) within 3 to 6 months.

Comparison 9 Prevention of UI after radical: combinations of treatments versus no treatment, Outcome 3 24 hour pad test (grams of urine lost) within 3 to 6 months.

3.1 PFMT + anal Estim + Biofeedback versus no treatment/sham treatment

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 24 hour pad test (grams of urine lost) 6 to 12 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 9.4

Comparison 9 Prevention of UI after radical: combinations of treatments versus no treatment, Outcome 4 24 hour pad test (grams of urine lost) 6 to 12 months.

Comparison 9 Prevention of UI after radical: combinations of treatments versus no treatment, Outcome 4 24 hour pad test (grams of urine lost) 6 to 12 months.

4.1 PFMT + anal Estim + Biofeedback versus no treatment/sham treatment

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Time until continent (months) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 9.5

Comparison 9 Prevention of UI after radical: combinations of treatments versus no treatment, Outcome 5 Time until continent (months).

Comparison 9 Prevention of UI after radical: combinations of treatments versus no treatment, Outcome 5 Time until continent (months).

5.1 PFMT + anal Estim + Biofeedback versus no treatment/sham treatment

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 10. Prevention of UI after radical: one active treatment versus another active treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of incontinent men at < 3months Show forest plot

3

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 10.1

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 1 Number of incontinent men at < 3months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 1 Number of incontinent men at < 3months.

1.1 PFMT pre and post op vs PFMT post op

2

289

Risk Ratio (M‐H, Fixed, 95% CI)

0.86 [0.69, 1.06]

1.2 PFMT + Biofeedback + transcutaneous Estim versus Estim only

1

54

Risk Ratio (M‐H, Fixed, 95% CI)

0.88 [0.61, 1.26]

1.3 PFMT + Biofeedback + transcutaneous Estim versus post‐op PFMT

1

54

Risk Ratio (M‐H, Fixed, 95% CI)

0.80 [0.57, 1.11]

1.4 Post‐op transcutaneous Estim versus post‐op PFMT

1

52

Risk Ratio (M‐H, Fixed, 95% CI)

0.90 [0.67, 1.22]

2 Number of incontinent men within 3 to 6 months Show forest plot

4

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 10.2

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 2 Number of incontinent men within 3 to 6 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 2 Number of incontinent men within 3 to 6 months.

2.1 PFMT pre and post op vs PFMT post op

2

290

Risk Ratio (M‐H, Fixed, 95% CI)

0.75 [0.54, 1.04]

2.2 post‐op PFMT + biofeedback + transcutaneous Estim vs post‐op Estim

1

54

Risk Ratio (M‐H, Fixed, 95% CI)

1.55 [0.96, 2.49]

2.3 PFMT + general exercise versus PFMT alone

1

49

Risk Ratio (M‐H, Fixed, 95% CI)

0.48 [0.23, 0.99]

2.4 Post‐op PFMT + transcutaneous Estim + Biofeedback versus post‐op PFMT

1

54

Risk Ratio (M‐H, Fixed, 95% CI)

1.09 [0.76, 1.57]

2.5 Post‐op transcutaneous electrical stimulation versus post‐op PFMT

1

52

Risk Ratio (M‐H, Fixed, 95% CI)

0.71 [0.43, 1.16]

3 Number of incontinent men within 6 to 12 months Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 10.3

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 3 Number of incontinent men within 6 to 12 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 3 Number of incontinent men within 6 to 12 months.

3.1 PFMT pre and post op vs PFMT post op

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 post‐op PFMT + Biofeedback + transcutaneous Estim vs post‐op Estim

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.3 Post‐op PFMT + transcutaneous Estim + Biofeedback versus post‐op PFMT

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.4 Post‐op transcutaneous Estim versus post‐op PFMT

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Number of incontinent men after 12 months Show forest plot

4

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 10.4

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 4 Number of incontinent men after 12 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 4 Number of incontinent men after 12 months.

4.1 PFMT pre and post op vs PFMT post op

3

367

Risk Ratio (M‐H, Fixed, 95% CI)

1.32 [0.78, 2.25]

4.2 PFMT + Penile vibration pre and post op versus PFMT pre and post op

1

58

Risk Ratio (M‐H, Fixed, 95% CI)

1.4 [0.25, 7.77]

5 No. with severe incontinence (e.g. pad test weight >150g) at < 3 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 10.5

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 5 No. with severe incontinence (e.g. pad test weight >150g) at < 3 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 5 No. with severe incontinence (e.g. pad test weight >150g) at < 3 months.

5.1 PFMT pre and post op vs PFMT post op

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 No. with severe incontinence (e.g. pad test weight >150g) at 3 to 6 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 10.6

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 6 No. with severe incontinence (e.g. pad test weight >150g) at 3 to 6 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 6 No. with severe incontinence (e.g. pad test weight >150g) at 3 to 6 months.

6.1 PFMT pre and post op vs PFMT post op

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7 20 minute pad test (grams of urine lost): within 3 to 6 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 10.7

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 7 20 minute pad test (grams of urine lost): within 3 to 6 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 7 20 minute pad test (grams of urine lost): within 3 to 6 months.

7.1 PFMT + anal EStim vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.2 PFMT + anal EStim + BF vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.3 PFMT + anal EStim vs PFMT + anal EStim + BF

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

8 20 minute pad test (grams of urine lost): within 6 to 12 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 10.8

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 8 20 minute pad test (grams of urine lost): within 6 to 12 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 8 20 minute pad test (grams of urine lost): within 6 to 12 months.

8.1 PFMT + anal EStim vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.2 PFMT + anal EStim + BF vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.3 PFMT + anal EStim vs PFMT + anal EStim + BF

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

9 1 hour pad test (grams of urine lost) at less than 3 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 10.9

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 9 1 hour pad test (grams of urine lost) at less than 3 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 9 1 hour pad test (grams of urine lost) at less than 3 months.

9.1 Pre‐op PFMT + Estim versus pre‐op PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

10 1 hour pad test (grams of urine lost) within 3‐6 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 10.10

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 10 1 hour pad test (grams of urine lost) within 3‐6 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 10 1 hour pad test (grams of urine lost) within 3‐6 months.

10.1 Pre‐op PFMT + electrical stimulation versus pre‐op PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

11 1 hour pad test within 6‐12 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 10.11

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 11 1 hour pad test within 6‐12 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 11 1 hour pad test within 6‐12 months.

11.1 Pre‐op PFMT + electrical stimulation versus pre‐op PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

12 24 hour pad test (grams of urine lost) at less than 3 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 10.12

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 12 24 hour pad test (grams of urine lost) at less than 3 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 12 24 hour pad test (grams of urine lost) at less than 3 months.

12.1 PFMT + Biofeedback + transcutaneous Estim versus Estim only

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

12.2 Post‐operative PFMT + transcutaneous Estim + Biofeedback versus post‐operative PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

12.3 Post‐operative transcutaneous electrical stimulation versus post‐operative PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

13 24 hour pad test (grams of urine lost) within 3‐6 months Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 10.13

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 13 24 hour pad test (grams of urine lost) within 3‐6 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 13 24 hour pad test (grams of urine lost) within 3‐6 months.

13.1 PFMT + Biofeedback + transcutaneous Estim versus Estim only

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

13.2 Postoperative PFMT + biofeedback + transcutaneous Estim versus postoperative PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

13.3 Post‐operative transcutaneous Estim only versus post‐operative PFMT only

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

13.4 PFMT + general exercise versus PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

14 24 hour pad test (grams of urine lost) within 6‐12 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 10.14

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 14 24 hour pad test (grams of urine lost) within 6‐12 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 14 24 hour pad test (grams of urine lost) within 6‐12 months.

14.1 PFMT + transcutaneous Estim + biofeedback versus Estim only

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

14.2 Post‐op PFMT + transcutaneous Estim + Biofeedback versus post‐op PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

14.3 Post‐op transcutaneous Estim versus post‐op PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

15 Quality of Life Score (ICS male short form) at < 3 months Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 10.15

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 15 Quality of Life Score (ICS male short form) at < 3 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 15 Quality of Life Score (ICS male short form) at < 3 months.

15.1 PFMT pre and post op vs PFMT post op

2

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

16 Urinary Incontinence Quality of Life Score (ICIQ ‐ short form) within 3‐6 months Show forest plot

3

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 10.16

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 16 Urinary Incontinence Quality of Life Score (ICIQ ‐ short form) within 3‐6 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 16 Urinary Incontinence Quality of Life Score (ICIQ ‐ short form) within 3‐6 months.

16.1 Pre‐op PFMT + electrical stimulation versus pre‐op PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

16.2 PFMT + general exercise versus PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

16.3 PFMT pre and post op vs PFMT post op

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

17 Urinary Incontinence Quality of Life Score (ICIQ‐short form) within 6‐12 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 10.17

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 17 Urinary Incontinence Quality of Life Score (ICIQ‐short form) within 6‐12 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 17 Urinary Incontinence Quality of Life Score (ICIQ‐short form) within 6‐12 months.

17.1 Pre‐op PFMT + electrical stimulation versus pre‐op PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

18 King's health Questionnaire after 12 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 10.18

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 18 King's health Questionnaire after 12 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 18 King's health Questionnaire after 12 months.

18.1 General Health

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

18.2 Role limitations

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

18.3 Physical limitations

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

18.4 Social limitations

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

18.5 Personal

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

18.6 Emotional

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

18.7 Sleep/energy disturbance

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

18.8 Symptom severity

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

19 Health status measure SF‐36 within 3‐6 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 10.19

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 19 Health status measure SF‐36 within 3‐6 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 19 Health status measure SF‐36 within 3‐6 months.

19.1 Physical composite score

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

19.2 Mental Composite score

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

20 Adverse events Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 10.20

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 20 Adverse events.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 20 Adverse events.

20.1 PFMT pre and post op vs PFMT post op

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

20.2 PFMT + Penile vibration pre and post op versus PFMT pre and post op

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 11. Treatment of UI after TURP: PFMT ± biofeedback versus no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of incontinent men Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 11.1

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 1 Number of incontinent men.

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 1 Number of incontinent men.

1.1 less than 3 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 within 3‐6 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 within 6‐12 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.4 after 12 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Number of incontinence episodes per day Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 11.2

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 2 Number of incontinence episodes per day.

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 2 Number of incontinence episodes per day.

2.1 less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.3 within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.4 after first year

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Number of men using pads Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 11.3

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 3 Number of men using pads.

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 3 Number of men using pads.

3.1 less than 3 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 within 3‐6 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.3 within 6‐12 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.4 after 12 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Urinary Incontinence Score (ICI‐short form) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 11.4

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 4 Urinary Incontinence Score (ICI‐short form).

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 4 Urinary Incontinence Score (ICI‐short form).

4.1 less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.3 within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.4 after first year

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Quality of life related to urinary incontinence Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 11.5

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 5 Quality of life related to urinary incontinence.

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 5 Quality of life related to urinary incontinence.

5.1 less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.3 within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.4 after first year

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 Number of men not carrying out pelvic floor muscle contractions at 12 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 11.6

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 6 Number of men not carrying out pelvic floor muscle contractions at 12 months.

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 6 Number of men not carrying out pelvic floor muscle contractions at 12 months.

Open in table viewer
Comparison 16. Prevention of UI after TURP:  pre or post‐operative PFMT ± biofeedback versus no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of incontinent men Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 16.1

Comparison 16 Prevention of UI after TURP:  pre or post‐operative PFMT ± biofeedback versus no treatment, Outcome 1 Number of incontinent men.

Comparison 16 Prevention of UI after TURP:  pre or post‐operative PFMT ± biofeedback versus no treatment, Outcome 1 Number of incontinent men.

1.1 less than 3 months

2

105

Risk Ratio (M‐H, Fixed, 95% CI)

0.60 [0.21, 1.77]

1.2 within 3‐6 months

1

48

Risk Ratio (M‐H, Fixed, 95% CI)

0.51 [0.14, 1.89]

2 Health status measure SF‐36 within 3‐6 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Analysis 16.2

Comparison 16 Prevention of UI after TURP:  pre or post‐operative PFMT ± biofeedback versus no treatment, Outcome 2 Health status measure SF‐36 within 3‐6 months.

Comparison 16 Prevention of UI after TURP:  pre or post‐operative PFMT ± biofeedback versus no treatment, Outcome 2 Health status measure SF‐36 within 3‐6 months.

2.1 Physical component

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 Physical functioning

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.3 Body pain

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.4 General Health

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.5 Physical role limitation

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.6 Mental health component

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.7 Mental role limitation

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.8 Vitality

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.9 Mental health

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.10 Social functioning

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 21. Containment of urinary incontinence from any cause: external penile compression devices (penile clamps) versus no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of men satisfied with device Show forest plot

Other data

No numeric data

Analysis 21.1

Study

Control (no device)

U‐Tex

C3

Cunningham

Moore 2004

0/12

0/12

2/12

10/12



Comparison 21 Containment of urinary incontinence from any cause: external penile compression devices (penile clamps) versus no treatment, Outcome 1 Number of men satisfied with device.

2 Mean urine loss (grams of urine on pad test) Show forest plot

Other data

No numeric data

Analysis 21.2

Study

Control (no device)

U‐Tex

C3

Cunningham

Moore 2004

122.8 gm (SD 130.8)

53.3 gm (SD 65.7)
P<0.05 vs Control (no device)

32.3 gm (SD 24.3)
P<0.05 vs Control (no device)

17.1 gm (SD 21.3)
P<0.05 vs Control (no device)



Comparison 21 Containment of urinary incontinence from any cause: external penile compression devices (penile clamps) versus no treatment, Outcome 2 Mean urine loss (grams of urine on pad test).

3 Penile Doppler blood flow (mean systolic velocity) Show forest plot

Other data

No numeric data

Analysis 21.3

Study

Control (no device)

U‐Tex

C3

Cunningham

Moore 2004

N=12 men
R: 12.4 (SD 2.8)
L: 12.3 (SD 3.0)

N=12 men
R: 11.9 (SD 4.4)
L: 13.8 (SD 7.3)

N=12 men
R: 12.4 (SD 5.5)
L: 11.7 (SD 4.7)

N=12 men
R: 9.5 (SD 2.3)
L: 7.3 (SD 3.0)
P<0.05 vs Control (no device)



Comparison 21 Containment of urinary incontinence from any cause: external penile compression devices (penile clamps) versus no treatment, Outcome 3 Penile Doppler blood flow (mean systolic velocity).

4 Penile Doppler blood flow (mean resistence to flow index) Show forest plot

Other data

No numeric data

Analysis 21.4

Study

Control (no device)

U‐Tex

C3

Cunningham

Moore 2004

N=12 men
R: 0.9 (SD 0.1)
L: 0.87 (SD 0.1)

N=12 men
R: 0.93 (SD 0.08)
L: 0.91 (SD 0.11)

N=12 men
R: 0.92 (SD 0.1)
L: 0.92 (SD 0.11)

N=12 men
R: 0.92 (SD 0.13)
L: 0.86 (SD 0.29)



Comparison 21 Containment of urinary incontinence from any cause: external penile compression devices (penile clamps) versus no treatment, Outcome 4 Penile Doppler blood flow (mean resistence to flow index).

PRISMA study flow diagram.
Figuras y tablas -
Figure 1

PRISMA study flow diagram.

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figuras y tablas -
Figure 3

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 1 Number of incontinent men.
Figuras y tablas -
Analysis 1.1

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 1 Number of incontinent men.

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 2 Number of incontinence episodes per day.
Figuras y tablas -
Analysis 1.2

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 2 Number of incontinence episodes per day.

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 3 Number of men using pads.
Figuras y tablas -
Analysis 1.3

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 3 Number of men using pads.

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 4 Pad changes over 24 hours.
Figuras y tablas -
Analysis 1.4

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 4 Pad changes over 24 hours.

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 5 Urinary Incontinence Score (ICIQ‐SF).
Figuras y tablas -
Analysis 1.5

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 5 Urinary Incontinence Score (ICIQ‐SF).

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 6 Quality of life related to urinary incontinence.
Figuras y tablas -
Analysis 1.6

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 6 Quality of life related to urinary incontinence.

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 7 Adverse events.
Figuras y tablas -
Analysis 1.7

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 7 Adverse events.

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 8 24 hour pad test (grams of urine lost).
Figuras y tablas -
Analysis 1.8

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 8 24 hour pad test (grams of urine lost).

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 9 1 hour pad test (grams of urine lost).
Figuras y tablas -
Analysis 1.9

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 9 1 hour pad test (grams of urine lost).

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 10 Number of men not carrying out pelvic floor muscle contractions at 12 months.
Figuras y tablas -
Analysis 1.10

Comparison 1 Treatment of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 10 Number of men not carrying out pelvic floor muscle contractions at 12 months.

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 1 Number of incontinent men.
Figuras y tablas -
Analysis 2.1

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 1 Number of incontinent men.

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 2 Adverse effects.
Figuras y tablas -
Analysis 2.2

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 2 Adverse effects.

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 3 24 hour pad test (grams of urine lost).
Figuras y tablas -
Analysis 2.3

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 3 24 hour pad test (grams of urine lost).

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 4 Urinary Incontinence Score (ICIQ‐short form UI score).
Figuras y tablas -
Analysis 2.4

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 4 Urinary Incontinence Score (ICIQ‐short form UI score).

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 5 Urinary Incontinence Quality of Life Score (ICIQ‐short form).
Figuras y tablas -
Analysis 2.5

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 5 Urinary Incontinence Quality of Life Score (ICIQ‐short form).

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 6 Time until continent (months).
Figuras y tablas -
Analysis 2.6

Comparison 2 Treatment of UI after radical: electric or magnetic energy versus no treatment, Outcome 6 Time until continent (months).

Comparison 4 Treatment of UI after radical: combinations of treatments versus no treatment, Outcome 1 Number of incontinent men at < 3 months.
Figuras y tablas -
Analysis 4.1

Comparison 4 Treatment of UI after radical: combinations of treatments versus no treatment, Outcome 1 Number of incontinent men at < 3 months.

Comparison 4 Treatment of UI after radical: combinations of treatments versus no treatment, Outcome 2 Number of incontinent men within 3‐6 months.
Figuras y tablas -
Analysis 4.2

Comparison 4 Treatment of UI after radical: combinations of treatments versus no treatment, Outcome 2 Number of incontinent men within 3‐6 months.

Comparison 4 Treatment of UI after radical: combinations of treatments versus no treatment, Outcome 3 Number of incontinence episodes per day at > 3 months.
Figuras y tablas -
Analysis 4.3

Comparison 4 Treatment of UI after radical: combinations of treatments versus no treatment, Outcome 3 Number of incontinence episodes per day at > 3 months.

Comparison 4 Treatment of UI after radical: combinations of treatments versus no treatment, Outcome 4 Adverse effects.
Figuras y tablas -
Analysis 4.4

Comparison 4 Treatment of UI after radical: combinations of treatments versus no treatment, Outcome 4 Adverse effects.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 1 Number of incontinent men at < 3 months.
Figuras y tablas -
Analysis 5.1

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 1 Number of incontinent men at < 3 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 2 Number of incontinent men within 3 to 6 months.
Figuras y tablas -
Analysis 5.2

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 2 Number of incontinent men within 3 to 6 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 3 Number of incontinent men within 6 to 12 months.
Figuras y tablas -
Analysis 5.3

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 3 Number of incontinent men within 6 to 12 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 4 Number of incontinence episodes at < 3 months.
Figuras y tablas -
Analysis 5.4

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 4 Number of incontinence episodes at < 3 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 5 Quality of Life Score (severity of UI) within 3 to 6 months.
Figuras y tablas -
Analysis 5.5

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 5 Quality of Life Score (severity of UI) within 3 to 6 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 6 Quality of Life Score (I‐QoL) within 6‐12 months.
Figuras y tablas -
Analysis 5.6

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 6 Quality of Life Score (I‐QoL) within 6‐12 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 7 Quality of Life Score (ICI‐Q‐SF) within 6‐12 months.
Figuras y tablas -
Analysis 5.7

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 7 Quality of Life Score (ICI‐Q‐SF) within 6‐12 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 8 Adverse events.
Figuras y tablas -
Analysis 5.8

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 8 Adverse events.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 9 1 hour pad test (grams of urine lost): at < 3 months.
Figuras y tablas -
Analysis 5.9

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 9 1 hour pad test (grams of urine lost): at < 3 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 10 24 hour pad test (grams of urine lost): at < 3 months.
Figuras y tablas -
Analysis 5.10

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 10 24 hour pad test (grams of urine lost): at < 3 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 11 24 hour pad test (grams of urine lost): within 3 to 6 months.
Figuras y tablas -
Analysis 5.11

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 11 24 hour pad test (grams of urine lost): within 3 to 6 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 12 24 hour pad test (grams of urine lost): within 3 to 6 months.
Figuras y tablas -
Analysis 5.12

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 12 24 hour pad test (grams of urine lost): within 3 to 6 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 13 Pad changes over 24 hours within 3 to 6 months.
Figuras y tablas -
Analysis 5.13

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 13 Pad changes over 24 hours within 3 to 6 months.

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 14 Number of men not carrying out sufficient PFMT within 3 to 6 months.
Figuras y tablas -
Analysis 5.14

Comparison 5 Treatment of UI after radical: one active treatment versus another active treatment, Outcome 14 Number of men not carrying out sufficient PFMT within 3 to 6 months.

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 1 Number of incontinent men.
Figuras y tablas -
Analysis 6.1

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 1 Number of incontinent men.

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 2 Pad changes over 24 hours.
Figuras y tablas -
Analysis 6.2

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 2 Pad changes over 24 hours.

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 3 1 hour pad test (grams of urine lost).
Figuras y tablas -
Analysis 6.3

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 3 1 hour pad test (grams of urine lost).

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 4 24 hour pad test (gm/24hrs).
Figuras y tablas -
Analysis 6.4

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 4 24 hour pad test (gm/24hrs).

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 5 Number of incontinence episodes per day.
Figuras y tablas -
Analysis 6.5

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 5 Number of incontinence episodes per day.

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 6 Urinary Incontinence Score (ICI‐short form).
Figuras y tablas -
Analysis 6.6

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 6 Urinary Incontinence Score (ICI‐short form).

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 7 Quality of Life Score (IIQ).
Figuras y tablas -
Analysis 6.7

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 7 Quality of Life Score (IIQ).

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 8 Pelvic floor muscle strength (anal squeeze pressure, cm H2O).
Figuras y tablas -
Analysis 6.8

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 8 Pelvic floor muscle strength (anal squeeze pressure, cm H2O).

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 9 Number of men not carrying out sufficient PFMT.
Figuras y tablas -
Analysis 6.9

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 9 Number of men not carrying out sufficient PFMT.

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 10 Number of men having surgery for incontinence.
Figuras y tablas -
Analysis 6.10

Comparison 6 Prevention of UI after radical: PFMT ± biofeedback versus no treatment, Outcome 10 Number of men having surgery for incontinence.

Comparison 7 Prevention of UI after radical: electric or magnetic energy versus no treatment, Outcome 1 1 hour pad test (grams of urine lost).
Figuras y tablas -
Analysis 7.1

Comparison 7 Prevention of UI after radical: electric or magnetic energy versus no treatment, Outcome 1 1 hour pad test (grams of urine lost).

Comparison 7 Prevention of UI after radical: electric or magnetic energy versus no treatment, Outcome 2 ICIQ‐SF score.
Figuras y tablas -
Analysis 7.2

Comparison 7 Prevention of UI after radical: electric or magnetic energy versus no treatment, Outcome 2 ICIQ‐SF score.

Comparison 9 Prevention of UI after radical: combinations of treatments versus no treatment, Outcome 1 Number of incontinent men within 3 to 6 months.
Figuras y tablas -
Analysis 9.1

Comparison 9 Prevention of UI after radical: combinations of treatments versus no treatment, Outcome 1 Number of incontinent men within 3 to 6 months.

Comparison 9 Prevention of UI after radical: combinations of treatments versus no treatment, Outcome 2 Number of incontinent men within 6 to 12 months.
Figuras y tablas -
Analysis 9.2

Comparison 9 Prevention of UI after radical: combinations of treatments versus no treatment, Outcome 2 Number of incontinent men within 6 to 12 months.

Comparison 9 Prevention of UI after radical: combinations of treatments versus no treatment, Outcome 3 24 hour pad test (grams of urine lost) within 3 to 6 months.
Figuras y tablas -
Analysis 9.3

Comparison 9 Prevention of UI after radical: combinations of treatments versus no treatment, Outcome 3 24 hour pad test (grams of urine lost) within 3 to 6 months.

Comparison 9 Prevention of UI after radical: combinations of treatments versus no treatment, Outcome 4 24 hour pad test (grams of urine lost) 6 to 12 months.
Figuras y tablas -
Analysis 9.4

Comparison 9 Prevention of UI after radical: combinations of treatments versus no treatment, Outcome 4 24 hour pad test (grams of urine lost) 6 to 12 months.

Comparison 9 Prevention of UI after radical: combinations of treatments versus no treatment, Outcome 5 Time until continent (months).
Figuras y tablas -
Analysis 9.5

Comparison 9 Prevention of UI after radical: combinations of treatments versus no treatment, Outcome 5 Time until continent (months).

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 1 Number of incontinent men at < 3months.
Figuras y tablas -
Analysis 10.1

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 1 Number of incontinent men at < 3months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 2 Number of incontinent men within 3 to 6 months.
Figuras y tablas -
Analysis 10.2

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 2 Number of incontinent men within 3 to 6 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 3 Number of incontinent men within 6 to 12 months.
Figuras y tablas -
Analysis 10.3

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 3 Number of incontinent men within 6 to 12 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 4 Number of incontinent men after 12 months.
Figuras y tablas -
Analysis 10.4

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 4 Number of incontinent men after 12 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 5 No. with severe incontinence (e.g. pad test weight >150g) at < 3 months.
Figuras y tablas -
Analysis 10.5

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 5 No. with severe incontinence (e.g. pad test weight >150g) at < 3 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 6 No. with severe incontinence (e.g. pad test weight >150g) at 3 to 6 months.
Figuras y tablas -
Analysis 10.6

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 6 No. with severe incontinence (e.g. pad test weight >150g) at 3 to 6 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 7 20 minute pad test (grams of urine lost): within 3 to 6 months.
Figuras y tablas -
Analysis 10.7

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 7 20 minute pad test (grams of urine lost): within 3 to 6 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 8 20 minute pad test (grams of urine lost): within 6 to 12 months.
Figuras y tablas -
Analysis 10.8

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 8 20 minute pad test (grams of urine lost): within 6 to 12 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 9 1 hour pad test (grams of urine lost) at less than 3 months.
Figuras y tablas -
Analysis 10.9

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 9 1 hour pad test (grams of urine lost) at less than 3 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 10 1 hour pad test (grams of urine lost) within 3‐6 months.
Figuras y tablas -
Analysis 10.10

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 10 1 hour pad test (grams of urine lost) within 3‐6 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 11 1 hour pad test within 6‐12 months.
Figuras y tablas -
Analysis 10.11

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 11 1 hour pad test within 6‐12 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 12 24 hour pad test (grams of urine lost) at less than 3 months.
Figuras y tablas -
Analysis 10.12

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 12 24 hour pad test (grams of urine lost) at less than 3 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 13 24 hour pad test (grams of urine lost) within 3‐6 months.
Figuras y tablas -
Analysis 10.13

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 13 24 hour pad test (grams of urine lost) within 3‐6 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 14 24 hour pad test (grams of urine lost) within 6‐12 months.
Figuras y tablas -
Analysis 10.14

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 14 24 hour pad test (grams of urine lost) within 6‐12 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 15 Quality of Life Score (ICS male short form) at < 3 months.
Figuras y tablas -
Analysis 10.15

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 15 Quality of Life Score (ICS male short form) at < 3 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 16 Urinary Incontinence Quality of Life Score (ICIQ ‐ short form) within 3‐6 months.
Figuras y tablas -
Analysis 10.16

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 16 Urinary Incontinence Quality of Life Score (ICIQ ‐ short form) within 3‐6 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 17 Urinary Incontinence Quality of Life Score (ICIQ‐short form) within 6‐12 months.
Figuras y tablas -
Analysis 10.17

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 17 Urinary Incontinence Quality of Life Score (ICIQ‐short form) within 6‐12 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 18 King's health Questionnaire after 12 months.
Figuras y tablas -
Analysis 10.18

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 18 King's health Questionnaire after 12 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 19 Health status measure SF‐36 within 3‐6 months.
Figuras y tablas -
Analysis 10.19

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 19 Health status measure SF‐36 within 3‐6 months.

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 20 Adverse events.
Figuras y tablas -
Analysis 10.20

Comparison 10 Prevention of UI after radical: one active treatment versus another active treatment, Outcome 20 Adverse events.

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 1 Number of incontinent men.
Figuras y tablas -
Analysis 11.1

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 1 Number of incontinent men.

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 2 Number of incontinence episodes per day.
Figuras y tablas -
Analysis 11.2

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 2 Number of incontinence episodes per day.

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 3 Number of men using pads.
Figuras y tablas -
Analysis 11.3

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 3 Number of men using pads.

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 4 Urinary Incontinence Score (ICI‐short form).
Figuras y tablas -
Analysis 11.4

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 4 Urinary Incontinence Score (ICI‐short form).

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 5 Quality of life related to urinary incontinence.
Figuras y tablas -
Analysis 11.5

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 5 Quality of life related to urinary incontinence.

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 6 Number of men not carrying out pelvic floor muscle contractions at 12 months.
Figuras y tablas -
Analysis 11.6

Comparison 11 Treatment of UI after TURP: PFMT ± biofeedback versus no treatment, Outcome 6 Number of men not carrying out pelvic floor muscle contractions at 12 months.

Comparison 16 Prevention of UI after TURP:  pre or post‐operative PFMT ± biofeedback versus no treatment, Outcome 1 Number of incontinent men.
Figuras y tablas -
Analysis 16.1

Comparison 16 Prevention of UI after TURP:  pre or post‐operative PFMT ± biofeedback versus no treatment, Outcome 1 Number of incontinent men.

Comparison 16 Prevention of UI after TURP:  pre or post‐operative PFMT ± biofeedback versus no treatment, Outcome 2 Health status measure SF‐36 within 3‐6 months.
Figuras y tablas -
Analysis 16.2

Comparison 16 Prevention of UI after TURP:  pre or post‐operative PFMT ± biofeedback versus no treatment, Outcome 2 Health status measure SF‐36 within 3‐6 months.

Study

Control (no device)

U‐Tex

C3

Cunningham

Moore 2004

0/12

0/12

2/12

10/12

Figuras y tablas -
Analysis 21.1

Comparison 21 Containment of urinary incontinence from any cause: external penile compression devices (penile clamps) versus no treatment, Outcome 1 Number of men satisfied with device.

Study

Control (no device)

U‐Tex

C3

Cunningham

Moore 2004

122.8 gm (SD 130.8)

53.3 gm (SD 65.7)
P<0.05 vs Control (no device)

32.3 gm (SD 24.3)
P<0.05 vs Control (no device)

17.1 gm (SD 21.3)
P<0.05 vs Control (no device)

Figuras y tablas -
Analysis 21.2

Comparison 21 Containment of urinary incontinence from any cause: external penile compression devices (penile clamps) versus no treatment, Outcome 2 Mean urine loss (grams of urine on pad test).

Study

Control (no device)

U‐Tex

C3

Cunningham

Moore 2004

N=12 men
R: 12.4 (SD 2.8)
L: 12.3 (SD 3.0)

N=12 men
R: 11.9 (SD 4.4)
L: 13.8 (SD 7.3)

N=12 men
R: 12.4 (SD 5.5)
L: 11.7 (SD 4.7)

N=12 men
R: 9.5 (SD 2.3)
L: 7.3 (SD 3.0)
P<0.05 vs Control (no device)

Figuras y tablas -
Analysis 21.3

Comparison 21 Containment of urinary incontinence from any cause: external penile compression devices (penile clamps) versus no treatment, Outcome 3 Penile Doppler blood flow (mean systolic velocity).

Study

Control (no device)

U‐Tex

C3

Cunningham

Moore 2004

N=12 men
R: 0.9 (SD 0.1)
L: 0.87 (SD 0.1)

N=12 men
R: 0.93 (SD 0.08)
L: 0.91 (SD 0.11)

N=12 men
R: 0.92 (SD 0.1)
L: 0.92 (SD 0.11)

N=12 men
R: 0.92 (SD 0.13)
L: 0.86 (SD 0.29)

Figuras y tablas -
Analysis 21.4

Comparison 21 Containment of urinary incontinence from any cause: external penile compression devices (penile clamps) versus no treatment, Outcome 4 Penile Doppler blood flow (mean resistence to flow index).

Summary of findings for the main comparison. Treatment of UI after radical: PFMT ± biofeedback versus no treatment; for postprostatectomy urinary incontinence

Treatment of UI after radical: PFMT ±biofeedback versus no treatment; for postprostatectomy urinary incontinence

Patient or population: patients with postprostatectomy urinary incontinence
Intervention: treatment of UI after radical: PFMT ± biofeedback versus no treatment

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Treatment of UI after radical: PFMT ±biofeedback versus no treatment

Number of incontinent men ‐ after 12 months

623 per 1000

529 per 1000
(374 to 760)

RR 0.85
(0.6 to 1.22)

665
(3 studies)

⊕⊕⊕⊝
moderate1,2

Urinary Incontinence Score (ICI‐SF) ‐ after first year

The mean urinary incontinence score (ici‐short form) ‐ after first year in the intervention groups was
0.5 lower
(1.35 lower to 0.35 higher)

391
(1 study)

⊕⊕⊝⊝
low2,3,4

Adverse events

See comment

See comment

Not estimable

138
(1 study)

⊕⊕⊕⊕
high2,3,5

Economic analysis using QALY ‐ not reported

See comment

See comment

Not estimable

See comment

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Wide CI (0.60 to 1.22)
2 Funnel plot could not be used as there are fewer than 10 trials
3 Not applicable (only one trial)
4 95% CI is very wide (‐1.35 to 0.35)
5 Not estimable as the event rate is zero in each arm

Figuras y tablas -
Summary of findings for the main comparison. Treatment of UI after radical: PFMT ± biofeedback versus no treatment; for postprostatectomy urinary incontinence
Summary of findings 2. Treatment of UI after radical: electric or magnetic energy versus no treatment for postprostatectomy urinary incontinence

Treatment of UI after radical: electric or magnetic energy versus no treatment for postprostatectomy UI

Patient or population: Patients with postprostatectomy UI
Intervention: Treatment of UI after radical: electric or magnetic energy versus no treatment

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Treatment of UI after radical: electric or magnetic energy versus no treatment

Number of incontinent men ‐ after 12 months

63 per 1000

16 per 1000
(6 to 47)

RR 0.26
(0.09 to 0.74)

413
(3 studies)

⊕⊕⊕⊝
moderate1,2

Urinary Incontinence Score (ICIQ‐SF UI score) ‐ after 12 months

The mean urinary incontinence score (iciq‐short form ui score) ‐ after 12 months in the intervention groups was
1.4 lower
(5.03 lower to 2.23 higher)

47
(1 study)

⊕⊕⊝⊝
low2,3,4

Urinary Incontinence Quality of Life Score (ICIQ‐SF) ‐ after 12 months

See comment

See comment

Not estimable

47
(1 study)

⊕⊕⊝⊝
low2,3,5

Adverse events

133 per 1000

77 per 1000
(15 to 387)

RR 0.58
(0.11 to 2.9)

56
(1 study)

⊕⊕⊝⊝
low2,3,6

Economic analysis using QALY ‐ not reported

See comment

See comment

Not estimable

See comment

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Random sequence generation and allocation concealment unclear is 1/2 trials taking part in the meta‐analysis
2 Funnel plot could not be used as there are fewer than 10 trials
3 Not applicable. Only one trial
4 95% CI very wide (‐5.03 to 2.23)
5 95% CI very wide (‐2.02 to 1.22)
6 95% CI very wide (0.11 to 2.90)

Figuras y tablas -
Summary of findings 2. Treatment of UI after radical: electric or magnetic energy versus no treatment for postprostatectomy urinary incontinence
Summary of findings 3. Treatment of UI after radical: combinations of treatments versus no treatment for postprostatectomy urinary incontinence

Treatment of UI after radical: combinations of treatments versus no treatment for postprostatectomy UI

Patient or population: patients with postprostatectomy UI
Intervention: Treatment of UI after radical: combinations of treatments versus no treatment

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Treatment of UI after radical: combinations of treatments versus no treatment

Number of incontinent men with 3 to 6 months

53 per 1000

150 per 1000
(17 to 1000)

RR 2.85
(0.32 to 25.07)

39
(1 study)

⊕⊝⊝⊝
very low1,2,3,4

Urinary Incontinence Quality of Life Score (ICIQ‐SF) after 12 months

Study population

Not estimable

0
(0)

See comment

See comment

See comment

Moderate

Adverse events ‐ PFMT + anal EStim + BFB

0 per 1000

0 per 1000
(0 to 0)

RR 4.86
(0.24 to 99.39)

138
(1 study)

⊕⊕⊝⊝
low2,4,5

Economic Analysis using QALY ‐ not reported

See comment

See comment

Not estimable

See comment

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Random sequence generation and allocation concealment unclear
2 Not applicable, only one trial
3 No explanation was provided
4 Funnel plot cannot be used as there is only one trial
5 95% CI is very wide (0.24 to 99.39)

Figuras y tablas -
Summary of findings 3. Treatment of UI after radical: combinations of treatments versus no treatment for postprostatectomy urinary incontinence
Summary of findings 4. Treatment of UI after radical: one active treatment versus another active treatment for postprostatectomy urinary incontinence

Treatment of UI after radical: one active treatment versus another active treatment for postprostatectomy UI

Patient or population: Patients with postprostatectomy UI
Intervention: Treatment of UI after radical: one active treatment versus another active treatment

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Treatment of UI after radical: one active treatment versus another active treatment

Number of incontinent men within 6 to 12 months ‐ FES versus ExMI

83 per 1000

167 per 1000
(17 to 1000)

RR 2
(0.21 to 19.23)

24
(1 study)

⊕⊝⊝⊝
very low1,2,3,4,5

Quality of Life Score (ICI‐Q‐SF) within 6 to 12 months ‐ PFMT + ExMI versus PFMT

The mean quality of life score (ICI‐Q‐SF) within 6 to 12 months ‐ PFMT + ExMI versus PFMT in the intervention groups was
1.6 lower
(2.73 to 0.47 lower)

24
(1 study)

⊕⊕⊝⊝
low1,2,5,6

Adverse events PFMT + Anal EStim versus PFMT alone

0 per 1000

0 per 1000
(0 to 0)

RR 5
(0.24 to 102.3)

140
(1 study)

⊕⊕⊝⊝
low2,5,7

Economic analysis using QALY

Study population

Not estimable

0
(0)

See comment

See comment

See comment

Moderate

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Random sequence generation and allocation concealment is unclear
2 Not applicable, only one trial
3 GRADE‐specific outcome was number of incontinent men after 12 months
4 95% CI is very wide (0.21 to 19.23)
5 Funnel plot cannot be used as there was only one trial
6 GRADE‐specific outcome was ICI‐Q‐SF after 12 months
7 95% CI very wide (0.24 to 102.30)

Figuras y tablas -
Summary of findings 4. Treatment of UI after radical: one active treatment versus another active treatment for postprostatectomy urinary incontinence
Summary of findings 5. Prevention of UI after radical: PFMT ± biofeedback versus no treatment for postprostatectomy urinary incontinence

Prevention of UI after radical: PFMT ±biofeedback versus no treatment compared to for UI

Patient or population: All men after radical prostatectomy
Intervention: Prevention of UI after radical: PFMT ± biofeedback versus no treatment
Comparison:

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Prevention of UI after radical: PFMT ±biofeedback versus no treatment

Number of incontinent men ‐ after 12 months

321 per 1000

103 per 1000
(64 to 164)

RR 0.32
(0.2 to 0.51)

373
(2 studies)

⊕⊕⊕⊝
moderate1,2

Quality of life score assessed using (ICI‐SF UI score) ‐ within 6 to 12 months

The mean quality of life score assessed using (ICI‐SF UI score) ‐ within 6 to 12 months in the intervention groups was
0.69 lower
(3.19 lower to 1.81 higher)

105
(2 studies)

⊕⊝⊝⊝
very low2,3,4

Adverse events ‐ not reported

See comment

See comment

Not estimable

See comment

Economic analysis using QALY ‐ not reported

See comment

See comment

Not estimable

See comment

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Allocation concealment is unclear for Filocamo 2005 which contributes 84.2% weightage
2 Funnel plot cannot be used as there are fewer than 10 trials
3 Sequence generation is unclear in Ribeiro 2008. Allocation concealment is unclear in both the trials taking part in the meta‐analysis
4 95% CI is very wide (‐3.19 to 1.81)

Figuras y tablas -
Summary of findings 5. Prevention of UI after radical: PFMT ± biofeedback versus no treatment for postprostatectomy urinary incontinence
Summary of findings 6. Prevention of UI after radical: electric or magnetic energy versus no treatment for postprostatectomy urinary incontinence

Prevention of UI after radical: electric or magnetic energy versus no treatment for UI

Patient or population: All men after radical prostatectomy
Intervention: Prevention of UI after radical: electric or magnetic energy versus no treatment

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Prevention of UI after radical: electric or magnetic energy versus no treatment

Number of incontinent men after 12 months ‐ not reported

See comment

See comment

Not estimable

See comment

Quality of life score assessed using (ICIQ‐SF score) ‐ within 6 to 12 months

See comment

See comment

Not estimable

32
(1 study)

⊕⊝⊝⊝
very low1,2,3

Adverse events ‐ not reported

See comment

See comment

Not estimable

See comment

Economic analysis using QALY ‐ not reported

See comment

See comment

Not estimable

See comment

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Allocation concealment is unclear
2 95% CI is very wide (‐2.15 to 5.35)
3 Funnel plot cannot be used as there are fewer than 10 trials

Figuras y tablas -
Summary of findings 6. Prevention of UI after radical: electric or magnetic energy versus no treatment for postprostatectomy urinary incontinence
Summary of findings 7. Prevention of UI after radical: combinations of treatments versus no treatment for postprostatectomy urinary incontinence

Prevention of UI after radical: combinations of treatments versus no treatment compared to for postprostatectomy UI

Patient or population: All men after radical prostatectomy
Intervention: Prevention of UI after radical: combinations of treatments versus no treatment

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Prevention of UI after radical: combinations of treatments versus no treatment

Number of incontinent men within 6 to 12 months ‐ PFMT + anal EStim + biofeedback versus no treatment

See comment

See comment

Not estimable

60
(1 study)

⊕⊕⊝⊝
low1,2

Quality of life Score assessed using (ICIQ‐SF) or (ICIQ‐ SF UI score) ‐ not reported

See comment

See comment

Not estimable

See comment

Adverse events ‐ not reported

See comment

See comment

Not estimable

See comment

Economic analysis using QALY ‐ not reported

See comment

See comment

Not estimable

See comment

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Sequence generation and allocation concealment are both unclear
2 Funnel plot cannot be used as there are fewer than 10 trials

Figuras y tablas -
Summary of findings 7. Prevention of UI after radical: combinations of treatments versus no treatment for postprostatectomy urinary incontinence
Summary of findings 8. Prevention of UI after radical: one active treatment versus another active treatment (PFMT pre and post‐operation versus PFMT post‐operation) for postprostatectomy urinary incontinence

Prevention of UI after radical: one active treatment versus another active treatment compared to (PFMT pre and post‐operation versus PFMT post‐operation) for UI

Patient or population: All men after radical prostatectomy
Intervention: Prevention of UI after radical: one active treatment versus another active treatment
Comparison: (PFMT pre and post‐operation versus PFMT post‐operation)

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

(PFMT pre and post‐operation versus PFMT post‐operation)

Prevention of UI after radical: one active treatment versus another active treatment

Number of incontinent men after 12 months

See comment

See comment

Not estimable

367
(3 studies)

⊕⊕⊕⊝
moderate1,2

Quality of Life Score assessed using (ICIQ‐SF) or (ICIQ‐SF UI score) after 12 months ‐ not reported

See comment

See comment

Not estimable

See comment

Adverse events

See comment

See comment

Not estimable

102
(1 study)

⊕⊕⊕⊕
high3,4,5

Economic Analysis using QALY ‐ not reported

See comment

See comment

Not estimable

See comment

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Sequence generation is unclear 2/3 trials and allocation concealment is unclear in 1/3 trials
2 Due to clinical heterogeneity we decided not to pool the results
3 Not applicable
4 RR is not estimable as there is zero event in both arms of the trial
5 Funnel plot cannot be used as there were fewer than 10 trials

Figuras y tablas -
Summary of findings 8. Prevention of UI after radical: one active treatment versus another active treatment (PFMT pre and post‐operation versus PFMT post‐operation) for postprostatectomy urinary incontinence
Summary of findings 9. Prevention of UI after radical: one active treatment versus another active treatment (PFMT + penile vibration pre and post‐operation versus PFMT pre and post‐operation) for postprostatectomy urinary incontinence

Prevention of UI after radical: one active treatment versus another active treatment compared to (PFMT + penile vibration pre and post‐operation versus PFMT pre and post‐operation) for

Patient or population: All men after radical prostatectomy
Intervention: Prevention of UI after radical: one active treatment versus another active treatment
Comparison: PFMT + penile vibration pre and post‐operation versus PFMT pre and post‐operation)

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

(PFMT + penile vibration pre and post‐operation versus PFMT pre and post‐operation)

Prevention of UI after radical: one active treatment versus another active treatment

Number of incontinent men after 12 months

71 per 1000

100 per 1000
(18 to 555)

RR 1.4
(0.25 to 7.77)

58
(1 study)

⊕⊕⊝⊝
low1,2,3

Quality of life Score assessed using (ICIQ‐SF) or (ICIQ‐SF UI score)

Study population

Not estimable

0
(0)

See comment

See comment

See comment

Moderate

Adverse events

See comment

See comment

Not estimable

68
(1 study)

⊕⊕⊝⊝
low1,3,4

Economic analysis using QALY ‐ not reported

See comment

See comment

Not estimable

See comment

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Not applicable
2 95% CI very wide (0.25 to 7.77)
3 Funnel plot cannot be used as there were fewer than 10 trials
4 95% CI is very wide (0.80 to 240.77)

Figuras y tablas -
Summary of findings 9. Prevention of UI after radical: one active treatment versus another active treatment (PFMT + penile vibration pre and post‐operation versus PFMT pre and post‐operation) for postprostatectomy urinary incontinence
Summary of findings 10. Prevention of UI after radical: one active treatment versus another active treatment (pre‐operative PFMT + electrical stimulation versus pre‐operative PFMT) for postprostatectomy urinary incontinence

Prevention of UI after radical: one active treatment versus another active treatment compared to (pre‐operative PFMT + electrical stimulation versus pre‐operative PFMT) for UI

Patient or population: All men after radical prostatectomy
Intervention: Prevention of UI after radical: one active treatment versus another active treatment
Comparison: Pre‐operative PFMT + electrical stimulation versus pre‐operative PFMT

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

(pre‐operative PFMT + electrical stimulation versus pre‐operative PFMT)

Prevention of UI after radical: one active treatment versus another active treatment

Number of incontinent men after 12 months ‐ not reported

See comment

See comment

Not estimable

See comment

Quality of Life Score assessed using (ICIQ‐SF) within 6 to 12 months

See comment

See comment

Not estimable

34
(1 study)

⊕⊝⊝⊝
very low1,2,3,4

Adverse events ‐ not reported

See comment

See comment

Not estimable

See comment

Economic analysis using QALY ‐ not reported

See comment

See comment

Not estimable

See comment

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Allocation concealment is unclear
2 Not applicable
3 95% CI very wide (‐3.13 to 4.13)
4 Funnel plot cannot be used as there were fewer than 10 trials

Figuras y tablas -
Summary of findings 10. Prevention of UI after radical: one active treatment versus another active treatment (pre‐operative PFMT + electrical stimulation versus pre‐operative PFMT) for postprostatectomy urinary incontinence
Summary of findings 11. Treatment of UI after TURP: PFMT ± biofeedback versus no treatment for postprostatectomy urinary incontinence

Treatment of UI after TURP: PFMT ±biofeedback versus no treatment compared to for UI

Patient or population: Men with UI after TURP
Intervention: Treatment of UI after TURP: PFMT ± biofeedback versus no treatment

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Treatment of UI after TURP: PFMT ±biofeedback versus no treatment

Number of incontinent men‐ after 12 months

See comment

See comment

Not estimable

1609
(1 study)

⊕⊕⊕⊝
moderate1,2,3

Quality of life Score assessed using Score (ICIQ‐SF UI score) ‐ after 12 months

See comment

See comment

Not estimable

397
(1 study)

⊕⊕⊝⊝
low1,3,4

Adverse events ‐ not reported

See comment

See comment

Not estimable

See comment

Economic analysis using QALY ‐ not reported

See comment

See comment

Not estimable

See comment

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Not applicable
2 95% CI is wide (0.91 to 1.23)
3 Funnel plot cannot be used at there are fewer than 10 trials
4 95% CI is very wide (‐0.89 to 0.69)
5 GRADE specific outcome is IIEF score
6 95% CI is very wide (0.86 to 1.72)

Figuras y tablas -
Summary of findings 11. Treatment of UI after TURP: PFMT ± biofeedback versus no treatment for postprostatectomy urinary incontinence
Summary of findings 12. Prevention of UI after TURP:  pre or post‐operative PFMT ± biofeedback versus no treatment for postprostatectomy urinary incontinence

Prevention of UI after TURP:  pre or post‐operative PFMT ±biofeedback versus no treatment for UI

Patient or population: All men after TURP
Intervention: Prevention of UI after TURP: pre or post‐operative PFMT ± biofeedback versus no treatment

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Prevention of UI after TURP:  pre or post‐operative PFMT ±biofeedback versus no treatment

Number of incontinent men ‐ within 3 to 6 months

227 per 1000

116 per 1000
(32 to 430)

RR 0.51
(0.14 to 1.89)

48
(1 study)

⊕⊝⊝⊝
very low1,2,3,4

Urinary Incontinence Score assessed using (ICIQ‐SF) or (ICIQ‐SF UI score) at 12 months ‐ not reported

See comment

See comment

Not estimable

See comment

Adverse events ‐ not reported

See comment

See comment

Not estimable

See comment

Economic analysis using QALY ‐ not reported

See comment

See comment

Not estimable

See comment

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Not applicable
2 GRADE specific outcome was number of incontinent men after 12 months
3 95% CI is very wide (0.14 to 1.89)
4 Funnel plot cannot be used as there are fewer than 10 trials

Figuras y tablas -
Summary of findings 12. Prevention of UI after TURP:  pre or post‐operative PFMT ± biofeedback versus no treatment for postprostatectomy urinary incontinence
Table 1. Details of interventions

Study ID

Intervention

Control

Ahmed 2012

A: At catheter removal received standard care of verbal and written instructions, instructed by physiotherapist to perform 3 sets of 15‐20 contractions daily, for a duration of 3‐5 seconds with a 6‐10 second rest period, encouraged to perform exercises before functional activities such as sneezing, coughing, or lifting weight, also in the supine position, sitting, squatting and going up and down stairs

 

B: ES, treatment started one week after catheter removal, patients received 15 minutes of twice weekly electrical stimulation for 12 weeks

 

C: PFMT + BFB + ES: Treatment started one week after catheter removal, patients received twice weekly treatment with 15 minutes of electrical stimulation and 15 minutes of biofeedback for 12 weeks, instructed to perform 3 series of 10 rapid contractions, 3 sustained contractions of 5, 7 or 10 seconds and then 10 contractions during prolonged expiration in the supine position

 

All patients were given a logbook to complete daily regarding self‐report of exercises   

Bales 2000

PFMT + biofeedback

45 minute session with nurse trained in biofeedback. Patients were instructed to perform graded PFMT. Contractions of 5‐10 seconds, 10‐15 repetitions were performed with biofeedback (surface electrodes used to measure muscle strength). Advised to practice the exercises 4 times per day until surgery

No biofeedback training

Written and brief verbal instructions from a nurse on how to perform PFMT (isolate muscle that stops urine flow, practice 4 times per day, 10‐15 repetitions).

Burgio 2006

PFMT + biofeedback

Single session of biofeedback (rectal probe to measure intra‐abdominal rectal pressure and external anal sphincter contraction) assisted behavioural training. Feedback and verbal instruction used to teach control of pelvic muscles. Taught to contract sphincter during 2‐10 seconds periods separated by 2‐10 seconds of relaxation, dependent on ability.

Written instructions for daily at home practice of 45 PFM exercises daily (3 sessions of 15 exercises each time). Additionally instructed to slow or interrupt voiding once daily. Encouraged to exercise daily preoperatively, then resume when catheter removed post‐operatively

Usual care of brief verbal instructions post operatively to interrupt the voiding stream plus any instruction from physician.

Centemero 2009

Intervention A: PFMT both pre and post‐operatively. A structured PFMT program 30 and 15 days before surgery, previous physiotherapist evaluation to provide the patients with feedback about the quality of pelvic floor muscle function, PC teste (endurance and contraction quality), breathing coordination, typify muscle contraction as tonic and modify incorrect physical attitudes. This was also repeated after the procedure

Intervention B: PFMT post‐operatively only

Dijkstra‐Eshuis 2013

30 mins of guided PFMT + biofeedback weekly for 4 weeks before surgery, received written instructions to: carry out two sets of 30 contractions during abdominal breathing, one breath between each contraction; restart PFMT after catheter removal (7‐10 days after surgery)

All men were seen before surgery by a physiotherapist, who explained relevant anatomy, anal visual inspection and digital palpation, biofeedback registration with rectal probe, All patients received PFMT + biofeedback or electrical stimulation, or both, if still incontinent after 6 weeks

Received written instructions on PFMT after catheter removal (7‐10 days after surgery)

Dubbelman 2004

Nine or less sessions of physiotherapy guided pelvic floor exercises after surgery

Exercise instruction through information folder

Filocamo 2005

Formal instruction (3 treatment sessions plus at home exercises) in PFMT using verbal explanation, palpation and visualization of the base of the penis with a mirror, in different positions and prior to sneezing, coughing or lifting

No formal instruction

Floratos 2002

Initiated after catheter removal, 15 treatment sessions (3 times per week for 30 minutes) of PFMT with EMG (surface) biofeedback in clinic

Instruction with verbal feedback and an information pamphlet with instructions to perform PFMT 50‐100 times daily at home

Fode 2014

Pre‐operative session guided PFMT + instruction on how to use penile vibratory stimulation device. Instructed to stimulate frenulum once daily, 10 seconds of stimulation then 10 second pause, repeated 10 times for 1 week pre‐operatively, instructed to restart stimulation after catheter removal for 6 weeks

All men were offered a PDE5 inhibitor after 1 month post‐operatively and also received telephone contact to ensure compliance with treatment 

Preoperative session guided PFMT

Franke 1998

Biofeedback (perineal patch EMG) enhanced PFMT; exercise treatment sessions at 6, 7, 9, 11, and 16 weeks post‐operatively

No treatment.

Geraerts 2013

Intervention A: PFMT + biofeedback

30 mins of guided PFMT + biofeedback weekly for 3 weeks before surgery. Patients were instructed to carry out 60 contractions a day at home; contract their pelvic floor while coughing, and sitting down or getting up from a chair. Patients were also instructed to restart PFMT on day 4 after surgery while catheter was in situ

Intervention B: Instructed to start PFMT on the day after catheter removal (e.g. 2‐3 weeks after surgery)

All men: Received weekly individual guided exercise programme with digital or EMG biofeedback after surgery. Advice was given on how to contract pelvic floor muscles to prevent leakage during functional activities. When patients carried out the instructed 60 contractions, they were asked to colour in three squares in their diary to assess compliance

Ghanem 2013

Pre‐operative PFMT for 2 weeks + postoperative PFMT programme      

Postoperative PFMT programme only

Goode 2009

Intervention A: Behavioural therapy with PFMT for 8 weeks

Intervention B: Behavioural therapy with biofeedback and electrical stimulation for 8 weeks

Behavioural therapy consisted of pelvic floor muscle exercises and bladder control strategies in both groups

No treatment

Hoffman 2005

Intervention A: perineal EStim plus physiotherapy (PFMT)

Intervention B: anal EStim plus physiotherapy (PFMT)

PFMT alone

Hou 2013

Guided PFMT + biofeedback after catheter removal (2 days post‐operatively), instructed to: contract pelvic muscles for 5 seconds and relax for 10 seconds. After discharge, patients were instructed to carry out 5 mins of each PFE three times daily. Patients also received motivational telephone interviews once weekly

No description

Joseph 2000

Intervention A: Instruction in PFMT including biofeedback with visual feedback as well as verbal to assist in identifying and discriminating muscles

Intervention B: Instruction in PFMT, squeezing of finger during digital rectal examination

Koo 2009

ExMI, treatment sessions were for 20 minutes twice weekly for 8 weeks

PFMT alone

Laurienzo 2013

A (15): Standard treatment with verbal instructions for PFMT

B (17): Pre‐operative guided PFMT, with 10 physiotherapy sessions: contractions of the pelvic floor muscles for 5 seconds in “dorsal decubitus” position for 10 times, in the same position with the waist elevated (10 times), lying down with legs adducted against a plastic ball performed 10 times and standing and flexing the hips to 60̊ (10 times)

C (17): Pre‐operative PFMT + ES during 10 physiotherapy sessions, ES was with an anal probe lasting 15 minutes in total, and men also received guided PFMT and followed the same training regime as above

Men did not receive treatment post‐operatively

Instructed to start PFMT at home 15 weeks before surgery.

Liu 2008

Extra‐corporeal magnetic innervation (ExMI), the frequency of the pulse field was 10Hz for 10 minutes, followed by a 3 minute rest and a second treatment of 50 Hz for 20 minutes. This was done twice a week

PFMT alone, instructions given to carry out 20mins x 3 a day.

Manassero 2007

PFMT re‐education program, verbal feedback

The training program involved active PFE. verbal feedback of the contraction was used to instruct the patients to correctly and selectively contract their pelvic muscles while relaxing the abdominal muscles. the strength of the pelvic floor muscles was measured by digital anal control using a score of 0 to 5 ( 0 = no contraction, 5 = good contraction against strong resistance)

Initially home practice comprised 45 contractions (3 sessions of 15) per day at home, progressively increasing the number until 90 per day. This was taught by two experienced urologists

No treatment.

Marchiori 2010

Guided PFMT + biofeedback during first session, second session involved 10 sets of pelvic floor electrical stimulation lasting 15 mins each, instructed to: carry out three sets of 30 contractions a day at home for the first month after catheter removal (16 days after surgery)

All men received oral and written information on pelvic floor anatomy and on PFME, pelvic floor muscle endurance assessed by digital anal control

Received oral and written information on pelvic floor anatomy and on PFME, instructed to: perform 30 contractions a day at home for the first month after catheter removal (16 days after surgery)

Mariotti 2009

PFMT plus ES and biofeedback twice a week for 6 weeks

ES ‐ a surface electrodes was inserted into the anus and pulsed, the intensity was adequate to induce visual lifting of the levator ani and pubococcygeus muscle, considering the level of comfort to the patient

Biofeedback ‐ via surface electrodes both perineal and abdominally

Instructions to conduct PFMT ‐ verbal and written instructions at catheter removal and follow up visits.

Martini 2011

PFMT: 5 sessions of guided PFMT for 2‐3 weeks pre‐operatively and continued post‐operatively

All men underwent clinical examination of pelvic muscles function using digital perineal testing according to “AIPDA score” and evaluation of voiding symptoms

Postoperative standard care, written instructions for PFMT

Mathewson‐Chapman 97

Pre‐operatively received further instruction and practice with PME protocol Home exercises and biofeedback (anal probe) (Incare 8900); practiced at home 3 times a week, starting with daily 15 PFMT and increasing by 10 every 4 weeks to a maximum of 35 PFMT.

Post‐operatively no further interventions until week 5 when pelvic muscle strength was assessed.

Moore 1999

Intervention A: PFMT alone

Intervention B: PFMT plus rectal ES treated by one physiotherapist 30 minutes twice a week for 12 weeks

Both included home exercises 3x/day gradually working up to 30 minutes per session lying, standing, sitting; strength, endurance, speed and control with maximum contractions of 5‐10 seconds, 10‐20 second relaxation and 12‐20 repetitions; submaximum contractions at 65‐75% of maximum strength with hold 20‐30 seconds and equal rest time, 8‐10 repetitions; speed was sets of quick repetitive contractions in a 10 second time span; control involved gradual recruitment to maximum contraction in 3 stages with 5 second hold at each stage and a slow release with rest 15‐30 seconds

oral and written information about PFMT pre and post‐ operatively (standard treatment)

Moore 2004

Each participant had 4 periods (each lasted 1 day)
Group A: No device
Group B: C3 device
Group C: U‐Tex device
Group D: Cunningham clamp

Moore 2008

Maximum 24 weekly, 30‐minute treatment protocol (30 min biofeedback‐assisted PFMT) and home exercise protocol of 2‐3 times a day

Verbal and written information on PFME and weekly telephone contact by a urology nurse

Morihiro 2011

 PFMT + sacral surface therapeutic electrical stimulation (ssTES), ssTES 2x a day for 15 minutes each, lasting 1 month after catheter removal (day 5)

PFME only, carried out alone

Nowak 2007

Extra‐corporeal magnetic innervation (EXMI) based pelvic floor device

PFMT alone

Opsomer 1994;

PFMT plus biofeedback plus electrical stimulation directed by physiotherapist

PFMT on their own without medical supervision.

Overgard 2008;

Instructions on PFMT and physiotherapy, 45 minutes weekly

Patients were instructed to perform 3 sets of contractions daily at home, in either a supine, sitting or standing position. Digital anal palpation to teach correct contractions, as well as oral and written instructions

DVD of instructions given to those living too far from hospital

Instructions on PFMT alone.

Parekh 2003

Two treatment sessions preoperatively. Session 1 consisted of PFMT in a hook lying position
Session 2 was on an exercise ball. Teaching methods varied and included verbal cues, visualization with an anatomical model, palpation or biofeedback with rectal probe. Post‐operatively, PFMT was reviewed and participants were seen every 3 weeks for 3 months by a physiotherapist
Home exercise for 6 months or more for those requiring further physical therapy guidance

No formal education on PFMT pre‐operatively, telephone or face to face follow‐up at least monthly.

Park 2012

Patients performed Kegel exercises together with other types of exercises which included resistance training and pelvic flexibility. The intervention started 3 weeks after surgery and lasted 12 weeks

Details of the combined exercise regime:

Post‐operative weeks 1‐4

1) Education about postoperative symptoms

2) Performing Kegel exercises, recognizing the parapelvic muscles

3) Pelvic floor flexibility fitness: performing pelvic exercises while sitting on a ball

Post‐operative weeks 5‐8 (ball exercises)

1) Performing pelvic exercises while sitting on a ball

2) Performing lower extremity exercises while placing a ball on the wall

3) Lifting a heel on the ball while standing face‐to‐face with the wall

4) Lifting up and down on the ball while spreading and bending legs

5) Performing flank exercises while having a ball in the hand

6) Squeezing the ball with the adductor muscles while lying on a table

Post‐operative weeks 9‐12 (elastic band exercises)

1)  Lifting the object with an elastic band lateral, anterior, and posterior to the patient’s arms

2) Lifting the legs and then spreading them while attaching an elastic band to the foot

In the control group, only Kegel exercises were performed

Perissinotto 2008

Early pelvic floor rehabilitation program at home twice dally, Kegel exercises

No formal PFMT

Porru 2001

Initial visit before surgery, digital evaluation of pelvic muscle contraction strength. Verbal instruction, feedback and reinforcement on contraction was given to teach selective contraction of anal sphincter and relaxation of abdominal muscles. Verbal and written instruction given for home PFMT. Weekly digital anal reassessment and grading of pelvic muscle contraction by the therapist. Instructed to practice contractions 45 times per day (3 groups of 15 contractions)

Not specified

Ribeiro 2008

PFMT plus BF weekly for 3 months

PFMT oral instructions only

Robinson 2008

Intervention A: Brief verbal instruction in PFMT before operation and offer of one biofeedback session at 2 months after surgery (uptake 33%) plus PFMT for four weeks with biofeedback

Intervention B: Brief verbal instruction in PFMT before operation and offer of one biofeedback session at 2 months after surgery (uptake 46%)

Robinson 2009

Intervention A: routine brief verbal and written PFMT plus one PFMT session and 3 weekly nurse phone calls

Intervention B: routine brief verbal and written PFMT plus four BF enhanced PFMT sessions and 4 weekly nurse phone calls

Routine brief verbal and written PFMT.

Seleme 2008

Verbal instruction and information on PFMT plus information on life style changes. Additional 15 physiotherapy sessions consisting of intensive PFMT with BF and ES

Verbal instruction and information on PFMT plus information on life style changes.

Tibaek 2007

One hour individual session with physiotherapist to teach correct contraction for PFMT, three 1 hour group lessons and home training programme

No pre operative physiotherapy. Information about anatomy and physiology and verbal instructions for 2 to 3 days after TURP in the ward.

Tienforti 2012

PFMT + biofeedback

Patients received guided PFMT + biofeedback + information about the anatomy of pelvic floor muscles the day before surgery and after catheter removal. They were also given oral and written instructions on Kegel exercises to be performed at home which involved three sets of contractions daily for 10 mins, contracting their pelvic floor while lying, sitting and standing. The frequency of contractions was recorded in a training diary and visits at monthly intervals after catheter removal involved assisted biofeedback and motivation for 20 min

No biofeedback training

Received standard care, oral and written instructions from urologist on PFMT, Instructed to: start PFMT after catheter removal (e.g. 2‐3 weeks after surgery)

Tobia 2008

PFMT

No PFMT

van Kampen 1998

1 session of PFMT in hospital before discharge and then saw the physiotherapist for 1‐2 weeks for as long as UI persisted. 90 daily home exercises sitting, standing and lying. 7 men unable to contract PFM or with weak contraction received electrical stimulation by anal probe

No formal PFMT instruction but saw the therapist at 1‐2 weeks and received placebo stimulation and information about aetiology of UI.

Wille 2003

Intervention A: PFMT alone

Intervention B: PFMT + ES; PFMT as above plus instructed by dedicated in ES via surface anal electrode and bio‐impulser (biphasic pulse with 1 second bursts, 5 second pulse width, 2 second pulse trains

Intervention C: PFMT + ES + biofeedback. As above plus biofeedback (anal probe) 15 minutes twice daily for 3 months

All groups: PFMT by physiotherapist, 20‐30 minute sessions for 3 days, instructed to perform exercises twice daily for 3 months plus 3 week rehabilitation program after dischargeRegular interaction with health professional for 6 weeks after surgery, encouraged to performed treatment for 3 months post‐surgery

Yamanishi 2006

Oral PFMT plus ES for 15 minutes twice daily

Instructed pre‐operatively PFMT by nurses and continued after catheter removal

Oral PFMT plus sham device.

Instructed pre‐operatively PFMT by nurses and continued after catheter removal.

Yokoyama 2004

Intervention A: anal electrode for 15 minutes twice a day for 1 month

Intervention B: extra‐corporeal magnetic innervation, neocontrol system, treatment sessions 20 minutes, twice a week for 2 weeks

PFMT, digital anal teaching of correct contractions, then verbal and written instructions for home practice.

Zhang 2007

PFMT plus BF using rectal electrical sensor, initial 45 minute session with physical therapist then written instructions to carry out at home three times a day for 10 minutes. Plus support group, 6 meetings in 3 months with a health psychologist

PFMT plus BF using rectal electrical sensor, initial 45 minute session with physical therapist then written instructions to carry out at home three times a day for 10 minutes

Figuras y tablas -
Table 1. Details of interventions
Comparison 1. Treatment of UI after radical: PFMT ± biofeedback versus no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of incontinent men Show forest plot

9

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 less than 3 months

7

980

Risk Ratio (M‐H, Random, 95% CI)

0.95 [0.84, 1.08]

1.2 within 3‐6 months

7

895

Risk Ratio (M‐H, Random, 95% CI)

0.96 [0.83, 1.10]

1.3 within 6‐12 months

5

792

Risk Ratio (M‐H, Random, 95% CI)

0.91 [0.73, 1.14]

1.4 after 12 months

3

665

Risk Ratio (M‐H, Random, 95% CI)

0.85 [0.60, 1.22]

2 Number of incontinence episodes per day Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

2.1 less than 3 months

2

400

Mean Difference (IV, Fixed, 95% CI)

‐1.09 [‐1.39, ‐0.78]

2.2 within 3‐6 months

1

227

Mean Difference (IV, Fixed, 95% CI)

‐0.20 [‐1.40, 1.00]

2.3 within 6‐12 months

1

217

Mean Difference (IV, Fixed, 95% CI)

‐0.20 [‐1.33, 0.93]

2.4 after first year

1

211

Mean Difference (IV, Fixed, 95% CI)

0.10 [‐0.82, 1.02]

3 Number of men using pads Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3.1 less than 3 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 within 3‐6 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.3 within 6‐12 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.4 after 12 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Pad changes over 24 hours Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

4.1 less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.3 within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.4 after first year

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Urinary Incontinence Score (ICIQ‐SF) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

5.1 less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.3 within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.4 after first year

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 Quality of life related to urinary incontinence Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

6.1 less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.3 within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.4 after first year

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

7 Adverse events Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

8 24 hour pad test (grams of urine lost) Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

8.1 less than 3 months

2

214

Mean Difference (IV, Fixed, 95% CI)

22.29 [‐33.12, 77.70]

8.2 within 3‐6 months

2

213

Mean Difference (IV, Fixed, 95% CI)

11.87 [‐40.77, 64.52]

8.3 within 6‐12 months

2

194

Mean Difference (IV, Fixed, 95% CI)

11.23 [‐22.35, 44.82]

8.4 after first year

1

167

Mean Difference (IV, Fixed, 95% CI)

39.0 [‐5.72, 83.72]

9 1 hour pad test (grams of urine lost) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

9.1 less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.3 within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.4 after first year

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

10 Number of men not carrying out pelvic floor muscle contractions at 12 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Figuras y tablas -
Comparison 1. Treatment of UI after radical: PFMT ± biofeedback versus no treatment
Comparison 2. Treatment of UI after radical: electric or magnetic energy versus no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of incontinent men Show forest plot

4

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 less than 3 months

2

96

Risk Ratio (M‐H, Fixed, 95% CI)

0.77 [0.60, 0.98]

1.2 within 3‐6 months

1

53

Risk Ratio (M‐H, Fixed, 95% CI)

0.48 [0.29, 0.79]

1.3 within 6‐12 months

2

83

Risk Ratio (M‐H, Fixed, 95% CI)

0.37 [0.18, 0.73]

1.4 after 12 months

3

413

Risk Ratio (M‐H, Fixed, 95% CI)

0.26 [0.09, 0.74]

2 Adverse effects Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3 24 hour pad test (grams of urine lost) Show forest plot

2

325

Mean Difference (IV, Fixed, 95% CI)

‐16.94 [‐58.21, 24.33]

3.1 less than 3 months

2

96

Mean Difference (IV, Fixed, 95% CI)

‐27.82 [‐116.97, 61.33]

3.2 within 3‐6 months

2

93

Mean Difference (IV, Fixed, 95% CI)

5.12 [‐86.19, 96.43]

3.3 within 6‐12 months

2

89

Mean Difference (IV, Fixed, 95% CI)

‐1.95 [‐64.03, 60.13]

3.4 after first year

1

47

Mean Difference (IV, Fixed, 95% CI)

‐80.0 [‐190.50, 30.50]

4 Urinary Incontinence Score (ICIQ‐short form UI score) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

4.1 less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.3 within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.4 after first year

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Urinary Incontinence Quality of Life Score (ICIQ‐short form) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

5.1 less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.3 within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.4 after first year

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 Time until continent (months) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Figuras y tablas -
Comparison 2. Treatment of UI after radical: electric or magnetic energy versus no treatment
Comparison 4. Treatment of UI after radical: combinations of treatments versus no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of incontinent men at < 3 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 PFMT + anal Estim + Biofeedback vs no treatment

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Number of incontinent men within 3‐6 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2.1 PFMT + anal Estim + Biofeedback vs no treatment

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Number of incontinence episodes per day at > 3 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

3.1 PFMT + anal Estim + BFB

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Adverse effects Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

4.1 PFMT + anal Estim + BFB

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 4. Treatment of UI after radical: combinations of treatments versus no treatment
Comparison 5. Treatment of UI after radical: one active treatment versus another active treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of incontinent men at < 3 months Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 PFMT + Anal EStim vs PFMT alone

2

177

Risk Ratio (M‐H, Fixed, 95% CI)

0.96 [0.83, 1.12]

2 Number of incontinent men within 3 to 6 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2.1 PFMT + BF + support group vs PFMT + BF

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Number of incontinent men within 6 to 12 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3.1 FES vs ExMI

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Number of incontinence episodes at < 3 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

4.1 PFMT + anal EStim vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Quality of Life Score (severity of UI) within 3 to 6 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

5.1 PFMT + BF + support group vs PFMT + BF

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 Quality of Life Score (I‐QoL) within 6‐12 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

6.1 PFMT + BF + EStim vs PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

7 Quality of Life Score (ICI‐Q‐SF) within 6‐12 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

7.1 PFMT + ExMI vs PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

8 Adverse events Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

8.1 PFMT + Anal EStim vs PFMT alone

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9 1 hour pad test (grams of urine lost): at < 3 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

9.1 PFMT + anal EStim vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.2 PFMT + perineal EStim vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.3 PFMT + perineal EStim vs PFMT + anal EStim

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

10 24 hour pad test (grams of urine lost): at < 3 months Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

10.1 PFMT + anal EStim vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.2 PFMT + visual BF vs PFMT + oral BF

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

11 24 hour pad test (grams of urine lost): within 3 to 6 months Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

11.1 PFMT + anal EStim vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

11.2 PFMT + visual BF vs PFMT + oral BF

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

12 24 hour pad test (grams of urine lost): within 3 to 6 months Show forest plot

3

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

12.1 PFMT + anal EStim vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

12.2 PFMT + visual BF vs PFMT + oral BF

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

12.3 ExMI vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

13 Pad changes over 24 hours within 3 to 6 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

13.1 ExMI vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

14 Number of men not carrying out sufficient PFMT within 3 to 6 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

14.1 PFMT + BF + support group vs PFMT + BF

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 5. Treatment of UI after radical: one active treatment versus another active treatment
Comparison 6. Prevention of UI after radical: PFMT ± biofeedback versus no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of incontinent men Show forest plot

8

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 less than 3 months

7

663

Risk Ratio (M‐H, Random, 95% CI)

0.93 [0.83, 1.06]

1.2 within 3‐6 months

7

697

Risk Ratio (M‐H, Random, 95% CI)

0.85 [0.75, 0.97]

1.3 within 6‐12 months

6

640

Risk Ratio (M‐H, Random, 95% CI)

0.51 [0.35, 0.75]

1.4 after 12 months

2

373

Risk Ratio (M‐H, Random, 95% CI)

0.32 [0.20, 0.51]

2 Pad changes over 24 hours Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

2.1 less than 3 months

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 within 3‐6 months

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 within 6 ‐ 12 months

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 1 hour pad test (grams of urine lost) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

3.1 Less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 Within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.3 Within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 24 hour pad test (gm/24hrs) Show forest plot

4

Mean Difference (IV, Random, 95% CI)

Subtotals only

4.1 less than 3 months

3

424

Mean Difference (IV, Random, 95% CI)

‐78.19 [‐211.46, 55.07]

4.2 within 3‐6 months

2

373

Mean Difference (IV, Random, 95% CI)

‐73.28 [‐196.42, 49.86]

4.3 within 6‐12 months

2

373

Mean Difference (IV, Random, 95% CI)

‐14.50 [‐18.36, ‐10.64]

4.4 after first year

2

378

Mean Difference (IV, Random, 95% CI)

‐1.0 [‐1.81, ‐0.19]

5 Number of incontinence episodes per day Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

5.1 less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.3 within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.4 after first year

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 Urinary Incontinence Score (ICI‐short form) Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

6.1 less than 3 months

1

32

Mean Difference (IV, Random, 95% CI)

6.5 [3.45, 9.55]

6.2 within 3‐6 months

2

105

Mean Difference (IV, Random, 95% CI)

‐1.21 [‐5.99, 3.56]

6.3 within 6‐12 months

2

105

Mean Difference (IV, Random, 95% CI)

‐0.69 [‐3.19, 1.81]

7 Quality of Life Score (IIQ) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

7.1 less than 3 months

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.3 within 6‐12 months

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.4 after first year

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

8 Pelvic floor muscle strength (anal squeeze pressure, cm H2O) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

8.1 less than 3 months

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.3 within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.4 after first year

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

9 Number of men not carrying out sufficient PFMT Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

9.1 less than 3 months

0

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.2 within 3‐6 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.3 within 6‐12 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.4 after 12 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10 Number of men having surgery for incontinence Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Figuras y tablas -
Comparison 6. Prevention of UI after radical: PFMT ± biofeedback versus no treatment
Comparison 7. Prevention of UI after radical: electric or magnetic energy versus no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 1 hour pad test (grams of urine lost) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

1.1 Less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 Within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 Within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 ICIQ‐SF score Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

2.1 Less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 Within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.3 Within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 7. Prevention of UI after radical: electric or magnetic energy versus no treatment
Comparison 9. Prevention of UI after radical: combinations of treatments versus no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of incontinent men within 3 to 6 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 PFMT + anal Estim + Biofeedback versus no treatment/sham treatment

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Number of incontinent men within 6 to 12 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2.1 PFMT + anal Estim + biofeedback versus no treatment

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 24 hour pad test (grams of urine lost) within 3 to 6 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

3.1 PFMT + anal Estim + Biofeedback versus no treatment/sham treatment

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 24 hour pad test (grams of urine lost) 6 to 12 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

4.1 PFMT + anal Estim + Biofeedback versus no treatment/sham treatment

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Time until continent (months) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

5.1 PFMT + anal Estim + Biofeedback versus no treatment/sham treatment

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 9. Prevention of UI after radical: combinations of treatments versus no treatment
Comparison 10. Prevention of UI after radical: one active treatment versus another active treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of incontinent men at < 3months Show forest plot

3

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 PFMT pre and post op vs PFMT post op

2

289

Risk Ratio (M‐H, Fixed, 95% CI)

0.86 [0.69, 1.06]

1.2 PFMT + Biofeedback + transcutaneous Estim versus Estim only

1

54

Risk Ratio (M‐H, Fixed, 95% CI)

0.88 [0.61, 1.26]

1.3 PFMT + Biofeedback + transcutaneous Estim versus post‐op PFMT

1

54

Risk Ratio (M‐H, Fixed, 95% CI)

0.80 [0.57, 1.11]

1.4 Post‐op transcutaneous Estim versus post‐op PFMT

1

52

Risk Ratio (M‐H, Fixed, 95% CI)

0.90 [0.67, 1.22]

2 Number of incontinent men within 3 to 6 months Show forest plot

4

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 PFMT pre and post op vs PFMT post op

2

290

Risk Ratio (M‐H, Fixed, 95% CI)

0.75 [0.54, 1.04]

2.2 post‐op PFMT + biofeedback + transcutaneous Estim vs post‐op Estim

1

54

Risk Ratio (M‐H, Fixed, 95% CI)

1.55 [0.96, 2.49]

2.3 PFMT + general exercise versus PFMT alone

1

49

Risk Ratio (M‐H, Fixed, 95% CI)

0.48 [0.23, 0.99]

2.4 Post‐op PFMT + transcutaneous Estim + Biofeedback versus post‐op PFMT

1

54

Risk Ratio (M‐H, Fixed, 95% CI)

1.09 [0.76, 1.57]

2.5 Post‐op transcutaneous electrical stimulation versus post‐op PFMT

1

52

Risk Ratio (M‐H, Fixed, 95% CI)

0.71 [0.43, 1.16]

3 Number of incontinent men within 6 to 12 months Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3.1 PFMT pre and post op vs PFMT post op

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 post‐op PFMT + Biofeedback + transcutaneous Estim vs post‐op Estim

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.3 Post‐op PFMT + transcutaneous Estim + Biofeedback versus post‐op PFMT

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.4 Post‐op transcutaneous Estim versus post‐op PFMT

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Number of incontinent men after 12 months Show forest plot

4

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

4.1 PFMT pre and post op vs PFMT post op

3

367

Risk Ratio (M‐H, Fixed, 95% CI)

1.32 [0.78, 2.25]

4.2 PFMT + Penile vibration pre and post op versus PFMT pre and post op

1

58

Risk Ratio (M‐H, Fixed, 95% CI)

1.4 [0.25, 7.77]

5 No. with severe incontinence (e.g. pad test weight >150g) at < 3 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

5.1 PFMT pre and post op vs PFMT post op

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 No. with severe incontinence (e.g. pad test weight >150g) at 3 to 6 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

6.1 PFMT pre and post op vs PFMT post op

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7 20 minute pad test (grams of urine lost): within 3 to 6 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

7.1 PFMT + anal EStim vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.2 PFMT + anal EStim + BF vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.3 PFMT + anal EStim vs PFMT + anal EStim + BF

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

8 20 minute pad test (grams of urine lost): within 6 to 12 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

8.1 PFMT + anal EStim vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.2 PFMT + anal EStim + BF vs PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.3 PFMT + anal EStim vs PFMT + anal EStim + BF

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

9 1 hour pad test (grams of urine lost) at less than 3 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

9.1 Pre‐op PFMT + Estim versus pre‐op PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

10 1 hour pad test (grams of urine lost) within 3‐6 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

10.1 Pre‐op PFMT + electrical stimulation versus pre‐op PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

11 1 hour pad test within 6‐12 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

11.1 Pre‐op PFMT + electrical stimulation versus pre‐op PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

12 24 hour pad test (grams of urine lost) at less than 3 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

12.1 PFMT + Biofeedback + transcutaneous Estim versus Estim only

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

12.2 Post‐operative PFMT + transcutaneous Estim + Biofeedback versus post‐operative PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

12.3 Post‐operative transcutaneous electrical stimulation versus post‐operative PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

13 24 hour pad test (grams of urine lost) within 3‐6 months Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

13.1 PFMT + Biofeedback + transcutaneous Estim versus Estim only

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

13.2 Postoperative PFMT + biofeedback + transcutaneous Estim versus postoperative PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

13.3 Post‐operative transcutaneous Estim only versus post‐operative PFMT only

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

13.4 PFMT + general exercise versus PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

14 24 hour pad test (grams of urine lost) within 6‐12 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

14.1 PFMT + transcutaneous Estim + biofeedback versus Estim only

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

14.2 Post‐op PFMT + transcutaneous Estim + Biofeedback versus post‐op PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

14.3 Post‐op transcutaneous Estim versus post‐op PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

15 Quality of Life Score (ICS male short form) at < 3 months Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

15.1 PFMT pre and post op vs PFMT post op

2

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

16 Urinary Incontinence Quality of Life Score (ICIQ ‐ short form) within 3‐6 months Show forest plot

3

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

16.1 Pre‐op PFMT + electrical stimulation versus pre‐op PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

16.2 PFMT + general exercise versus PFMT alone

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

16.3 PFMT pre and post op vs PFMT post op

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

17 Urinary Incontinence Quality of Life Score (ICIQ‐short form) within 6‐12 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

17.1 Pre‐op PFMT + electrical stimulation versus pre‐op PFMT

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

18 King's health Questionnaire after 12 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

18.1 General Health

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

18.2 Role limitations

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

18.3 Physical limitations

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

18.4 Social limitations

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

18.5 Personal

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

18.6 Emotional

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

18.7 Sleep/energy disturbance

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

18.8 Symptom severity

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

19 Health status measure SF‐36 within 3‐6 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

19.1 Physical composite score

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

19.2 Mental Composite score

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

20 Adverse events Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

20.1 PFMT pre and post op vs PFMT post op

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

20.2 PFMT + Penile vibration pre and post op versus PFMT pre and post op

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 10. Prevention of UI after radical: one active treatment versus another active treatment
Comparison 11. Treatment of UI after TURP: PFMT ± biofeedback versus no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of incontinent men Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 less than 3 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 within 3‐6 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 within 6‐12 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.4 after 12 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Number of incontinence episodes per day Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

2.1 less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.3 within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.4 after first year

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Number of men using pads Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3.1 less than 3 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 within 3‐6 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.3 within 6‐12 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.4 after 12 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Urinary Incontinence Score (ICI‐short form) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

4.1 less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.3 within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.4 after first year

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Quality of life related to urinary incontinence Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

5.1 less than 3 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.2 within 3‐6 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.3 within 6‐12 months

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.4 after first year

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 Number of men not carrying out pelvic floor muscle contractions at 12 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Figuras y tablas -
Comparison 11. Treatment of UI after TURP: PFMT ± biofeedback versus no treatment
Comparison 16. Prevention of UI after TURP:  pre or post‐operative PFMT ± biofeedback versus no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of incontinent men Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 less than 3 months

2

105

Risk Ratio (M‐H, Fixed, 95% CI)

0.60 [0.21, 1.77]

1.2 within 3‐6 months

1

48

Risk Ratio (M‐H, Fixed, 95% CI)

0.51 [0.14, 1.89]

2 Health status measure SF‐36 within 3‐6 months Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

2.1 Physical component

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 Physical functioning

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.3 Body pain

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.4 General Health

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.5 Physical role limitation

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.6 Mental health component

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.7 Mental role limitation

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.8 Vitality

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.9 Mental health

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.10 Social functioning

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 16. Prevention of UI after TURP:  pre or post‐operative PFMT ± biofeedback versus no treatment
Comparison 21. Containment of urinary incontinence from any cause: external penile compression devices (penile clamps) versus no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of men satisfied with device Show forest plot

Other data

No numeric data

2 Mean urine loss (grams of urine on pad test) Show forest plot

Other data

No numeric data

3 Penile Doppler blood flow (mean systolic velocity) Show forest plot

Other data

No numeric data

4 Penile Doppler blood flow (mean resistence to flow index) Show forest plot

Other data

No numeric data

Figuras y tablas -
Comparison 21. Containment of urinary incontinence from any cause: external penile compression devices (penile clamps) versus no treatment