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Cirugía para mujeres con prolapso del compartimiento anterior

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Referencias

References to studies included in this review

Ali 2006 abstract {published data only}

Ali S, Han HC, Lee LC. A prospective randomized trial using Gynemesh PS (trademark) for the repair of anterior vaginal wall prolapse (Abstract number 292). International Urogynecology Journal 2006;17 Suppl 2:221. CENTRAL

Allahdin 2008 {published data only}

Allahdin S, Glazener C, Bain C. A randomised controlled trial evaluating the use of polyglactin mesh, polydioxanone and polyglactin sutures for pelvic organ prolapse surgery. Journal of Obstetrics and Gynaecology 2008;28(4):427‐31. CENTRAL
Madhuvrata P, Glazener C, Boachie C, Allahdin S, Bain C. A randomised controlled trial evaluating the use of polyglactin (Vicryl) mesh, polydioxanone (PDS) or polyglactin (Vicryl) sutures for pelvic organ prolapse surgery: outcomes at 2 years. Journal of Obstetrics and Gynaecology 2011;31(5):429‐35. CENTRAL

Altman 2011 {published data only}

Altman D, Väyrynen T, Engh ME, Axelsen S, Falconer C, for the Nordic Transvaginal Mesh Group. Anterior colporrhaphy versus transvaginal mesh for pelvic‐organ prolapse. New England Journal of Medicine 2011;364(19):1826‐36. [41463]CENTRAL
Ek M, Altman D, Elmér C, Gunnarsson J, Falconer C, Tegerstedt G. Clinical efficacy of a trocar guided mesh kit for the repair of anterior lateral defects (Abstract number 556). Proceedings of the 41st Annual Meeting of the International Continence Society (ICS), 2011 Aug 29 to Sept 2, Glasgow, Scotland. 2011. CENTRAL
Ek M, Tegerstedt G, Falconer C, Kjaeldgaard A, Rezapour M, Rudnicki M, et al. Urodynamic assessment of anterior vaginal wall surgery: a randomized comparison between colporrhaphy and transvaginal mesh. Neurourology and Urodynamics 2010;29:527‐31. [39589]CENTRAL

Carey 2009 {published data only}

Carey M, Higgs P, Goh J, Lim J, Leong A, Krause H, et al. Vaginal repair with mesh versus colporrhaphy for prolapse: a randomised controlled trial. BJOG 2009;116(10):1380‐6. [32066]CENTRAL

Colombo 2000 {published data only}

Colombo M, Vitobello D, Proietti F, Milani R. Randomised comparison of Burch colposuspension versus anterior colporrhaphy in women with stress urinary incontinence and anterior vaginal wall prolapse. BJOG 2000;107(4):544‐51. CENTRAL

Dahlgren 2011 {published data only}

Dahlgren E, Kjolhede P, on behalf of the RPOP‐PELVICOL Study Group∗. Long‐term outcome of porcine skin graft in surgical treatment of recurrent pelvic organ prolapse. An open randomized controlled multicenter study. Acta Obstetricia et Gynecologica Scandinavica 2011;90:1393‐401. CENTRAL

Delroy 2013 {published data only}

Delroy CA, Castro Rde A, Dias MM, Feldner PC, Bortolini MA, Girao MS. The use of transvaginal synthetic mesh for anterior vaginal wall prolapse repair: a randomized controlled trial. International Urogynecology Journal 2013;24(11):1899‐907. CENTRAL

De Ridder 2004 abstract {published data only}

De Ridder D, Claehout F, Verleyen P, Boulanger S, Deprest J. Porcine dermis xenograft as reinforcement for cystocele stage III repair: a prospective randomized controlled trial (Abstract). Neurourology and Urodynamics 2004;23:435‐6. CENTRAL

De Tayrac 2013 {published data only}

de Tayrac R, Cornille A, Eglin G, Guilbaud O, Mansoor A, Alonso A, et al. Comparison between trans‐obturator trans‐vaginal mesh and traditional anterior colporrhaphy in the treatment of anterior vaginal wall prolapse: results of a French RCT. International Urogynecology Journal 2013;24:1651‐61. CENTRAL

El‐Nazer 2007 {published data only}

Al‐Nazer MA, Ismail WA, Gomaa IA. Comparative study between anterior colporrhaphy versus vaginal wall repair with mesh for management of anterior vaginal wall prolapse (Abstract number 84). International Urogynecology Journal 2007;18 Suppl 1:49‐50. CENTRAL
El‐Nazer M, Gomaa I, Ismail Madkour W, Swidan K, El‐Etriby M. Anterior colporrhaphy versus repair with mesh for anterior vaginal wall prolapse: a comparative clinical study. Archives of Gynecology and Obstetrics 2012;286:965‐72. CENTRAL

Farthmann 2012 {published data only}

Farthmann J, Niesel A, Fuenfgeld C, Kraus A, Lenz F, Augenstein H, et al. PARETO trial: three‐year follow‐up of a prospective randomized study on mesh exposure rates, recurrences and quality of life after mesh implantation for pelvic organ prolapse. International Urogynecology Journal 2013;24(083):S63. CENTRAL

Feldner 2010 {published data only}

Feldner PC, Castro RA, Cipolotti LA, Delroy CA, Sartori MG, Girao MJ. Anterior vaginal wall prolapse: a randomized controlled trial of SIS graft versus traditional colporrhaphy. International Urogynecology Journal 2010;21(9):1057‐63. [40053]CENTRAL
Feldner PC, Castro RA, Delroy CA, Dias MM, Sartori MG, Girao MJ. Surgical treatment of anterior vaginal wall prolapse: comparison of small intestine submucosa (SIS) graft and traditional repair (Abstract number 160). International Urogynecology Journal 2009;20 Suppl 2:S208‐9. [39890]CENTRAL

Gandhi 2005 {published data only}

Gandhi S, Goldberg RP, Kwon C, Koduri S, Beaumont JL, Abramov Y, et al. A prospective randomized trial using solvent dehydrated fascia lata for the prevention of recurrent anterior vaginal wall prolapse. American Journal of Obstetrics and Gynecology 2005;192:1649‐54. CENTRAL
Gandhi S, Kwon C, Goldberg RP, Abramov Y, Beaumont JL, Koduri S, et al. A randomized controlled trial of fascia lata for the prevention of recurrent anterior vaginal wall prolapse. Neurourology and Urodynamics 2004;23(5/6):558. CENTRAL
Kwon C, Goldberg R, Evaston IL, Koduri S, Franklin WI, Gandhi S, et al. Preliminary results of a prospective randomized trial of tutoplast processed fascia lata to prevent recurrent cystoceles and rectoceles. Journal of Urology 2002;167:203. CENTRAL

Guerette 2009 {published data only}

Guerette NL, Aguirre O, VanDrie DM, Biller DH, Davila GW. Multi‐center, randomized, prospective trial comparing anterior colporrhaphy alone to bovine pericardium collagen matrix graft reinforced anterior colporrhaphy: 12‐month analysis (Abstract number 11). International Urogynecology Journal 2006;17 Suppl 2:63‐4. CENTRAL
Guerette NL, Peterson TV, Aguirre OA, VanDrie DM, Biller DH, Davila GW. Anterior repair with or without collagen. Obstetrics & Gynecology 2009;114:59‐65. CENTRAL

Gupta 2014 {published data only}

Gupta B, Vaid NB, Suneja A, Guleria K, Jain S. Anterior vaginal prolapse repair: a randomised trial of traditional anterior colporrhaphy and self‐tailored mesh repair. South African Journal of Obstetrics and Gynaecology 2014;20(2):47‐50. CENTRAL

Hviid 2010 {published data only}

Hviid U, Hviid TV, Rudnicki M. Porcine skin collagen implants for anterior vaginal wall prolapse: a randomised prospective controlled study. International Urogynecology Journal 2010;21(5):529‐34. [39449]CENTRAL

Lamblin 2014 {published data only}

Lamblin G, Van‐Nieuwenhuyse A, Chabert P, Lebail‐Carval K, Moret S, Mellier G. A randomized controlled trial comparing anatomical and functional outcome between vaginal colposuspension and transvaginal mesh. International Urogynecology Journal 2014;25:961–70. [DOI: 10.1007/s00192‐014‐2344‐7]CENTRAL

Menefee 2011 {published data only}

Dyer K, Nguyen J, Lukacz E, Simsiman A, Luber K, Menefee S. The Optimal Anterior Repair Study (OARS): a triple arm randomized double blinded clinical trial of standard colporrhaphy, porcine dermis or polypropylene mesh augmented anterior vaginal wall repair (Abstract number 252). Neurourology and Urodynamics 2009;28(7):894‐5. [39346]CENTRAL
Dyer K, Nguyen J, Simsiman A, Lukacz E, Luber K, Menefee S. The Optimal Anterior Repair Study (OARS): a triple arm randomized double blinded clinical trial of standard colporrhaphy versus vaginal paravaginal repair with porcine dermis graft or polypropylene mesh (Abstract number 281). Neurourology and Urodynamics 2010;29(6):1207‐8. [40164]CENTRAL
Menefee SA, Dyer KY, Lukacz ES, Simsiman AJ, Luber KM, Nguyen JN. Colporrhaphy compared with mesh or graft‐reinforced vaginal paravaginal repair for anterior vaginal wall prolapse: a randomized controlled trial. Obstetrics and Gynecology 2011;118(6):1337‐44. [42866]CENTRAL

Meschia 2007 {published and unpublished data}

Kocjancic E, Crivellaro S, Bernasconi F, Magatti F, Frea B, Meschia M. A two years follow‐up, prospective randomized study on cystocele repair with or without Pelvicol (trademark) implant (Abstract number 1374). Proceedings of the Annual Meeting of the American Urological Association, 19‐24 May 2007, Anaheim (CA). 2007. CENTRAL
Meschia M, Pifarotti P, Bernasconi F, Magatti F, Riva D, Kojancic E. Porcine skin collagen implants to prevent anterior vaginal wall prolapse recurrence: a multicentre, randomized study. Journal of Urology 2007;177:192‐5. CENTRAL
Meschia M, Pifarotti P, Magatti F, Bernasconi F, Riva D, Kojancic E. Porcine skin collagen implants (Pelvicol) (trademark) to prevent anterior vaginal wall prolapse recurrence: a randomized study (Abstract). Neurourology and Urodynamics 2005;24(5/6):587‐8. CENTRAL

Minassian 2010 abstract {published data only}

Minassian V, Parekh M, Poplawsky D, Litzy L. Randomized controlled trial comparing anterior colporrhaphy to abdominal paravaginal defect repair for anterior vaginal wall prolapse (Abstract number 54). Neurourology and Urodynamics 2010;29(6):885‐6. [40126]CENTRAL
Minassian VA, Parekh M, Poplawsky D, Gorman J, Litzy L. Randomized controlled trial comparing two procedures for anterior vaginal wall prolapse. Neurourology and Urodynamics 2014;33:72‐7. CENTRAL

Natale 2009 {published data only}

Cervigni M, Natale F, Weir J, Galante L, Panei M, Agostini M, et al. Prospective randomized trial of two new materials for the correction of anterior compartment prolapse: Pelvicol and Prolene Soft (Abstract). Neurourology and Urodynamics 2005;24(5/6):585‐6. CENTRAL
Natale F, La Penna C, Padoa A, Agostini M, De Simone E, Cervigni M. A prospective, randomized, controlled study comparing Gynemesh(R), a synthetic mesh, and Pelvicol(R), a biologic graft, in the surgical treatment of recurrent cystocele. International Urogynecology Journal 2009;20(1):75‐81. CENTRAL

Nguyen 2008 {published and unpublished data}

Nguyen JN, Burchette RJ. Anatomy and visceral function after anterior vaginal prolapse repair: a randomized controlled trial (Abstract number 42). Proceedings of the 29th Annual Meeting of the American Urogynecologic Society (AUGS), Sept 4‐6, Chicago. 2008. CENTRAL
Nguyen JN, Burchette RJ. Outcome after anterior vaginal prolapse repair. Randomized controlled trial. Obstetrics and Gynecology 2008;111(4):891‐8. CENTRAL

Nieminen 2008 {published data only}

Hiltunen R, Nieminen K, Takala T, Heiskanen E, Merikari M, Niemi K, et al. Low‐weight polypropylene mesh for anterior vaginal wall prolapse: a randomized controlled trial. Obstetrics and Gynecology 2007;110(2 Pt 2):455‐62. CENTRAL
Nieminen K, Hiltunen R, Heiskanen E, Takala T, Niemi K, Merikari M, et al. Symptom resolution and sexual function after anterior vaginal wall repair with or without polypropylene mesh. International Urogynecology Journal 2008;19(12):1611‐6. CENTRAL
Nieminen K, Hiltunen R, Takala T, Heiskanen E, Merikari M, Niemi K, et al. Outcomes after anterior vaginal wall repair with mesh: a randomized, controlled trial with a 3 year follow‐up. American Journal of Obstetrics and Gynecology 2010;203(3):235.e1‐8. [40020]CENTRAL

Robert 2014 {published data only}

Robert M, Girard I, Brennand E, Tang S, Birch C, Murphy M, et al. Absorbable mesh augmentation compared with no mesh for anterior prolapse: a randomised controlled trial. Obstetrics and Gynecology 2014;123(2 Part 1):288‐94. CENTRAL

Rudnicki 2014 {published data only}

Rudnicki M, Laurikainen E, Pogosean R, Kinne I, Jakobsson U, Teleman P. Anterior colporrhaphy compared with collagen‐coated transvaginal mesh for anterior vaginal wall prolapse: a randomised controlled trial. BJOG 2014;121:102‐11. CENTRAL

Sand 2001 {published data only}

Goldberg RP, Koduri S, Lobel RW, Culligan PJ, Tomezsko JE, Winkler HA, et al. Long‐term effects of three different anti‐incontinence procedures on the posterior compartment (Abstract). Proceedings of the International Continence Society (ICS) 31st Annual Meeting; 2001 Sept 18‐21; Seoul, Korea. 2001. CENTRAL
Sand PK, Koduri S, Lobel RW, Winkler HA, Tomezsko J, Culligan PJ, et al. Prospective randomized trial of polyglactin 910 mesh to prevent recurrence of cystoceles and rectoceles. American Journal of Obstetrics and Gynecology 2001;184(7):1357‐64. CENTRAL

Sivaslioglu 2008 {published data only}

Sivaslioglu AA, Unlubilgin E, Dolen I. A randomized comparison of polypropylene mesh surgery with site‐specific surgery in the treatment of cystocoele. International Urogynecology Journal 2008;19(4):467‐71. CENTRAL

Tamanini 2015 {published data only}

Tamanini JT, de Oliveira Souza Castro RC, Tamanini JM, Castro RA, Sartori MG, Girão MJ. A prospective, randomized, controlled trial for the treatment of anterior vaginal wall prolapse: medium term followup. Journal of Urology 2015;193(4):1298‐304. CENTRAL
Tamanini JT, de Oliveira Souza Castro RC, Tamanini JM, Castro RA, Sartori MG, João M. Treatment of anterior vaginal wall prolapse with and without polypropylene mesh: a prospective, randomized and controlled trial ‐ Part I. International Brazilian Journal of Urology 2013;39(4):519‐30. CENTRAL

Thijs 2010 abstract {published data only}

Thijs S, Deprest J, De Ridder D, Claerhout F, Roovers J. A randomized controlled trial of anterior colporrhaphy and Perigee™ as a primary surgical correction of symptomatic cystocele (Abstract number 96). International Urogynecology Journal 2010;21 Suppl 1:S142‐3. [40133]CENTRAL

Turgal 2013 {published data only}

Turgal M, Sivaslioglu A, Yildiz A, Dolen I. Anatomical and functional assessment of anterior colporrhaphy versus polypropylene mesh surgery in cystocele treatment. European Journal of Obstetrics and Gynecology and Reproductive Biology 2013;170(2):555‐8. CENTRAL

Vollebregt 2011 {published data only}

Vollebregt A, Fischer K, Gietelink D, van der Vaart CH. Primary surgical repair of anterior vaginal prolapse: a randomised trial comparing anatomical and functional outcome between anterior colporrhaphy and trocar‐guided transobturator anterior mesh. BJOG 2011;118(12):1518‐27. [42606]CENTRAL
Vollebregt A, Gietelink D, Fischer K, van der Vaart H. One year results of colporrhaphy anterior versus a trocar guided transobturator synthetic mesh in primary cystocele repair: a randomized controlled trial (Abstract number 51). Neurourology and Urodynamics 2010;29(6):880‐2. [40124]CENTRAL

Weber 2001 {published data only}

Weber AM, Walters MD, Piedmonte MR, Ballard LA. Anterior colporrhaphy: a randomized trial of three surgical techniques. American Journal of Obstetrics and Gynecology 2001;185(6 Pt 1):1299‐306. CENTRAL

Withagen 2011 {published and unpublished data}

Milani AL, Withagen MI, The HS, Nedelcu‐Van der Wijk I, Vierhout ME. Sexual function following trocar‐guided mesh or vaginal native tissue repair in recurrent prolapse: a randomized controlled trial. Journal of Sexual Medicine 2011;8(10):2944‐53. [42064]CENTRAL
Withagen MI, Milani AL, Boon Den J, Vervest HA, Vierhout ME. Tension free vaginal mesh compared to conventional vaginal prolapse surgery in recurrent prolapse: a randomized controlled trial (Abstract number 090). International Urogynecology Journal 2009;20 Suppl 2:S153‐4. [39885]CENTRAL
Withagen MI, Milani AL, den Boon J, Vervest HA, Vierhout ME. Trocar‐guided mesh compared with conventional vaginal repair in recurrent prolapse: a randomized controlled trial. Obstetrics and Gynecology 2011;117(2 Pt 1):242‐50. [40881]CENTRAL

References to studies excluded from this review

Heinonen 2011 {published data only}

Heinonen PK, Nieminen K. Combined anterior vaginal wall mesh with sacrospinous ligament fixation or with posterior intravaginal slingplasty for uterovaginal or vaginal vault prolapse. European Journal of Obstetrics, Gynecology, and Reproductive Biology 2011;157(2):230‐3. CENTRAL

Kringel 2010 {published data only}

Kringel U, Reimer T, Tomczak S, Green S, Kundt G, Gerber B. Postoperative infections due to bladder catheters after anterior colporrhaphy: a prospective, randomized three‐arm study. International Urogynecology Journal 2010;21(12):1499‐504. CENTRAL

Tincello 2009 {published data only}

Tincello DG, Kenyon S, Slack M, Toozs‐Hobson P, Mayne C, Jones D, et al. Colposuspension or TVT with anterior repair for urinary incontinence and prolapse: results of and lessons from a pilot randomised patient‐preference study (CARPET 1). BJOG 2009;116(13):1809‐14. CENTRAL
Tincello DG, Mayne CJ, Toozs‐Hobson P, Slack M. Randomised controlled trial of colposuspension versus anterior repair plus TVT for urodynamic stress incontinence with anterior vaginal prolapse: proposal (Abstract). Proceedings of the International Continence Society, 11th Annual Scientific Meeting; 2004 Mar 18‐19; Bournemouth, United Kingdom. 2004:46. [17170]CENTRAL

Van Der Steen 2011 {published data only}

Van Der Steen A, Detollenaere R, Den Boon J, Van Eijndhoven H. One‐day versus 3‐day suprapubic catheterization after vaginal prolapse surgery: a prospective randomized trial. International Urogynecology Journal 2011;22(5):563‐7. CENTRAL

Weemhoff 2011 {published data only}

Weemhoff M, Wassen MM, Korsten L, Serroyen J, Kampschöer PH, Roumen FJ. Postoperative catheterization after anterior colporrhaphy: 2 versus 5 days. A multicentre randomized controlled trial. International Urogynecology Journal 2011;22(4):477‐83. CENTRAL

ACTRN12616000159459 {unpublished data only}

ACTRN12616000159459. Anterior Pelvic Organ Prolapse Surgery: A randomised controlled trial of Xenform anterior repair versus anterior colporrhaphy [Anterior Pelvic Organ Prolapse Surgery: A randomised controlled trial of Xenform anterior repair versus anterior colporrhaphy evaluating at one‐year: recurrence, quality of life and need for re‐operation on anterior pelvic organ prolapse]. http://www.anzctr.org.au/ACTRN12616000159459.aspx 13 November 2015. CENTRAL

Cortesse 2010 {published data only}

Cortesse A. Evaluating the necessity of TOT implantation in women with pelvic organ prolapse and occult stress urinary incontinence (ATHENA). http://clinicaltrials.gov/ct2/show/NCT01095692 (accessed 19 April 2011)2011. [41350]CENTRAL

Glazener 2009 {published data only}

Glazener CMA. Clinical and cost‐effectiveness of surgical options for the management of anterior and/or posterior vaginal wall prolapse: two randomised controlled trials within a comprehensive cohort study (PROSPECT). www.controlled‐trials.com/ISRCTN60695184 (accessed 13 April 2010)2009. CENTRAL

Lucot 2015 {published data only}

Lucot JP, Cosson M, Debodinance P, Bader G, Youssef A, Akladios C, et al. PROSPERE randomized controlled trial: Laparoscopic sacropexy versus vaginal mesh for cystocele pop repair. International Urogynecology Journal and Pelvic Floor Dysfunction 2015;26(1 Suppl 1):Abstract number PP 03. CENTRAL

NCT00955448 {published data only}

NCT00955448. Randomized Controlled Trial of SIS Mesh for Anterior Repair: A Pilot Study [Trial of Small Intestine Submucosa (SIS) Mesh for Anterior Repair: A Pilot Study (Anterior SIS)]. http://clinicaltrials.gov/show/NCT00955448 5 August 2009. CENTRAL

NCT01497171 {published data only}

NCT01497171. The Elegant Trial: Elevate Transvaginal Mesh Versus Anterior Colporrhaphy [Safety and Efficacy of Transvaginal Mesh Colposuspension for Anterior Vaginal Prolapse: the Elevate vs. Anterior Colporrhaphy Trial]. http://clinicaltrials.gov/show/NCT01497171 20 December 2011. CENTRAL

Verleyen 2004 {published data only}

Verleyen P, Filip C, Bart K, Frank VDA, Jan D, Dirk DR. A prospective randomised trial comparing Pelvicol (trademark) and Vicryl (trademark) for cystocoele repair in the Raz‐colposuspension (Abstract number 613). Proceedings of the International Continence Society (34th Annual Meeting) and the International Urogynecological Association; 2004 Aug 23‐27; Paris. 2004. CENTRAL

Adams 2004

Adams E, Thomson A, Maher C, Hagen S. Mechanical devices for pelvic organ prolapse in women. Cochrane Database of Systematic Reviews 2004, Issue 2. [DOI: 10.1002/14651858.CD004010.pub2]

Atkins 2004

Atkins D, Best D, Briss PA, Eccles M, Falck‐Ytter Y, Flottorp S, et al. GRADE Working Group. Grading quality of evidence and strength of recommendations. BMJ 2004;328(7454):1490.

Brubaker 2002

Brubaker L, Bump R, Jacquetin B, Schuessler B, Weidner A, Zimmern P, et al. Pelvic organ prolapse. Incontinence: 2nd International Consultation on Incontinence. 2nd Edition. Plymouth: Health Publication Ltd, 2002:243‐65.

Bump 1998

Bump R, Norton P. Epidemiology and natural history of pelvic floor dysfunction. Obstetrics and Gynecology Clinics of North America 1998;25(4):723‐46. [MEDLINE: 99120121]

Carey 2001

Carey MP, Dwyer PL. Genital prolapse: vaginal versus abdominal route of repair. Current Opinion in Obstetrics and Gynecology 2001;13(5):499‐505. [MEDLINE: 21430847]

Ek 2010

Ek M, Tegerstedt G, Falconer C, Kjaeldgaard A, Rezapour M, Rudnicki M, et al. Urodynamic assessment of anterior vaginal wall surgery: a randomized comparison between colporrhaphy and transvaginal mesh. Neurourology and Urodynamics 2010;29:527‐31. [39589]

Ek 2011

Ek M, Altman D, Elmér C, Gunnarsson J, Falconer C, Tegerstedt G. Clinical efficacy of a trocar guided mesh kit for the repair of anterior lateral defects (Abstract number 556). Proceedings of the 41st Annual Meeting of the International Continence Society (ICS), 2011 Aug 29 to Sept 2, Glasgow, Scotland. 2011.

Fatton 2007

Fatton B, Amblard J, Debodinance P, Cosson M, Jacqutin B. Transvaginal repair of genital prolapse: preliminary results of anew tension‐free vaginal mesh (Prolift technique) ‐ a case series multicentric study. International Urogynecology Journal and Pelvic Floor Dysfunction 2007;18:743–52.

FDA 2011

Food, Drug Administration (FDA). Surgical mesh for POP and SUI repair: FDA executive summary. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/UCM270402.pdf. Published 23 August 2011 Accessed 19th September 2015.

Ford 2015

Ford AA, Rogerson L, Cody JD, Ogah J. Mid‐urethral sling operations for stress urinary incontinence in women. Cochrane Database of Systematic Reviews 2015, Issue 7. [DOI: 10.1002/14651858.CD006375.pub3]

Gill 1998

Gill EJ, Hurt WG. Pathophysiology of pelvic organ prolapse. Obstetrics and Gynecology Clinics of North America 1998;25(4):759‐69. [MEDLINE: 99120123]

GRADEpro GDT 2014 [Computer program]

McMaster University. GRADEpro GDT 2014. Version Hamilton (ON) GRADE Working Group. McMaster University, 2014 [Version accessed prior to November 2016].

Hagen 2011

Hagen S, Stark D. Conservative prevention and management of pelvic organ prolapse in women. Cochrane Database of Systematic Reviews 2011, Issue 12. [DOI: 10.1002/14651858.CD003882.pub4]

Handa 2004

Handa VL, Garrett E, Hendrix S, Gold E, Robbins J. Progression and remission of pelvic organ prolapse: a longitudinal study of menopausal women. American Journal of Obstetrics and Gynecology 2004;190(1):27‐32.

Hendrix 2002

Hendrix SL, Clark A, Nygaard I, Aragaki A, Barnabei V, McTiernan A. Pelvic organ prolapse in the Women's Health Initiative: gravity and gravidity. American Journal of Obstetrics and Gynecology 2002;186(6):1160‐6.

Higgins 2003

Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta‐analyses. BMJ 2003;327:557‐60.

Higgins 2011

Higgins JP, Green S, editor(s). The Cochrane Collaboration. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. handbook.cochrane.org. [Other: www.cochrane‐handbook.org.]2011.

MacLennan 2000

MacLennan AH, Taylor AW, Wilson DH, Wilson D. The prevalence of pelvic floor disorders and their relationship to gender, age, parity and mode of delivery. British Journal Obstetrics and Gynaecology 2000;107(12):1460‐70. [MEDLINE: 21029149]

Maher 2016

Maher C, Feiner B, Baessler K, Christmann‐Schmid C, Haya N, Marjoribanks J. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cochrane Database of Systematic Reviews 2016, Issue 2. [DOI: 10.1002/14651858.CD012079]

MHRA 2014

Medicines and Healthcare Products Regulatory Agency (MHRA). A summary of the evidence on the benefits and risks of vaginal mesh implants. https://www.gov.uk/government/publications/vaginal‐mesh‐implants‐summary‐of‐benefits‐and‐risks.October 2014.

Moher 2009

Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta‐analyses: the PRISMA statement. BMJ 2009;339:2535.

Olsen 1997

Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstetrics and Gynecology 1997;89(4):501‐6.

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The Cochrane Collaboration. Review Manager 5 (RevMan 5) Version 5.3. Copenhagen: Nordic Cochrane Centre: The Cochrane Collaboration, 2014.

References to other published versions of this review

Maher 2004

Maher C, Baessler K, Glazener CMA, Adams EJ, Hagen S. Surgical management of pelvic organ prolapse in women. Cochrane Database of Systematic Reviews 2004, Issue 4. [DOI: 10.1002/14651858.CD004014.pub2]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ali 2006 abstract

Methods

Single‐centre RCT

Inclusion grade 3 or 4 cysto‐urethrocele (BW halfway system)

No exclusion

No power

Randomisation and concealment, blinding NS

6/12 follow‐up

Participants

No CONSORT

N = 108

Inclusion: women with grade 3 or 4 cysto‐urethrocele (BW halfway system)

No significant differences between groups regarding preoperative storage symptoms, urodynamics and degree of prolapse

Interventions

A (54): anterior colporrhaphy alone

B (54): anterior colporrhaphy with tension‐free polypropylene (Gynemesh PS) overlay

Outcomes

Assessed at 6 months postop

Reported the following review outcomes

  1. Recurrent prolapse (anterior compartment) at 6 months

  2. Objective failure of anterior compartment at 6 months (grade 2 or worse anterior wall prolapse)

  3. Mesh erosion

Notes

 

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not stated

Allocation concealment (selection bias)

Unclear risk

Not stated

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not stated

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not stated

Incomplete outcome data (attrition bias)
All outcomes

High risk

Significant attrition: group AC: 46/54: mesh 43/54 completed 6/12‐month review

Selective reporting (reporting bias)

Low risk

Main outcomes reported

Other bias

Unclear risk

Not stated

Allahdin 2008

Methods

Single‐centre RCT comparing vaginal fascial repair with or without polyglactin mesh and with polydioxanone or polyglactin sutures; 2 × 2 factorial design

PC randomisation, "secure" remote concealment

Blinded participants, ward staff and follow‐up assessor

Follow‐up at 3 months with exam, at 6 months with non‐validated questionnaire, at 2 years with validated questionnaire

Participants

73 randomised, 7 ineligible after randomisation, 66 included in trial

Lost to follow‐up: 8 at 3 months, 4 at 6 months, 12 at 2 years

Inclusion: grade 2 or greater prolapse (unclear examination technique), anterior and/or posterior prolapse

Concomitant procedures: vaginal hysterectomy 14, cervical amputation (Manchester) 18, TVT 13

Interventions

A (32): repair with polyglactin mesh overlay

B (34): repair without mesh

C (33): repair of fascia with polydioxanone sutures

D (33): repair of fascia with polyglactin sutures

Outcomes

Assessed at 3 months, 6 months and 2 years postop

Reported the following review outcomes

  1. Awareness of prolapse (residual feeling of something coming down) at 2 years

  2. Repeat prolapse surgery at 2 years

  3. Recurrent prolapse on objective examination at 3 months

  4. Death (any cause) by 2 years

  5. Objective failure rate stage 2 POPQ at Aa, Ba, Ap or B

  6. Bladder function: urinary incontinence at 2 years

  7. Bowel function: faecal incontinence (no comparative data)

  8. Sexual function: dyspareunia at 2 years (not de novo)

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated

Allocation concealment (selection bias)

Low risk

Secure method of concealment of randomisation (remote computer allocation)

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Allocation concealed from women

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Reviewers blinded; participant‐completed questionnaires; data entry blinded to randomisation

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Equal non‐response between groups, medical records seen for all non‐responders: 1 year ‐ Vicryl mesh 29/32, no mesh 32/34, PDS 29/33, Vicryl suture 33/33

Selective reporting (reporting bias)

Low risk

Main outcomes reported

Other bias

Low risk

Unfunded study

Altman 2011

Methods

Multi‐centre RCT: 53 centres, 58 surgeons

90% powered to detect 20% differences between groups with 1% type 1 error, central randomisation PC

Participants blinded

Reviews conducted for 2 and 12 months by surgeon 1/3, non‐surgeon 2/3

Completed before and at 1 year: Urogenital Distress Inventory (UDI) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ‐12)

Participants

1685 screened, 389 randomised

Underwent surgery: A 182, B 191

Lost to follow‐up: A 7, B 14 (1 year: A 182, B 186)

Inclusion: > 18 years, ≥ stage 2  symptomatic cystocele POPQ

Exclusion: previous cancer of any pelvic organ, systemic glucocorticoid treatment, insulin‐treated diabetes, inability to participate or provide consent, need for concomitant surgery

Interventions

A (182): anterior colporrhaphy, slow absorption monofilament thread, sham skin markings, excessive trimming of vagina discouraged

B (191): Gynecare transvaginal anterior mesh (Prolift), absorbable sutures, excessive vaginal trimming discouraged, catheter care at discretion of surgeon

 

Outcomes

Assessed at 1 year postop

Reported the following review outcomes at 1 year

  1. Awareness of prolapse (woman‐reported vaginal bulge)

  2. Repeat prolapse surgery

  3. Mesh exposure (obtained by personal communication)

  4. Repeat continence surgery

  5. Objective failure of anterior compartment ≥ stage 2

  6. Bladder injury (perforation)

  7. Bladder function: new SUI

Sexual function: dyspareunia, PISQ (end scores with 95% CI)

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated randomisation

Allocation concealment (selection bias)

Low risk

Secure concealment with remote computer

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Participants blinded (sham skin markings)

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Reviewers: surgeon 1/3, non‐surgeon 2/3

Participant‐completed questionnaires

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Participant flow accounted for completely in both groups: at 1 year ‐ 186/206 AC, 182/204 mesh

Selective reporting (reporting bias)

Low risk

Main outcomes reported with exception of mesh exposure (personal communication)

Other bias

High risk

Funded by Karolinska Institute and Ethicon: Conflict of interest statements from members of Nordic transvaginal mesh group who were reviewers of surgery were not provided

Carey 2009

Methods

Single‐centre RCT

CONSORT: no

Randomisation computer generated

Allocation concealment NS

Participants, surgeons and reviewers not blinded

12‐Month follow‐up

Participants

Inclusion criteria: women recommended for vaginal surgery for anterior and posterior compartment with ≥ grade 2 prolapse

Exclusion criteria: requiring only anterior or posterior compartment surgery with apical prolapse beyond the hymen, those requiring abdominal mesh surgery

Randomised: 139 (A 70, B 69); 10 women breached study protocol and 11 more were recruited. All were analysed.

Lost to follow‐up: A 6, B 9

Analysed at 12 months: A 63, B 61

Interventions

A (70): traditional anterior and posterior fascial plication with polydioxanone sutures

B (69): anterior and posterior repair with Gynemesh PS augmentation

Outcomes

Assessed at 6 months and 1 year postop

Reported the following review outcomes at 1 year

  1. Awareness of prolapse

  2. Recurrent prolapse

  3. Mesh erosion

  4. Objective failure of anterior compartment

  5. Sexual function: new dyspareunia

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated

Allocation concealment (selection bias)

High risk

No information on allocation concealment. Significant preoperative data missing, as above

Blinding of participants and personnel (performance bias)
All outcomes

High risk

No blinding

Blinding of outcome assessment (detection bias)
All outcomes

High risk

No blinding

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Clear follow‐up of participants in both groups: 1 year ‐ no mesh 62/78 (89%), mesh 61/69 (88%)

Selective reporting (reporting bias)

Low risk

Main outcomes reported

Other bias

High risk

Colombo 2000

Methods

Single‐centre RCT (computer‐generated open number list )
Burch or anterior repair for pelvic organ prolapse and stress urinary incontinence
PC open list
Follow‐up: A 14.2, B 13.9 years

Participants

71 randomised
Lost to follow‐up: 3 (A 2, B 1)
68 analysed
Inclusion: USI, cystocele > 2 or 3, swab test > 30%
Exclusion: detrusor overactivity, previous pelvic floor surgery, high risk for abdominal operation

Interventions

A (35): Burch group: total abdominal hysterectomy and vault to uterosacral ligament, Moschcowitz, Burch with 3‐4 Ethibond
B (33): anterior colporrhaphy: vaginal hysterectomy, pouch of Douglas obliteration, anchoring of vaginal cuff to uterosacral ligament, catgut plication

Outcomes

Definition of cure: no subjective stress urinary incontinence, no positive stress test
Objective cure ‐ cystocele: A 23/35, B 32/33
Subjective cure ‐ stress urinary incontinence: A 30/35, B 17/32
Objective cure ‐ stress urinary incontinence: A 26/35, B 14/32
Overactive bladder symptoms, voiding, dyspareunia
Total vaginal length: A 7.9 cm, B 4.7 cm

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated

Allocation concealment (selection bias)

High risk

Inadequate: computer‐generated randomisation by an open list

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not stated

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not stated

Incomplete outcome data (attrition bias)
All outcomes

Low risk

AC group 33/34 (97%), Burch colposuspension 35/37 (95%)

Selective reporting (reporting bias)

Low risk

Main outcomes reported

Other bias

Unclear risk

Not stated

Dahlgren 2011

Methods

Multi‐centre (8), Swedish open RCT

Computer‐generated block randomisation stratified for each centre

Allocation concealment by opaque sealed envelopes

SS 160 would allow 90% power to detect 15% difference between groups with 5% alpha error and dropout rate of 10%

3‐Year review

Intention to treat and CONSORT not stated

Participants

Inclusion: recurrent (prior surgery on prolapsing site) POP in anterior and/or posterior compartment

No exclusion criteria

135 randomised

Gp A native tissue repair 66, 3 years 60/66

Gp B porcine dermis repair 65, 3 years 65/68

Interventions

Standardised surgery with 2 meeting workshops before the study

Native tissue repair; midline fascial plication with interrupted polydioxanone suture, vagina closed with polyglactin absorbable suture

Porcine: porcine dermal implant (Pelvicol, Bard, Sweden) as inlay with no fascial plication: inlay anchored to vaginal wall and fascia with 6‐8 polydioxanone suture, vagina closed with polyglactin suture

Concomitant MUS, apical support and levator plication performed as required

Outcomes

Assessed at 3 months and 3 years

Reported the following review outcomes

  1. Awareness of prolapse (awareness of vaginal lump) at 3 years (presented in graph)

  2. Objective failure posterior compartment (pt Bp median and range reported)

  3. Bladder function (urinary incontinence presented in graph)

  4. Bowel function (faecal incontinence presented in graph)

  5. Dyspareunia (presented in graph)

  6. Days in hospital (mean and range)

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated blocked randomisation list stratified for each centre

Allocation concealment (selection bias)

Unclear risk

Sealed opaque envelopes (unclear if consecutive)

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Nil

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not stated

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Gp A 60/68, Gp B 65/68 completed 3‐year review

Selective reporting (reporting bias)

Low risk

Main outcome data reported

Other bias

Low risk

No COI; funded by local research institutes

De Ridder 2004 abstract

Methods

RCT (unclear randomisation and concealment)
Pelvicol vs Vicryl for stage 3 cystocele repair
Follow‐up: 25/26 months

Participants

134 included
A 65, B 69
Inclusion: stage 3 cystocele

Interventions

A (65): Raz 4 defect cystocele repair reinforced with porcine dermis overlay (Pelvicol)
B (69): as above, reinforced with Vicryl
Concomitant surgery: vaginal hysterectomy and rectocele repair

Outcomes

Primary outcome: recurrence of cystocele stage 2: A 6/63, B 19/62 (P = 0.002)
Number having repeat prolapse surgery: A 3/63, B 9/62
No differences in questionnaires

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not stated

Allocation concealment (selection bias)

Unclear risk

Unclear method

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not stated

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not stated

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Not stated

Selective reporting (reporting bias)

Low risk

Outcome data reported

Other bias

Unclear risk

Not stated

De Tayrac 2013

Methods

Multi‐centre (12 French hospitals) RCT

12‐Month review

Randomisation by drawing lots, stratified by centre

Allocation concealment not discussed

Intention to treat stated yes, but participants already randomised were removed if cystotomy occurred during surgery

CONSORT guidelines

Sample size of 194 provided 80% power to detect 20% difference with 5% alpha error and dropout rate of 10%

Assessors not clear

Participants

Inclusion criteria: symptomatic stage 2 anterior wall prolapse, 60 years of age or older

Exclusion criteria: steroids, poorly controlled diabetes, prior pelvic radiation, untreated vaginal or urinary infection, ascites, bladder injury during procedure

All used preoperative oestrogen therapy

163 included, 162 randomised

Gp A (82): 1 year 67/82

Gp B (80): 1 year 66/60

Preop demographics and potential confounders similar in both groups, except colorectal impact greater in AC group

Interventions

Gp A anterior colporrhaphy (AC): no mesh (plication of fascia with 2.0 polyglactin absorbable suture), uterosacral colpopexy and hysterectomy as required

Gp B anterior polypropylene: macroporous mesh (Ugtex, Sofradim, Covidien), 4‐armed transobturator mesh, fixed with 2 × 2.0 permanent polypropylene sutures to uterine isthmus or uterosacral ligaments and 2 × 2.0 polyglactin sutures to inferior edge of pubic rami, vaginal trimming minimised

Concomitant surgery: MUS, hysterectomy and any native tissue repair, but no other transvaginal mesh intervention included

Outcomes

Assessed at 1‐year follow‐up

Reported the following review outcomes

  1. Awareness of prolapse ("functional recurrence")

  2. Repeat continence surgery

  3. Repeat surgery for prolapse, SUI or mesh exposure

  4. Recurrent prolapse: stage 2 or greater anterior prolapse

  5. Mesh exposure

  6. Repeat surgery for mesh exposure

  7. Objective failure of anterior compartment

  8. POPQ assessment of prolapse: point Ba

  9. POPQ assessment of prolapse: total vaginal length

  10. Bladder function: de novo SUI

  11. Bowel function: obstructed defecation

  12. Sexual function: de novo dyspareunia

  13. Operating time

  14. Blood transfusion

  15. Days in hospital

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Randomisation by drawing lots?

Allocation concealment (selection bias)

Unclear risk

Not stated

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Unable to blind

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not stated

Incomplete outcome data (attrition bias)
All outcomes

High risk

Gp A 82, 1 year 67/82

Gp B 80, 1 year 66/80, 20% attrition

Selective reporting (reporting bias)

Low risk

Main outcome data reported

Other bias

High risk

Study author COI with Sofradim, which provided partial funding and whose product was being evaluated

Delroy 2013

Methods

Single‐centre non‐inferiority RCT

Computer‐generated random number list

Allocation at inclusion with surgeon aware only in OT

Envelope allocation

Sample size; 35 in each group, 80% power to detect 5% significant change with 10% dropout

Intention‐to‐treat analysis

Assessors blinded

Participants unblinded

Participants

Any anterior POP point Ba ≥ +1 on POPQ

Excluded malignant urogenital disease, prior radiation, acute genitourinary infection, connective tissue disorders, steroid treatments, insulin‐dependent diabetes

Interventions

All procedures performed under spinal by 3 experienced surgeons

AC: Plicate fascia pursestring Vicryl 0, vaginal trimming, transvaginal Trocar‐guided polypropylene mesh (kits donated by Promedon), Nazca TC (Promedon, Corboda, Argentina), prepubic and 2 transobturator macroporous monofilaments, vagina closed in overlapping fashion

355 accessed, 79 randomised

AC: 39 completed 1‐year review

Anterior mesh: 40 randomised, 40 completed 1‐year review

Concomitant surgery as required

Outcomes

Assessed at 1 year

Reported the following review outcomes

  1. Awareness of prolapse: positive answer to at least 1 PQOL question on vaginal bulge, pelvic pain, sensation of prolapse (unusual combined measure ‐ data not used)

  2. Mesh exposure

  3. Bladder injury

  4. POPQ assessment of prolapse: points Ba, C, Bp; total vaginal length

  5. Sexual function: de novo dyspareunia

  6. Operating time

  7. Blood transfusion

  8. Days in hospital

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random sequence generation tables

Allocation concealment (selection bias)

Unclear risk

Envelopes (opaque?, sealed?)

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Non‐blinded

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Blinded assessors

Incomplete outcome data (attrition bias)
All outcomes

Low risk

79 randomised; all completed 1‐year review

Selective reporting (reporting bias)

Low risk

Most outcome data reported

Other bias

Low risk

Funded by Federal university of Sao Paulo, Brazil; Promedon contributed product free of charge

No author COI reported

El‐Nazer 2007

Methods

Single‐centre RCT for stage 2 POPQ prolapse

PC‐generated randomisation

2‐Year follow‐up

No CONSORT statement

Blinding not stated

Power of 80%, need sample size of 20 in each arm if subsequent prolapse surgery in 1 group 11% and 44% in mesh group

Participants

40 randomised

Inclusion criteria: stage 2 POPQ cystocele with no plans for pregnancy in 12 months

Exclusion criteria: contemplating pregnancy, patients with paravaginal defects, need for continence surgery, prior colposuspension or vaginal surgery, immunocompromised, diabetic

Interventions

A (23): anterior colporrhaphy AC 0 polyglactin Vicryl suture

B (21): self‐styled armless soft polypropylene (Gynemesh) mesh without AC

Outcomes

Assessed at 6 weeks, 3 months, then every 6 months to 2 years postop

Reported the following review outcomes

  1. Awareness of prolapse (subjective persistence of symptom of vaginal bulge)

  2. Recurrent prolapse at 1 to 3 years

  3. Mesh erosion

  4. Bladder injury (cystotomy)

  5. Objective failure rate stage 2 POPQ at Aa, Ba, Ap or Bp

  6. Bladder function (de novo SUI)

  7. Sexual function (de novo dyspareunia)

  8. Quality of life: PQOL questionnaire, change scores

  9. Hospital stay

  10. Operating time

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

PC‐generated randomised number tables

Allocation concealment (selection bias)

Unclear risk

Sealed envelopes to ensure allocation concealment: as not consecutive, rated as unclear

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not stated

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Reviewers blinded

Incomplete outcome data (attrition bias)
All outcomes

Low risk

At 1 year, completed review; no mesh 20/23, mesh 20/21

Selective reporting (reporting bias)

Low risk

Main outcome reported

Other bias

Unclear risk

Funding not stated; study authors reported no COI

Farthmann 2012

Methods

Prospective open‐label RCT, multi‐centre (n = 6)

3 years

Randomisation and allocation concealment not stated

CONSORT and intention to treat, no

Participants

Inclusion: cystocele greater than or equal to stage 2, with risk factors of recurrent prolapse, overweight, COPD, chronic obstipation

Exclusion: younger than 18 years, not completed family, allergy to polypropylene, prior mesh; prior cancer of lower urinary tract, genital organs, rectosigmoid

200 randomised, 177/200 at 3 years

Interventions

GP A: partially absorbable polypropylene mesh (Seratom, Germany), coated in polyglycolic acid and caprolactone, which is absorbed at 120 days, leaving light weight of 17 g/m2

GP B: polypropylene mesh, 6 arms, 29 g/m2

Concomitant surgery performed

Outcomes

Review outcomes at 3 years

  1. Repeat surgery for prolapse

  2. Recurrent prolapse examination (any site)

  3. Recurrent anterior wall prolapse (stage 2)

  4. Posterior wall prolapse

  5. Mesh exposure

  6. Surgery mesh exposure

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random allocation, computer generated, stratified for each centre

Allocation concealment (selection bias)

Unclear risk

Not stated

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Not performed

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Not performed

Incomplete outcome data (attrition bias)
All outcomes

Low risk

175/200 at 3 years, groups

Gp A: partially absorbable polypropylene mesh 89/97 (92%); Gp B: polypropylene mesh 86/102 (84%)

Selective reporting (reporting bias)

Low risk

Main outcome data reported

Other bias

High risk

Study sponsored by company whose product was evaluated; unblinded reviewers had COI with the company whose product was being evaluated (Serag‐Wiessner, Naila, Germany)

Feldner 2010

Methods

Single‐centre RCT

Randomisation and allocation concealment described

Evaluated 1 year after anterior colporrhaphy (AC) as compared with small intestine submocosa graft

Blinded reviewers

Participants

Inclusion criteria: women with point Ba ≥ ‐1

Exclusion criteria: those with hypertension, prior radiation, pelvic sepsis, diabetes and chronic illness

Concomitant surgery allowed, including vaginal hysterectomy, if greater than stage 2 uterine prolapse

Interventions

Gp A (27): anterior colporrhaphy with interrupted 0 Vicryl sutures

Gp B (29): non‐cross‐linked xenograft porcine small intestine submucosa 7 × 10 cm, with dissection to suprapubic arch, fixed with 0 prolene ×3 each side

Outcomes

Assessed at 1 year

Reported the following review outcomes at 1 year

  1. Repeat prolapse surgery (no events)

  2. Recurrent prolapse (at point Ba)

  3. Mesh exposure (no events)

  4. Dyspareunia (any ‐ no separate data for de novo)

  5. POPQ assessment of prolapse: points Ba, C, Bp; total vaginal length

  6. Quality of life: PQOL questionnaire end scores

  7. Operating time

Notes

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

Allocation concealment appropriate

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not stated

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Blinded reviewers and participant‐completed validated questionnaires

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Data well described: 1 year AC 27/27, SIS 29/29

Selective reporting (reporting bias)

Low risk

Significant outcome data reported

Other bias

Low risk

No COI and no external funding

Gandhi 2005

Methods

Single‐centre RCT (computer generated, opaque envelopes, adequate concealment)
Anterior colporrhaphy with and without fascia lata for primary or recurrent anterior vaginal wall prolapse

Participants

162 signed consent form
154 randomised
A 76, B 78
Loss to follow‐up: 2 in B, but in results, 78 and 77 analysed
Inclusion: anterior vaginal wall prolapse to hymen or beyond on straining, > 18 years of age, willing to comply with return visits
Concomitant surgery: vaginal hysterectomy in 49%/47%, sacrospinous fixation in 43%/42% (all cases with vaginal vault prolapse to mid‐vagina or beyond), posterior repair in 99%/94%, Coopers' ligament sling in 67%/55%, mid‐urethral sling in 13%/10%
Enterocele: A 75%, B 73%
Baseline voiding dysfunction (slow stream): A 48/68, B 42/65

Interventions

A (76): "ultra‐lateral" midline plication of anterior endopelvic connective tissue using Vicryl buttress sutures (as described by Weber 2001), plus additional cadaveric fascia lata patch (Tutoplast) anchored at the lateral limits of the colporrhaphy
B (78): as above without allograft

Outcomes

Assessed at 1 year

Reported the following review outcomes

  1. Awareness of prolapse (vaginal bulging)

  2. Recurrent prolapse (POPQ stage 2 anterior prolapse)

  3. Objective failure of anterior compartment (same data as recurrent prolapse)

  4. Bladder function: postvoid fullness

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated

Allocation concealment (selection bias)

Low risk

Sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not stated

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not stated

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Data complete at 1 year: AC 76/78 (97%), biological 76/76

Selective reporting (reporting bias)

Low risk

Main outcome reported

Other bias

Unclear risk

No COI and no funding statement

Guerette 2009

Methods

Multi‐centre RCT

24‐Month follow‐up

Randomisation computer generated

Allocation concealment without blinding of participants or surgeon

Not according to CONSORT

Participants

Randomised: Gp A 47, Gp B 47

2 years: Gp A 33, Gp B 26

Examination: A 27, B 17

Inclusion criteria: point Ba ≥ ‐1,

Exclusion criteria: TVL < 6 cm, severe atrophy, isolated paravaginal defect, allergic bovine material

prior vaginal implant surgery, those with ulceration

Interventions

A (46): anterior colporrhaphy

B (44): anterior colporrhaphy with bovine pericardium collagen matrix graft reinforcement

Outcomes

Assessed at 6 months, 1 year and 2 years

Reported the following review outcomes

  1. Awareness of prolapse: measure unclear

  2. Repeat surgery for prolapse

  3. Graft erosion/exposure ‐ no events

  4. POPQ assessment of prolapse: points Ba, C (reported median and range, no SDs)

  5. Sexual function: PISQ‐12 (no SDs reported); de novo dyspareunia at 1 year

  6. Quality of life: UDI‐6 (no SDs reported)

  7. Operating time ‐ reported as median and range

Notes

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

Opaque envelopes

Blinding of participants and personnel (performance bias)
All outcomes

High risk

No blinding

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not stated whether assessors were blinded, participant‐completed questionnaire

Incomplete outcome data (attrition bias)
All outcomes

High risk

Equal losses in both groups, only 50% at 2‐year review: AC 33/47: biological 26/47

Selective reporting (reporting bias)

Low risk

Main outcome data reported

Other bias

High risk

Extensive COI reported: study funded in part by Synovis Life Technology, whose product was being evaluated ‐ bovine pericardium

Gupta 2014

Methods

Single‐centre RCT, India; computer‐generated randomisation

Allocation concealment ‐ not stated

Blinding of participants and reviewers ‐ not stated

Sample size 106, with 80% power to detect 21% difference between groups, with 5% type 1 error

Participants

Inclusion: stage 2 or greater anterior compartment prolapse

Exclusion: SUI, dominant post vaginal prolapse; suspected malignancy; vaginal infection

Interventions

Group A: anterior colporrhaphy, 2.0 Vicryl (n = 54), 1 year (n = 41)

Group B: self‐styled, 4 arms, monofilament polypropylene mesh (Vypro mesh, J&J) (n = 52), 1 year (n = 44)

Outcomes

Assessed at 6 months, 1 year

Reported the following review outcomes

  1. Awareness of prolapse (vaginal bulge) at 1 year

  2. Repeat prolapse (anterior)

  3. Mesh erosion

  4. Surgery for mesh exposure

  5. Objective failure of anterior compartment (cystocele)

  6. Operating time

  7. Blood transfusion

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated randomisation

Allocation concealment (selection bias)

Unclear risk

Not stated

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not stated

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not stated

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Gp A 41/54 (76%), Gp B 44/52 (87%), at 1 year

Selective reporting (reporting bias)

Low risk

Significant outcome data

Other bias

Unclear risk

No statement

Hviid 2010

Methods

Single‐centre RCT

Computer‐generated randomisation and allocation concealment were appropriate, with sealed envelopes opened in operating room

Reviews by non‐blinded surgeon

No concomitant surgery

80% power to detect 20% difference, 5% type 1 error

Participants

Inclusion criteria: symptomatic prolapse, point Ba ≥ ‐1; defects in posterior or apical compartment; prior pelvic surgery;

Exclusion: history of collagen or endocrine disorders

Allocated: Gp A 31, Gp B 30

1 year: A 26, B 28

Interventions

A (31): 2.0 interrupted Vicryl plication

B (30): no plication, Pelvicol porcine dermis 4 × 7 cm anchored with 2.0 Vicryl sutures

No concomitant surgery

Outcomes

Assessed at 1 year

Reported the following review outcomes

  1. Repeat prolapse surgery

  2. Awareness of prolapse (vaginal bulging or lump)

  3. Recurrence of prolapse (POPQ Ba ≥ ‐1.0)

  4. Repeat surgery for incontinence

  5. Objective failure of anterior compartment

  6. POPQ assessment of prolapse: point Ba at 12 months (stated median and range)

  7. Quality of life: King's Health Questionnaire (graphical results and P values only)

  8. Opearting time

Notes

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

Sealed non‐transparent sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not stated

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Reviewers non‐blinded, participant‐completed questionnaires

Incomplete outcome data (attrition bias)
All outcomes

Low risk

At 1 year: AC 26/31 (84%), biological 28/30 (93%)

Selective reporting (reporting bias)

Low risk

Significant outcome data

Other bias

Unclear risk

No COI declared, no statement on funding

Lamblin 2014

Methods

Single‐centre RCT, France

Computer‐generated 6‐block randomisation

Allocation concealment not stated

Blinding ‐ no participants or reviewers

Intention to treat not stated

Participants

Inclusion: stage 3 or greater anterior compartment prolapse

Exclusion: pregnancy, family not completed, prior cancer or radiation, poorly controlled DM, polypropylene sensitivity, immunocompromised

Concomitant surgery performed

Interventions

Gp A: AC with bilateral vaginal colposuspension (Ethibond suture) (n = 35), at 2 years (n = 32)

Gp B: polypropylene transobturator mesh (Perigee AMS) (n = 33), at 2 years (n = 31)

More women underwent hysterectomy in the colposuspension group (77%) than in the mesh group (33%), P < 0.001

Outcomes

Assessed at 3 months, 1 year and 2 years

Reported the following review outcomes at 2 years

  1. Awareness of prolapse at 2 years (vaginal bulge or something falling out)

  2. Repeat continence surgery

  3. Repeat prolapse, SUI or mesh exposure surgery

  4. Recurrence of prolapse (POPQ Ba > 1.0)

  5. Mesh exposure

  6. Bladder injury (no events)

  7. Surgery for mesh exposure

  8. POPQ assessment of prolapse: point Ba

  9. Sexual function: de novo dyspareunia (1 vs 1)

  10. Quality of life: PFIQ (end scores)

  11. Operating time

  12. Blood transfusion (no events)

  13. Hospital stay

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated randomisation list

Allocation concealment (selection bias)

Unclear risk

Not stated

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not stated

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not stated

Incomplete outcome data (attrition bias)
All outcomes

Low risk

At 2 years: Gp A 32/35 (91%), Gp B 31/33 (94%)

Selective reporting (reporting bias)

Low risk

Significant outcome data

Other bias

Low risk

Funded by the Claude Bernard University. Study authors reported no COI.

Menefee 2011

Methods

Double‐blinded triple‐arm RCT

Randomisation, allocation concealment, NS power, 33 in each group, 80% power to detect 35% difference with 5% type 2 error

2‐Year review

Participants

Inclusion: women ≥ 18 years of age with a POPQ point Ba ≥ 0

Exclusion: NS

Concomitant surgery: hysterectomy, colpopexy, posterior repair, continence at surgeon's discretion

Interventions

99 randomised

A (32): standard anterior colporrhaphy using midline plication with delayed absorbable suture

B (31): vaginal paravaginal repair using free‐hand formed porcine dermis graft (Pelvicol)

C (36): vaginal/paravaginal repair using free‐formed polypropylene mesh (M). All graft material was secured to the arcus tendineus fascia pelvis by a Capio device with permanent monofilament suture

Outcomes

Assessed at 2 years

Reported the following review outcomes at 2 years

  1. Repeat surgery for prolapse

  2. Recurrence of prolapse (POPQ Ba stage 2 or greater)

  3. Bladder injury (no events)

  4. Mesh erosion

  5. Objective failure of anterior compartment

  6. Sexual function: de novo dyspareunia (data not used, as no denominator reported); PISQ‐12 (median and range)

  7. Quality of life: PFIQ (median and range)

  8. Operating time

  9. Blood transfusion (no events)

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated sequence

Allocation concealment (selection bias)

Low risk

Opaque envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Double‐blinded

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Double‐blinded

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Moderate attrition 1 year: AC 24/32 (75%) ‐ porcine 26/31 (84%), mesh 28/36 (77%)

Selective reporting (reporting bias)

Low risk

Significant outcome data

Other bias

High risk

Study authors reported COI with companies producing product evaluated; funding by Boston Scientific, whose product Capio was being evaluated

Meschia 2007

Methods

Multi‐centre RCT (computer generated) on primary surgery, anterior vaginal wall prolapse
Allocation concealed

Power calculation: 90 in each arm required

Follow‐up: 2 years

Intention‐to‐treat analysis: yes, including women with missing data at 2 years but with 1‐year follow up completed

Participants

206 randomised
Lost to follow‐up: 5 ‐ A 2, B 3
Inclusion: primary anterior prolapse, POPQ point Ba ‐1 (≥ stage 2)
Exclusion: none
Baseline stress urinary incontinence: A 22/100, B 18/106
Baseline overactive bladder: A 44/100, B 35/106
Baseline sexually active: A 65/100, B 74/106; with dyspareunia: A 12/65, B 11/74

No differences between the 2 groups with respect to demographic and clinical characteristics

At 2 years, number available for analysis: 176 (A 91, B 85)

Intention‐to‐treat analysis: 201 analysed (A 103, B 98)

Interventions

A (100): interrupted fascial plication Vicryl 00 WITH Pelvicol overlay, fixed with PDS suburethrally and uterosacral cardinal ligament distally
B (106): surgery as above WITHOUT Pelvicol overlay
Concomitant surgery standardised
Vaginal hysterectomy, McCall culdoplasty, posterior compartment defect, fascial plication

Outcomes

Assessed at 1 year

Reported the following review outcomes at 1 year

  1. Awareness of prolapse (sensation of prolapse)

  2. Objective failure of anterior compartment

  3. Bladder function: SUI

  4. Sexual function: dyspareunia

  5. Days in hospital

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated randomisation

Allocation concealment (selection bias)

Low risk

Adequate opaque envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not stated

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not stated; participant‐completed questionnaires

Incomplete outcome data (attrition bias)
All outcomes

Low risk

1 year: AC 101/106, 98/100

Selective reporting (reporting bias)

Low risk

Significant outcome data

Other bias

Unclear risk

No statement

Minassian 2010 abstract

Methods

Single‐centre 2‐surgeon RCT

Randomisation list PC generated and sealed opaque envelopes

32 in each group, 80% power to to detect 25% difference with 5% type 1 error

Participants and surgeons unblinded, along with who reviewed NS

2‐Year review

Intention‐to‐treat analysis

Participants

Inclusion criteria: women over the age of 18 with symptomatic cystoceles scheduled for reconstructive surgery

Exclusion criteria: pregnant or planning to have a future pregnancy, 2 previous failed anterior vaginal wall repairs

90 screened, 70 randomised

AC (34): 2 years (n = 25)

Paravaginal (33): 2 years (n = 25)

Interventions

A (34): AC ‐ plication of the cystocele in the midline was performed with 0‐polydioxanone interrupted mattress sutures over a polyglactin 910 (Vicryl) mesh within the imbricated fold of vaginal muscularis and adventitia

B (33): paravaginal defect repair, 0‐polydioxanone sutures were used to attach the pubovesical fascia to that of the obturator and pubococcygeus muscle, also over a Vicryl mesh

2 surgeons

Concomitant POP and continence surgery allowed

Most undergoing sacral colpopexy, 74% both groups, MUS 76% hysterectomy, AC group 25/34 (74%), paravaginal group 14/34 (42%); P = 0.01

Outcomes

2‐Year review

  1. Objective failure ≥ stage 2 POP anterior wall

  2. Anterior compartment prolapse (point Ba 2 years)

  3. Posterior compartment prolapse (stage 2 or greater)

Perioperative outcomes

  1. Blood loss, catheter and inpatient days reported, median (range)

  2. Cystotomy

  3. Bowel injury (no events)

  4. Repeat surgery for prolapse

  5. Repeat surgery for SUI

  6. Dyspareunia

  7. Quality of life questionnaires: Pelvic Floor Distress Inventory (PFDI), Pelvic Floor Impact Questionnaire (PFIQ), Prolapse and Incontinence Sexual Function Questionnaire (PISQ)

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated randomisation

Allocation concealment (selection bias)

Low risk

Sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Not blinded

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Not blinded

Incomplete outcome data (attrition bias)
All outcomes

High risk

AC group: 34 randomised, 25 at 2 years (73%)

Paravaginal repair: 33 randomised, 25 at 2 years (76%)

Selective reporting (reporting bias)

Low risk

Significant outcome data

Other bias

Low risk

No COI

Natale 2009

Methods

CONSORT statement: no

Power calculation: 100 in each arm

Type of randomisation: computer generated

Blinding strategy: not specified

Allocation concealment: not specified

Definition of cure: point Ba < ‐1 (i.e. stage 0 or 1 according to the POPQ system)

Follow‐up: 24 months

Prolapse assessment: POPQ

Update of Cervigni 2005 abstract

Participants

Inclusion: recurrent symptomatic stage 2 or greater anterior vaginal wall prolapse (point Ba ≥ ‐1), planning to undergo secondary pelvic reconstructive surgery

Exclusion: need for concomitant anti‐incontinence procedure, diabetes mellitus or collagen disease

Randomised: 190

Analysed: 190

Women were comparable at baseline in terms of demographic data, degree of POP and clinical or urodynamic findings. Previous hysterectomy: A 60/96, B 54/94

Interventions

A (96): cystocele repair with armed monofilament polypropylene mesh (Gynemesh)

B (94): cystocele repair with armed porcine dermis graft (Pelvicol)

Concomitant surgery: not specified. Prophylactic antibiotic cover

All underwent tension‐free cystocele repair (TCR) and levator myorrhaphy and vaginal hysterectomy, if required

Sheets of both Pelvicol graft and synthetic mesh were trimmed to an identical rounded shape, with 2 lateral wings/arms. In each operation, the central, rounded portion of the graft was positioned under the urinary bladder in a tension‐free fashion, while its arms were inserted deep into the periurethral tissue on both sides towards the pubic bone. A single fixating Monocryl 2/0 suture was performed at the base of 1 wing of mesh, at the periurethral level

Outcomes

2‐Year outcomes (3‐year abstract for objective failure rate)

  1. Objective failure anterior (stage 2 or greater)

  2. De novo SUI

  3. Dyspareunia

  4. OAB

  5. Quality of life PISQ and PQOL

  6. Surgery for mesh erosion

Notes

Trialists concluded that Gynemesh was not statistically significantly superior to porcine graft in the management of anterior compartment prolapse at 2 years. Sexuality and PQOL were superior in the porcine graft group as compared with the Gynemesh PS group

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated

Allocation concealment (selection bias)

Unclear risk

Not stated

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not stated

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not stated

Incomplete outcome data (attrition bias)
All outcomes

Low risk

2‐Year mesh 96/96, Pelvicol 94/94

Selective reporting (reporting bias)

Low risk

Significant outcome data

Other bias

Unclear risk

No statement

Nguyen 2008

Methods

Single‐centre RCT on anterior vaginal prolapse

CONSORT statement: yes

Power calculation: 38 in each arm

Type of randomisation: computer generated

Blinding strategy: primary surgeon ‐ until the surgery day; patients, research nurse and medical assistant remained blinded

Allocation concealment: sealed opaque envelopes

Definition of cure

  1. Anterior wall POPQ at stage < 2, ‘Optimal support’ = Aa and Ba at stage 0, ‘Satisfactory’ = Aa and Ba at stage 1 and improved from preop staging

Follow‐up: 12 months (full publication) and 24 months (abstract only)

Prolapse assessment: POPQ

Participants

Inclusion: 21 years old and older with POPQ stage 2 or greater anterior prolapse requiring surgical correction

Exclusion: pregnancy (present or contemplated), prior repair with graft, systemic infection, compromised immune system, uncontrolled diabetes mellitus, previous pelvic irradiation/cancer, polypropylene allergy, scheduled for concomitant Burch or pubovaginal sling

Randomised: 76

Withdrawal: 1

Lost to follow‐up: 1

Analysed: 76

Interventions

A (38): anterior colporrhaphy (AC) with delayed absorbable (PDS) sutures

B (38): AC + polypropylene 4‐armed mesh kit repair (Perigee, American Medical Systems)

Concomitant surgery: vaginal hysterectomy, bilateral salpingo‐oophorectomy, uterosacral suspension, mid‐urethral tape, site‐specific rectocele repair, perineoplasty, Apogee mesh kit repair

Concomitant prolapse and suburethral tape surgeries were performed in both groups

Outcomes

Assessed at 1 year

Reported the following review outcomes at 1 year

  1. Repeat prolapse surgery

  2. Recurrent prolapse (anterior prolapse stage 2 or greater)

  3. Death (no events)

  4. Mesh exposure

  5. Objective failure of anterior compartment

  6. POPQ assessment of prolapse: points Ba, C, Bp; vaginal length (reported median and range)

  7. Sexual function: de novo dyspareunia; PISQ

  8. Quality of life: PFIQ (and other measures) ‐ end scores

  9. Operating time (median and range)

  10. Blood transfusion

  11. Days in hospital (median and range)

Notes

Data regarding study methods were obtained from the full published article, with follow‐up at 12 months

PFDI ‐ Pelvic Floor Distress Inventory (quality of life measure)

PFIQ ‐ Pelvic Floor Incontinence Questionnaire (quality of life measure)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated randomisation

Allocation concealment (selection bias)

Low risk

Sealed opaque envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Participants blinded

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Assessors blinded; participant‐completed questionnaires

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Data set complete: AC 37/38, mesh 37/38

Selective reporting (reporting bias)

Low risk

Significant outcome data

Other bias

Unclear risk

No statement

Nieminen 2008

Methods

Muti‐centre RCT on anterior vaginal prolapse

CONSORT statement: yes

Power calculation: 101 in each arm

Type of randomisation: computer generated

Allocation concealment: opaque envelopes

Blinding strategy: not specified, but lack of a non‐surgical blinded outcome reviewer

Definition of cure: less than stage 2 prolapse at Aa or Ba

Follow‐up: 24 months

Prolapse assessment: POPQ

Participants

Inclusion: postmenopausal women with symptomatic anterior vaginal wall prolapse to the hymen or beyond

Exclusion: apical defect indicating vaginal fixation or stress urinary incontinence necessitating surgery, or main symptomatic prolapse component in the posterior vaginal wall. Also, gynaecological tumour or malignancy calling for laparotomy or laparoscopy and untreated vaginal infection

Randomised: 202

Withdrawal: 1

Lost to follow‐up: 1

Analysed: 200

No significant differences in baseline demographics, prior hysterectomy or prolapse surgeries between the 2 groups

Interventions

A (96): anterior colporrhaphy (AC) with a 0 or 2/0 multi‐filament suture

B (104): AC + self‐tailored (from a 6 × 11 cm mesh patch), 4‐armed low‐weight polypropylene mesh

Type of mesh: non‐absorbable monofilament polypropylene (Parietene Light, Sofradim, France)

Sutures for AC: absorbable 0 or 2/0 multi‐filament suture

Concomitant surgery: vaginal hysterectomy, posterior repair, culdoplasty as required, no concomitant continence surgeries

Outcomes

Assessed at 2 months and 1, 2 and 3 years

Reported the following review outcomes at 3 years

  1. Awareness of prolapse (bulge)

  2. Repeat prolapse surgery

  3. Repeat continence surgery

  4. Recurrent prolapse (any compartment stage 2 or greater)

  5. Mesh exposure

  6. Bladder injury

  7. Repeat surgery for mesh exposure

  8. Objective failure of anterior compartment

  9. POPQ assessment of prolapse: points Ba, C; vaginal length

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated randomisation

Allocation concealment (selection bias)

Low risk

Sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not stated

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not stated

Incomplete outcome data (attrition bias)
All outcomes

Low risk

2‐Year AC 85/96 (88%), mesh 97/104 (93%)

Selective reporting (reporting bias)

Low risk

Significant outcome data

Other bias

Unclear risk

Not clear

Robert 2014

Methods

Parallel‐group RCT

Participants

Included: women with a cystocele requiring surgical management

Excluded: allergy to graft material, immunocompromised, non‐English speaking, unavailable for follow‐up

Concomitant surgery and previous non‐anterior prolapse surgery were not exclusion criteria

Interventions

Small intestine mesh‐augmented procedure vs same anterior repair without mesh

Outcomes

Assessed at 1 year

Reported the following review outcomes at 1 year

  1. Awareness of prolapse (bulge)

  2. Recurrent anterior prolapse (stage 2 or greater prolapse)

  3. POPQ assessment of prolapse: point Ba (reported change from baseline as median and range)

  4. Sexual function: PISQ‐12 (reported change from baseline as median and range)

  5. Quality of life: PFDI (reported change from baseline as median and range)

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Centralised randomisation through data manager

Allocation concealment (selection bias)

Unclear risk

Methods not described

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Participants blinded to treatment allocation

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Follow‐up performed by blinded clinician blinded to allocation, with no involvement in participant care

Incomplete outcome data (attrition bias)
All outcomes

Low risk

55/57 women randomised (96%) and included in analysis for objective cure, 57/57 (100%) for subjective outcomes

Selective reporting (reporting bias)

Low risk

Reported expected outcomes

Other bias

Low risk

Supplier of product (Cook) partially funded the study, but double‐blinding overcame potential biases

Rudnicki 2014

Methods

Multi‐centre (6) international RCT, Nordic countries ‐ Norway, Sweden, Denmark and Finland

Block computer‐generated randomisation list

Allocation concealment, opaque sealed envelopes

Intention‐to‐treat analysis

Sample size: 130 participants allowed, 80% power to detect 20% difference with an alpha error of 5% and a dropout rate of 15%

Assessors: surgeons

Participants: unblinded

Surgeons trained (?) to ensure that uniform surgery was performed

Participants

Inclusion criteria: ≥ 55 years, anterior wall prolapse stage 2, POPQ Aa or Ba ≥ ‐1

Exclusion criteria: previous major pelvic surgery, with the exception of a hysterectomy for reasons other than genital prolapse; previous vaginal surgery or hysterectomy for POP; concomitant prolapse of the uterus or an enterocele of stage 1 or greater; previous incontinence sling surgery performed through the obturator membrane; current treatment with corticosteroids; history of genital or abdominal cancer

All surgery covered with intraoperative antibiotics and presurgical and postsurgical local oestrogens

Concomitant surgery allowed posterior repair

Interventions

AC group: interrupted absorbable suture fascial plication, vaginal trimming and closure with running unlocked absorbable suture

Mesh: biosynthetic system monofilament polypropylene mesh with central portion coated in absorbable hydrophilic porcine collagen film (Bard, Avulta Plus anterior)

169 available for randomisation, with 161 randomised

AC (79): randomised, 1 year ‐ 76

Mesh (82): randomised, 1 year ‐ 78

Outcomes

Assessed at 3 months, 1 year and 3 years

Reported the following review outcomes at 1 year

  1. Awareness of prolapse (vaginal bulge) (only P value reported)

  2. Recurrent prolapse (POPQ stage 2 or greater)

  3. Mesh exposure

  4. Bladder injury (perforation)

  5. Surgery for mesh exposure

  6. POPQ assessment of prolapse: points Ba, C, Bp; total vaginal length

  7. Bladder function: de novo stress incontinence

  8. Sexual function: PISQ, de novo dyspareunia

  9. Quality of life: PFIQ, PFDI

  10. Operating time

  11. Blood transfusion

  12. Days in hospital (over 12‐hour stay)

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Blocked computer‐generated randomisation list for each of 4 countries

Allocation concealment (selection bias)

Low risk

Sealed opaque envelopes

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Unblinded

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Surgeons evaluated

Incomplete outcome data (attrition bias)
All outcomes

Low risk

1‐Year evaluation, randomised

AC 76/79 (96%), mesh 78/82 (95%)

Selective reporting (reporting bias)

Low risk

Significant outcome data

Other bias

Unclear risk

No COI

Sand 2001

Methods

Single‐centre RCT (computer‐generated number table)
Vaginal repair with or without Vicryl mesh overlay for cystocele and rectocele
Follow‐up: A 12, B 12 months

Participants

143 women
Inclusion: cystocele to or beyond hymenal ring on standing
Exclusion: younger than 18 years of age, pregnancy, contemplating pregnancy within 1 year, paravaginal defect only, anterior enterocele
161 randomised
1 excluded (anterior enterocele)
17 lost to follow‐up

Interventions

A (70): no mesh ‐ Vicryl plication of anterior endopelvic fascia
B (73): mesh ‐ as above with Vicryl mesh folded underneath trigone and cuff and secured Vicryl to fascia; also added to posterior wall if posterior repair performed
Posterior repair performed: A 67/70, B 65/73

Outcomes

Assessed at 2, 6 and 12 weeks and at 1 year

Reported the following review outcomes at 1 year

  1. Recurrent prolapse (grade 2 or 3 cystocele or rectocele on BW scale)

  2. Mesh erosion (no events)

Notes

No subjective success
No urinary, bowel or sexual function data
No perioperative data
No intention‐to‐treat analysis
No CONSORT
No blinding
Standardised concomitant surgery
Review by surgeon

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated

Allocation concealment (selection bias)

Unclear risk

Unclear

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not stated

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not stated

Incomplete outcome data (attrition bias)
All outcomes

Low risk

143/170 (84%) completed 1‐year review

Selective reporting (reporting bias)

Unclear risk

Not stated

Other bias

Unclear risk

No conflict of interest statement

Sivaslioglu 2008

Methods

Single‐centre RCT comparing polypropylene mesh surgery with site‐specific surgery in the treatment of patients with cystocoele

CONSORT statement: yes

Power calculation: 45 in each arm

Type of randomisation: computer generated

Blinding strategy: no (assessment was performed by non‐blinded reviewers)

Allocation concealment: not specified

Definition of cure/failure: 'Acceptable cure' defined as cystocele less than ‐1 cm (stage 1 POPQ)

Follow‐up: mean 12 months (range 8 to 16)

Prolapse assessment: POPQ

Participants

Inclusion: primary cystocele

Exclusion: stress urinary incontinence, concomitant rectocele or enterocoele or recurrent cystocoele

Randomised: 90 (45 to each arm)

Analysed: 85

Lost to follow‐up: 5

Interventions

A (42): site‐specific polyglactin 910 anterior repair

B (43): self‐styled 4‐armed polypropylene (Parietene, Sofradim, France) mesh, no anterior repair

Concomitant surgery not standardised, management of concomitant apical prolapse not specified in either group

Outcomes

Assessed at 6 weeks, 6 months and annually

Reported the following review outcomes at mean follow‐up of 1 year (range 8 to 16 months)

  1. Recurrent prolapse (stage 2 or greater POPQ)

  2. Mesh erosion

  3. Surgery for mesh erosion

  4. POPQ assessment of points Ba, C, Bp; total vaginal length (P values only)

  5. Bladder function: de novo SUI

  6. Sexual function: de novo dyspareunia

  7. Quality of life: PQOL end score

Notes

Sivaslioglu and colleagues evaluated a site‐specific polyglactin 910 repair and self‐styled 4‐armed polypropylene (Parietene, Sofradim) mesh

Management of concomitant apical prolapse was not specified in either group, and assessment was performed by non‐blinded reviewers. Three patients in the AC group developed de novo SUI, and 2 in the mesh group developed de novo dyspareunia. Operating time and blood loss were not described

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated

Allocation concealment (selection bias)

Unclear risk

Not stated

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not stated

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Non‐blinded reviewers' objective assessment, participant‐completed questionnaires

Incomplete outcome data (attrition bias)
All outcomes

Low risk

AC 42/45, mesh 43/45

Selective reporting (reporting bias)

Low risk

Significant outcome data

Other bias

Low risk

No funding and no COI

Tamanini 2015

Methods

Single‐unit raffle randomisation before surgery

No allocation concealment described

Surgeons and participants unblinded

Unclear who performed assessments (blinded?)

Sample size: 100 women, 80% power to detect 26% difference between groups with alpha error of 5% and 20% loss to follow‐up at 2 years

Participants

122 reviewed, 100 randomised

AC (55): 1 year 54, 2 year 50

Mesh (45): 1 year 43, 2 year 42

Inclusion criteria: 45 years old or older, AVWP ≥ 2 (POPQ stage) (7) without previous surgical correction or with previous surgical treatment of AVWP without the use of PM

Exclusion criteria: previous treatment (due to AVWP or SUI) with PM, receiving oncological treatment, altered Papanicolau smear exam or uterine bleeding, genital or acute urinary infection, lack of commitment to ambulatory follow‐up, refusal to sign informed consent

All preop urodynamics

Interventions

Spinal anaesthesia with antibiotics

NAZCA TC Kit (Promedon, Cordoba, Argentina), monofilament macroporous, 4 arms (1 prepubic and 1 transobturator each side), concomitant surgery as required: hysterectomy, apical or posterior repair

AC group: 2.0 Vicryl fascial plication mid‐urethral sling if SUI on preop UDS (14/55)

Outcomes

Assessed at 1 year and 2 years

Reported the following review outcomes at 2 years

  1. Repeat prolapse surgery (no events)

  2. Recurrent prolapse: anterior vaginal wall (POPQ Ba stage 2 or greater)

  3. Mesh exposure

  4. Surgery for mesh exposure

  5. Objective failure of anterior compartment (POPQ Ba stage 2 or greater)

  6. PoPq point C

  7. Dyspareunia

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Raffle randomisation: 55 in AC, 45 in mesh

Allocation concealment (selection bias)

High risk

No allocation concealment

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Unblinded

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Unblinded

Incomplete outcome data (attrition bias)
All outcomes

High risk

AC group: 42/55 at 2 years (76%)

Mesh group: 42/45 completed (93%), high risk due to disparity between groups

Selective reporting (reporting bias)

Unclear risk

Significant outcome data

Other bias

Low risk

No COI

Thijs 2010 abstract

Methods

Multi‐centre and multi‐national RCT

Randomisation and allocation concealment NS

90% power to detect 20% difference, urinary distress inventory prolapse domain at 1 year with 5% type 1 error, with 38 in each group

Participants

A (48): anterior colporrhaphy

B (48): Perigee transobturator polypropylene mesh

A (35): AC only, 5 SSF, 5 hysterectomy, 6 mid‐urethral sling

B (34): Perigee only, 4 SSF, 8 hysterectomy, 1 mid‐urethral sling

Interventions

Inclusion: stage 2 or greater cystocele

Exclusion: anterior not the leading prolapse

Concomitant surgery allowed

Stage 2 or greater uterine prolapse hysterectomy or sacrospinous ligament fixation (SSF)

SUI mid‐urethral sling

Outcomes

A, median 50; B, median 100

Blood loss > 500 mL: A 1, B 1

UDI: A vs B at baseline

Discomfort: 27 (24), 27 (23)

Overactive bladder: 34 (30), 41 (33)

Obstructive micturition: 28 (32), 19 (20)

Prolapse: 56 (30), 58 (35)

Incontinence: 23 (24), 19 (20)

UDI: A vs B at 1 year

Discomfort: 13 (19), 8 (12)

Overactive bladder: 16 (25), 15 (23)

Obstructive micturition: 15 (23), 11 (19)

Prolapse: 12 (22), 1 (4)

Incontinence: 18 (29), 16 (23)

B mesh erosion: 9/48

B surgery mesh exposure: 4/48

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not stated

Allocation concealment (selection bias)

Unclear risk

Not stated

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not stated

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not stated

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Not clear

Selective reporting (reporting bias)

Low risk

Significant outcome data

Other bias

Unclear risk

No statement

Turgal 2013

Methods

Parallel‐group RCT

Participants

Inclusion criteria: grade 2 or greater cystocele

Exclusion: urinary incontinence, prior gynaecological surgery, concomitant rectocele or enterocele, recurrent cystocele

Interventions

Polypropylene mesh (00000.3, Sofradim, Parieten) (20 women) vs AC (20 women)

Outcomes

Assessed at 6 weeks, 6 months, 1 year

Reported the following review outcomes at 1 year

  1. Awareness of prolapse (bulging): 5/20 vs 1/20

  2. Repeat prolapse (> stage 1 on examination): 1/20 vs 5/20

  3. Mesh erosion: n = 3

  4. Surgery for mesh erosion: n = 3

  5. Operating time: 44 ± 5, 21 ± 2

  6. De novo urinary incontinence: 0/20 vs 2/20

  7. Days in hospital: reported means but not SDs

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Allocated by computer programme"

Allocation concealment (selection bias)

Unclear risk

Method not described

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Blinding not mentioned

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Blinding not mentioned

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All 40/40 randomised women were included in the analysis.

Selective reporting (reporting bias)

Low risk

Reports main review outcomes

Other bias

Low risk

Reports "no conflict of interest". No other potential bias identified

Vollebregt 2011

Methods

Mutli‐centre RCT

Randomisation was computerised, and stratification was performed for the presence of uterine descent ≥ 2. No blinding to group assignment was performed.

Allocation concealment NS

Power 80 to detect 25% difference between groups with 5% type 1 error from sample size of 50 in each group

Participants

Inclusion: ≥ stage 2 cystocele

Exclusions: history of urogynaecological surgery for pelvic organ prolapse or incontinence, cancer or COPD, concomitant urinary stress incontinence with an indication for surgical correction, recurrent lower urinary tract infection (> 3 culture‐proven infections/y), maximum bladder capacity < 300 mL, indication for hysterectomy, childbearing potential and inadequate birth control measures

Randomised: A 64, B 61

Withdrawals before surgery: A 2, B 2

12 months: A 51, B 53

Interventions

A: AC; B: trocar‐guided transobturator synthetic mesh (AVULTA)

Outcomes

Assessed at 6 months and 1 year

Reported the following review outcomes at 1 year

  1. Awareness of prolapse (feeling a vaginal bulge): 9% in each group

  2. Repeat surgery for prolapse

  3. Recurrent prolapse (cystocele grade 2 or greater)

  4. Mesh exposure

  5. Surgery for mesh exposure

  6. Sexual function: de novo dyspareunia

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated

Allocation concealment (selection bias)

Low risk

Research nurse from online list

Blinding of participants and personnel (performance bias)
All outcomes

High risk

No

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Reviewers blinded by strapping of thighs before review

Incomplete outcome data (attrition bias)
All outcomes

Low risk

AC 55/56, mesh 55/58 ‐ 1 year

Selective reporting (reporting bias)

Low risk

Significant outcome data

Other bias

Low risk

No funding and no COI

Weber 2001

Methods

RCT with computer‐generated random number tables. Sealed envelopes concealed assignment. Investigators compared 3 surgical techniques
3 arms, 1 centre
Length of follow‐up: A + B + C, 23.3 months

Participants

83 women
Inclusion: all women undergoing cystocele repair
Exclusion: continence surgery (i.e. colposuspension or sling)
114 randomised
5 withdrawals
26 lost to follow‐up (A 2, B 15, C 9), leaving 83 in the trial

Interventions

A (33): anterior repair: midline plication without tension, 0 PDS
B (24): ultra‐lateral: dissection to pubic rami laterally, plication paravaginal with tension, 0 PDS interrupted
C (26): anterior repair plus mesh: standard plication midline Vicryl mesh overlay, Vicryl sutures

Outcomes

Assessed at 6 months, 1 year and 2 years

Reported the following review outcomes at median follow‐up 23 months (range 4.5 to 44.4 months)

  1. Awareness of prolapse (reported symptom severity on visual analogue scale but no comparative data)

  2. Recurrent prolapse (grade 2 or greater prolapse at point Aa or Ba, or worse than preoperative staging)

  3. Death

  4. Mesh erosion

Notes

Number and level of surgeons unknown
Adequate power
Non‐standardised concomitant surgery
Intention to treat: yes
No CONSORT
No stratification
Significant disparity in total numbers in Table 1, and actual numbers with prolapse reported
Except for point Aa POPQ, no individual outcome data reported for the 3 groups

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated

Allocation concealment (selection bias)

Low risk

Sealed opaque envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not stated

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not stated

Incomplete outcome data (attrition bias)
All outcomes

High risk

2‐Year review: AC 33/37 (89%); ultra‐lateral AC 24/39 (62%); Vicryl mesh 28/36 (78%) ‐ high risk due to disparity between groups

Selective reporting (reporting bias)

Low risk

Significant outcome data

Other bias

Unclear risk

NS

Withagen 2011

Methods

Multi‐centre randomised controlled trial

13 centres, 22 surgeons

Randomisation list computer generated for each of 13 centres. Allocation concealment was not discussed, and participants, surgeon and assessor (surgeon) were not blinded.

Surgeons underwent specific Prolift mesh training.

Full‐power calculation was completed.

Participants

Randomised: GP A 99, Gp B 95

1‐Year examination: A 84, B 83

Inclusion criteria: recurrent stage 2 or higher anterior and/or posterior wall prolapse

Exclusion criteria: pregnancy, future pregnancy, prior vaginal mesh repair, compromised immune system or any other condition that would compromise healing, previous pelvic irradiation or cancer, blood coagulation disorders, renal failure, upper urinary tract obstruction, renal failure and upper urinary tract obstruction, presence of large ovarian cysts or myomas

Interventions

Gp A: Conventional surgery was performed at the discretion of the surgeon, although absorbable sutures were specified and hysterectomies permitted

Gp B: standardised and structured in the tension‐free vaginal mesh; performed as described by Fatton (Fatton 2007) previously, and no hysterectomies performed nor T incisions allowed

Outcomes

Assessed at 6 months and at 1 year

Reported the following review outcomes at 1 year

  1. Repeat prolapse surgery

  2. Repeat surgery for prolapse, SUI or mesh exposure

  3. Mesh exposure

  4. Bladder injury (perforation)

  5. Surgery for mesh exposure

  6. POPQ assessment of prolapse: points Ba, Bp, C (reported median and range)

  7. Bladder function: de novo SUI

  8. Sexual function: de novo dyspareunia, PISQ‐12 (Milani 2011 reported mean and SD)

  9. Quality of life: PGI‐I questionnaire: rate of "much or very much better" (and other questionnaires)

Duration of surgery: reported median and range

Definition of success is unorthodox and different in Methods (≥ grade 2 prolapse in the treated site) and Results sections (≥ grade 2 POP in treated compartment or subsequent prolapse surgery). Furthermore, definition of treated compartment varies in each group. A includes all surgical sites; B excludes sites at which mesh was not utilised.

Notes

Study authors concluded that at 12 months, anatomical failure was less in Gp B (Prolift mesh) as compared with Gp A. These findings were overshadowed by the fact that the 2 groups were significantly different before intervention in terms of important findings. Lack of allocation concealment in the randomisation process, variability in and unorthodox definitions of success, non‐blinded surgeons reviewing their own surgery ‐ significant limitations of the manuscript

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated

Allocation concealment (selection bias)

High risk

Allocation concealment was not described. Preoperatively, group A was significantly different from the mesh group B, as demonstrated by a greater degree of prolapse at Ap, Bp and GH in Table 4, and a significantly greater number with ≥ stage 2 apical compartment prolapse among those in Table 1 undergoing prior apical surgery: 36% (16/45) in the non‐mesh group vs 18% (10/56) in the mesh group (P = 0.04, OR 2.54); finally, prior sacral colpopexy was 3 times as frequent in the mesh group.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Non‐blinded

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Non‐blinded reviewers; participant‐completed questionnaires

Incomplete outcome data (attrition bias)
All outcomes

Low risk

1 year ‐ AC 90/95, mesh 96/99

Selective reporting (reporting bias)

Low risk

Significant outcome data

Other bias

High risk

Funded university research: All authors reported financial support from Ethicon, the company manufacturing the product being evaluated by non‐blinded reviewers

AC = anterior colporrhaphy

AVWP = anterior vaginal wall prolapse

BW = Baden‐Walker

CI = confidence interval

COI = conflict of interest

COPD = chronic obstructive pulmonary disease

DM = diabetes mellitus

GH = genital hiatus

ICS = International Continence Society

IVS = intravaginal slingplasty

MUCP = maximum urethral catheter pressure

MUS = Mid‐urethral sling

NS = Not stated

OAB = overactive bladder

OR = odds ratio

OT = Operating time

PC = personal computer

PDS = absorbable polydioxanone surgical suture (PDS)

PFDI = Pelvic Floor Distress Inventory

PFIQ = Pelvic Floor Impact Questionnaire

PGI‐I = Patient Global Impression of Improvement

PISQ = Prolapse and Incontinence Sexual Questionnaire

POP = pelvic organ prolapse

POPQ = Pelvic Organ Prolapse Quantification (according to ICS)

PQOL = Prolapse Quality of Life Questionnaire

RCT = randomised controlled trial

SD = standard deviation

SIS = Small intestine submucosa

SS = statistically significant

SSF = sacrospinous (ligament) fixation

SUI = stress urinary incontinence (symptom diagnosis)

TCR = tension‐free cystocele repair

TVT = tension‐free vaginal tape

UDI = Urogenital Distress Inventory

UI = urinary incontinence

USI = urinary stress incontinence

UTI = urinary tract infection

VAS = visual analogue scale

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Heinonen 2011

Heinonen and Nieminen evaluated outcomes of anterior vaginal wall mesh augmentation with concomitant sacrospinous ligament fixation (SSLF) (n = 14) or with concomitant posterior intravaginal slingplasty (IVS) (n = 8) for uterovaginal or vaginal vault prolapse. On the basis of a predetermined decision that papers with fewer than 20 individuals in each treatment group would not be included in the review, we excluded the manuscript.

Kringel 2010

Kringel and colleagues compared interventions in a 3‐arm RCT (indwelling urinary catheter for 24 hours or 96 hours or suprapubic catheter for 96 hours) after an anterior colporrhaphy. Study authors concluded that optimal removal of an indwelling urinary catheter took place after 24 hours. We excluded this study from this review and will review catheter issues only at the time of prolapse surgery as a separate subgroup analysis within the surgical management of pelvic organ prolapse.

Tincello 2009

Tincello and associates reported a pilot randomised patient preference study that compared colposuspension or TVT for urinary incontinence at the time of anterior repair for prolapse. Although 31 women were recruited, only 4 (2 in each arm) were randomised. On the basis of a predetermined decision that papers with fewer than 20 individuals in each treatment group would not be included in the review, we excluded this manuscript.

Van Der Steen 2011

In a prospective randomised controlled trial, Van Der Steen compared 1‐day and 3‐day suprapubic catheters in women undergoing anterior colporrhaphy to determine the optimal duration of catheterisation. A total of 179 participants were randomly allocated to the 2 groups. We excluded this study from this review and will review catheter issues only at the time of prolapse surgery as a separate subgroup analysis within the surgical management of pelvic organ prolapse.

Weemhoff 2011

Weemhoff and colleagues compared the numbers of temporary catheter replacements and urinary tract infections after indwelling catheterisation for 2 vs 5 days after an anterior colporrhaphy. A total of 246 participants were randomly assigned to 2 or 5 days of indwelling catheterisation. We excluded this study from this review and will review catheter issues only at the time of prolapse surgery as a separate subgroup analysis within the surgical management of pelvic organ prolapse.

IVS = intravaginal slingplasty.

RCT = randomised controlled trial.

SSLF = sacrospinous ligament fixation.

TVT = tension‐free vaginal tape.

Characteristics of ongoing studies [ordered by study ID]

ACTRN12616000159459

Trial name or title

Anterior Pelvic Organ Prolapse Surgery: A randomised controlled trial of Xenform anterior repair versus anterior colporrhaphy

Methods

Patients will be recruited directly by participating surgeons. Randomisation will occur prior to surgery, with a central office co‐ordinating block randomisation with sealed envelopes

Participants

Women of age greater than 40 years, who are symptomatic anterior POP at or beyond hymen (point Ba greater than or equal to 0) AND have a desire for surgery

Interventions

Xenform anterior repair versus anterior colporrhaphy.

Outcomes

Primary

  1. Success defined as meeting all three criteria in a composite outcome at one year: 1.Point Ba less than or equal to 0 (POP‐Q) AND 2.A response of 0 or 1 to the question “Do you usually have a bulge or something falling out that you can see of feel in your vaginal area?” (Question 3 of the Pelvic Floor Distress Inventory‐Short Form 20 (PFDI‐20) AND 3.No reoperation for anterior vaginal wall prolapse; at one year post operative

Secondary

  1. Most distal position of upper anterior vaginal relative to hymen (Point Ba using POP‐Q method); at one year post operative

  2. Response to the question “Do you usually have a bulge or something falling out that you can see of feel in your vaginal area?” (Question 3 of the Pelvic Floor Distress Inventory‐Short Form 20); at one year post operative

  3. Quality of Life as assessed by total score of Pelvic Floor Distress Inventory‐Short Form 20; at one year post operative

  4. Postoperative complications such as bowel injury, bladder injury, estimated blood loss > 500mL, intra‐operative laparotomy, unplanned return to theatre; intraoperatively to hospital discharge

  5. Urinary tract infection, urinary retention treated with catheter, vaginal wound bleeding, vaginal epithelium separation or ulcer, vaginal graft exposure, pelvic pain, surgery for prolapse recurrence; hospital discharge to 2 months and 2 months to one year

Starting date

Anticipated date of first participant enrolment: 11 February 2016

Contact information

PI: Dr Todd Ladanchuk, King Edward Memorial Hospital

374 Bagot Road, Subiaco, Western Australia 6008

+61(8)93402222; [email protected]

Notes

Cortesse 2010

Trial name or title

ATHENA

Methods

RCT

Participants

Women with occult UI

Interventions

POP + SUI surgery vs POP surgery alone

Outcomes

Starting date

Contact information

Notes

Glazener 2009

Trial name or title

PROSPECT (PROlapse Surgery: Pragmatic Evaluaiton and Randomised Controlled Trials)

Methods

RCT

Participants

Women having prolapse surgery

Interventions

Anterior and posterior repair (colporrhaphy) with or without non‐absorbable or biological mesh inlay, or mesh kit

Outcomes

Prolapse symptoms (POP‐SS), prolapse stage (POP‐Q), economic outcomes

Starting date

01‐09‐2009

Contact information

[email protected]

Notes

HTA‐funded study in UK

Lucot 2015

Trial name or title

Prosthetic Pelvic Organ Prolapse Repair (Prospere)

Methods

RCT

Participants

Cystocele

Interventions

Lap sacral colpopexy vs vaginal mesh procedure unspecified

Outcomes

Starting date

2012

Contact information

http://clinicaltrials.gov/show/NCT01637441

Notes

Study has been completed but outcomes relevant to this review have not yet been reported

NCT00955448

Trial name or title

Trial of Small Intestine Submucosa (SIS) Mesh for Anterior Repair

Methods

RCT

Participants

Anterior prolapse

Interventions

Anterior repair vs SIS biograft (Cook)

Outcomes

Starting date

2009

Contact information

http://clinicaltrials.gov/show/NCT00955448

Notes

Study completed, but unable to identify publication

NCT01497171

Trial name or title

The Elegant Trial: Elevate Transvaginal Mesh Versus Anterior Colporrhaphy

Methods

RCT

Participants

Anterior prolapse

Interventions

Anterior repair vs elevate (AMS) anterior repair

Outcomes

Starting date

2011

Contact information

http://clinicaltrials.gov/show/NCT01497171

Notes

Study terminated owing to funding termination

Verleyen 2004

Trial name or title

Porcine Dermis vs Vicryl Plug in Raz Cystocele Repair

Methods

Participants

79 women (76 with concomitant prolapse)

Interventions

RCT, porcine dermis vs Vicryl

Outcomes

UDI, IIQ, urinary urgency, recurrent cystocele

Starting date

2003?

Contact information

Dr P Verleyen, University Hospitals, Gassthuisberg

Notes

AMS = American Medical Systems

HTA = Health Technology Assessment

IIQ = impact of urinary incontinence on activities, roles, and emotional states

POP = pelvic organ prolapse

POP‐Q = prolapse stage

POP‐SS = prolapse symptoms

RCT = randomised controlled trial

SIS = small intestine submucosa

SUI = stress urinary incontinence

TVT = tension‐free vaginal tape

UDI = Urinary Distress Inventory

UI = urinary infection

Data and analyses

Open in table viewer
Comparison 1. Native tissue versus biological graft

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Awareness of prolapse Show forest plot

5

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Analysis 1.1

Comparison 1 Native tissue versus biological graft, Outcome 1 Awareness of prolapse.

Comparison 1 Native tissue versus biological graft, Outcome 1 Awareness of prolapse.

1.1 Anterior repair vs any biological graft

5

552

Risk Ratio (M‐H, Random, 95% CI)

0.98 [0.52, 1.82]

1.2 Anterior repair vs fascial plication with porcine dermis graft

3

384

Risk Ratio (M‐H, Random, 95% CI)

0.66 [0.21, 2.10]

2 Repeat surgery Show forest plot

7

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 1.2

Comparison 1 Native tissue versus biological graft, Outcome 2 Repeat surgery.

Comparison 1 Native tissue versus biological graft, Outcome 2 Repeat surgery.

2.1 Prolapse

7

650

Risk Ratio (M‐H, Fixed, 95% CI)

1.02 [0.53, 1.97]

3 Recurrent anterior compartment prolapse Show forest plot

8

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 1.3

Comparison 1 Native tissue versus biological graft, Outcome 3 Recurrent anterior compartment prolapse.

Comparison 1 Native tissue versus biological graft, Outcome 3 Recurrent anterior compartment prolapse.

3.1 Anterior repair vs any biological graft

8

701

Risk Ratio (M‐H, Fixed, 95% CI)

1.32 [1.06, 1.65]

3.2 Anterior repair vs fascial plication with porcine dermis graft

4

392

Risk Ratio (M‐H, Fixed, 95% CI)

1.29 [0.98, 1.70]

4 Stress urinary incontinence Show forest plot

2

218

Risk Ratio (M‐H, Fixed, 95% CI)

1.44 [0.79, 2.64]

Analysis 1.4

Comparison 1 Native tissue versus biological graft, Outcome 4 Stress urinary incontinence.

Comparison 1 Native tissue versus biological graft, Outcome 4 Stress urinary incontinence.

5 POPQ assessment Show forest plot

1

56

Mean Difference (IV, Fixed, 95% CI)

0.5 [0.02, 0.98]

Analysis 1.5

Comparison 1 Native tissue versus biological graft, Outcome 5 POPQ assessment.

Comparison 1 Native tissue versus biological graft, Outcome 5 POPQ assessment.

5.1 Point Ba POPQ

1

56

Mean Difference (IV, Fixed, 95% CI)

0.5 [0.02, 0.98]

6 Urge incontinence Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 1.6

Comparison 1 Native tissue versus biological graft, Outcome 6 Urge incontinence.

Comparison 1 Native tissue versus biological graft, Outcome 6 Urge incontinence.

7 Voiding dysfunction Show forest plot

2

155

Risk Ratio (M‐H, Fixed, 95% CI)

1.13 [0.71, 1.80]

Analysis 1.7

Comparison 1 Native tissue versus biological graft, Outcome 7 Voiding dysfunction.

Comparison 1 Native tissue versus biological graft, Outcome 7 Voiding dysfunction.

8 Dyspareunia Show forest plot

2

151

Risk Ratio (M‐H, Fixed, 95% CI)

0.87 [0.39, 1.93]

Analysis 1.8

Comparison 1 Native tissue versus biological graft, Outcome 8 Dyspareunia.

Comparison 1 Native tissue versus biological graft, Outcome 8 Dyspareunia.

9 Quality of life PROLAPSE Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

Analysis 1.9

Comparison 1 Native tissue versus biological graft, Outcome 9 Quality of life PROLAPSE.

Comparison 1 Native tissue versus biological graft, Outcome 9 Quality of life PROLAPSE.

9.1 Questionnaire (P‐QOL) 0‐100

1

56

Mean Difference (IV, Fixed, 95% CI)

‐1.0 [‐6.01, 4.01]

10 Operating time (minutes) Show forest plot

2

113

Mean Difference (IV, Fixed, 95% CI)

‐10.35 [‐14.45, ‐6.24]

Analysis 1.10

Comparison 1 Native tissue versus biological graft, Outcome 10 Operating time (minutes).

Comparison 1 Native tissue versus biological graft, Outcome 10 Operating time (minutes).

11 Hospital stay Show forest plot

1

201

Mean Difference (IV, Fixed, 95% CI)

0.30 [‐0.09, 0.69]

Analysis 1.11

Comparison 1 Native tissue versus biological graft, Outcome 11 Hospital stay.

Comparison 1 Native tissue versus biological graft, Outcome 11 Hospital stay.

Open in table viewer
Comparison 2. Native tissue versus polypropylene mesh

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Awareness of prolapse Show forest plot

9

1133

Risk Ratio (M‐H, Fixed, 95% CI)

1.77 [1.37, 2.28]

Analysis 2.1

Comparison 2 Native tissue versus polypropylene mesh, Outcome 1 Awareness of prolapse.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 1 Awareness of prolapse.

2 Repeat surgery Show forest plot

13

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 2.2

Comparison 2 Native tissue versus polypropylene mesh, Outcome 2 Repeat surgery.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 2 Repeat surgery.

2.1 Prolapse

12

1629

Risk Ratio (M‐H, Fixed, 95% CI)

2.03 [1.15, 3.58]

2.2 Reoperation for stress urinary incontinence (1‐3 years)

5

881

Risk Ratio (M‐H, Fixed, 95% CI)

1.19 [0.60, 2.36]

2.3 Surgery for prolapse, SUI or mesh exposure

12

1527

Risk Ratio (M‐H, Fixed, 95% CI)

0.59 [0.41, 0.83]

3 Recurrent anterior compartment prolapse Show forest plot

16

1976

Risk Ratio (M‐H, Fixed, 95% CI)

3.01 [2.52, 3.60]

Analysis 2.3

Comparison 2 Native tissue versus polypropylene mesh, Outcome 3 Recurrent anterior compartment prolapse.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 3 Recurrent anterior compartment prolapse.

3.1 Permanent mesh vs native tissue repair

16

1976

Risk Ratio (M‐H, Fixed, 95% CI)

3.01 [2.52, 3.60]

4 Bladder injury Show forest plot

6

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 2.4

Comparison 2 Native tissue versus polypropylene mesh, Outcome 4 Bladder injury.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 4 Bladder injury.

4.1 Anterior repair vs any transvaginal polypropylene mesh

6

871

Risk Ratio (M‐H, Fixed, 95% CI)

0.21 [0.06, 0.82]

5 Apical or posterior compartment prolapse Show forest plot

2

300

Risk Ratio (M‐H, Fixed, 95% CI)

0.54 [0.30, 0.99]

Analysis 2.5

Comparison 2 Native tissue versus polypropylene mesh, Outcome 5 Apical or posterior compartment prolapse.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 5 Apical or posterior compartment prolapse.

6 POPQ assessment Show forest plot

6

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 2.6

Comparison 2 Native tissue versus polypropylene mesh, Outcome 6 POPQ assessment.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 6 POPQ assessment.

6.1 Point Ba POPQ

6

568

Mean Difference (IV, Random, 95% CI)

0.55 [0.30, 0.80]

6.2 Point Bp POPQ

3

276

Mean Difference (IV, Random, 95% CI)

‐0.43 [‐0.92, 0.06]

6.3 Point C POPQ

4

369

Mean Difference (IV, Random, 95% CI)

0.27 [‐0.47, 1.01]

6.4 Total vaginal length

3

366

Mean Difference (IV, Random, 95% CI)

‐0.18 [‐0.78, 0.43]

7 Stress urinary incontinence (de novo) Show forest plot

6

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 2.7

Comparison 2 Native tissue versus polypropylene mesh, Outcome 7 Stress urinary incontinence (de novo).

Comparison 2 Native tissue versus polypropylene mesh, Outcome 7 Stress urinary incontinence (de novo).

7.1 Polypropylene mesh vs native tissue (de novo)

6

957

Risk Ratio (M‐H, Fixed, 95% CI)

0.67 [0.44, 1.01]

8 De novo dyspareunia Show forest plot

8

583

Risk Ratio (M‐H, Fixed, 95% CI)

0.54 [0.27, 1.06]

Analysis 2.8

Comparison 2 Native tissue versus polypropylene mesh, Outcome 8 De novo dyspareunia.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 8 De novo dyspareunia.

9 Voiding dysfunction Show forest plot

3

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 2.9

Comparison 2 Native tissue versus polypropylene mesh, Outcome 9 Voiding dysfunction.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 9 Voiding dysfunction.

9.1 Anterior repair vs polypropylene mesh (persistent)

3

277

Risk Ratio (M‐H, Fixed, 95% CI)

1.22 [0.33, 4.47]

10 Urge incontinence Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 2.10

Comparison 2 Native tissue versus polypropylene mesh, Outcome 10 Urge incontinence.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 10 Urge incontinence.

10.1 Anterior repair vs transvaginal permanent mesh

2

198

Risk Ratio (M‐H, Fixed, 95% CI)

2.20 [0.33, 14.68]

11 Dyspareunia Show forest plot

8

1096

Risk Ratio (M‐H, Fixed, 95% CI)

1.06 [0.59, 1.90]

Analysis 2.11

Comparison 2 Native tissue versus polypropylene mesh, Outcome 11 Dyspareunia.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 11 Dyspareunia.

11.1 Anterior repair vs any transvaginal polypropylene mesh

8

1096

Risk Ratio (M‐H, Fixed, 95% CI)

1.06 [0.59, 1.90]

12 Quality of life PROLAPSE Show forest plot

8

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 2.12

Comparison 2 Native tissue versus polypropylene mesh, Outcome 12 Quality of life PROLAPSE.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 12 Quality of life PROLAPSE.

12.1 Questionnaire (PQOL) 0‐100

2

164

Mean Difference (IV, Random, 95% CI)

1.09 [‐1.19, 3.37]

12.2 Pelvic Floor Impact Questionnaire (PFIQ‐7) 0‐400

3

290

Mean Difference (IV, Random, 95% CI)

1.90 [‐7.78, 11.59]

12.3 Pelvic floor distress inventory (PFD1‐20) 0‐300

3

294

Mean Difference (IV, Random, 95% CI)

3.89 [‐12.82, 20.61]

12.4 Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ)

4

741

Mean Difference (IV, Random, 95% CI)

‐0.06 [‐0.76, 0.64]

12.5 ICIQ‐QOL

1

92

Mean Difference (IV, Random, 95% CI)

0.70 [‐0.15, 1.55]

12.6 ICIQ‐VS

1

92

Mean Difference (IV, Random, 95% CI)

1.10 [‐0.88, 3.08]

13 Hospital stay (days) Show forest plot

5

707

Mean Difference (IV, Random, 95% CI)

0.08 [‐0.17, 0.33]

Analysis 2.13

Comparison 2 Native tissue versus polypropylene mesh, Outcome 13 Hospital stay (days).

Comparison 2 Native tissue versus polypropylene mesh, Outcome 13 Hospital stay (days).

14 Operating time (minutes) Show forest plot

7

1099

Mean Difference (IV, Random, 95% CI)

‐17.89 [‐25.81, ‐9.98]

Analysis 2.14

Comparison 2 Native tissue versus polypropylene mesh, Outcome 14 Operating time (minutes).

Comparison 2 Native tissue versus polypropylene mesh, Outcome 14 Operating time (minutes).

15 Transfusion Show forest plot

4

486

Risk Ratio (M‐H, Fixed, 95% CI)

0.42 [0.24, 0.76]

Analysis 2.15

Comparison 2 Native tissue versus polypropylene mesh, Outcome 15 Transfusion.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 15 Transfusion.

Open in table viewer
Comparison 3. Subgroup analysis: native tissue versus polypropylene mesh available for use

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Awareness of prolapse Show forest plot

5

518

Risk Ratio (M‐H, Fixed, 95% CI)

2.12 [1.35, 3.35]

Analysis 3.1

Comparison 3 Subgroup analysis: native tissue versus polypropylene mesh available for use, Outcome 1 Awareness of prolapse.

Comparison 3 Subgroup analysis: native tissue versus polypropylene mesh available for use, Outcome 1 Awareness of prolapse.

2 Repeat surgery Show forest plot

7

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 3.2

Comparison 3 Subgroup analysis: native tissue versus polypropylene mesh available for use, Outcome 2 Repeat surgery.

Comparison 3 Subgroup analysis: native tissue versus polypropylene mesh available for use, Outcome 2 Repeat surgery.

2.1 Prolapse

7

815

Risk Ratio (M‐H, Fixed, 95% CI)

2.34 [1.20, 4.59]

2.2 Repeat surgery for stress urinary incontinence (1‐3 years)

2

333

Risk Ratio (M‐H, Fixed, 95% CI)

1.56 [0.60, 4.10]

2.3 Repeat surgery for prolapse, SUI or mesh exposure

6

648

Risk Ratio (M‐H, Fixed, 95% CI)

0.82 [0.55, 1.24]

3 Recurrent anterior compartment prolapse Show forest plot

8

970

Risk Ratio (M‐H, Fixed, 95% CI)

2.35 [1.83, 3.01]

Analysis 3.3

Comparison 3 Subgroup analysis: native tissue versus polypropylene mesh available for use, Outcome 3 Recurrent anterior compartment prolapse.

Comparison 3 Subgroup analysis: native tissue versus polypropylene mesh available for use, Outcome 3 Recurrent anterior compartment prolapse.

3.1 Permanent mesh vs native tissue repair

8

970

Risk Ratio (M‐H, Fixed, 95% CI)

2.35 [1.83, 3.01]

Open in table viewer
Comparison 4. Native tissue versus absorbable mesh

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Awareness of prolapse (2‐year review) Show forest plot

1

54

Risk Ratio (M‐H, Fixed, 95% CI)

0.95 [0.70, 1.31]

Analysis 4.1

Comparison 4 Native tissue versus absorbable mesh, Outcome 1 Awareness of prolapse (2‐year review).

Comparison 4 Native tissue versus absorbable mesh, Outcome 1 Awareness of prolapse (2‐year review).

2 Repeat surgery for prolapse (2 years) Show forest plot

1

66

Risk Ratio (M‐H, Fixed, 95% CI)

2.13 [0.42, 10.82]

Analysis 4.2

Comparison 4 Native tissue versus absorbable mesh, Outcome 2 Repeat surgery for prolapse (2 years).

Comparison 4 Native tissue versus absorbable mesh, Outcome 2 Repeat surgery for prolapse (2 years).

3 Anterior compartment prolapse (3 months‐2 years) Show forest plot

3

268

Risk Ratio (M‐H, Fixed, 95% CI)

1.50 [1.09, 2.06]

Analysis 4.3

Comparison 4 Native tissue versus absorbable mesh, Outcome 3 Anterior compartment prolapse (3 months‐2 years).

Comparison 4 Native tissue versus absorbable mesh, Outcome 3 Anterior compartment prolapse (3 months‐2 years).

4 Death Show forest plot

2

175

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Analysis 4.4

Comparison 4 Native tissue versus absorbable mesh, Outcome 4 Death.

Comparison 4 Native tissue versus absorbable mesh, Outcome 4 Death.

5 Posterior compartment prolapse Show forest plot

1

132

Risk Ratio (M‐H, Fixed, 95% CI)

0.88 [0.31, 2.49]

Analysis 4.5

Comparison 4 Native tissue versus absorbable mesh, Outcome 5 Posterior compartment prolapse.

Comparison 4 Native tissue versus absorbable mesh, Outcome 5 Posterior compartment prolapse.

6 Stress urinary incontinence Show forest plot

1

49

Risk Ratio (M‐H, Fixed, 95% CI)

0.72 [0.50, 1.05]

Analysis 4.6

Comparison 4 Native tissue versus absorbable mesh, Outcome 6 Stress urinary incontinence.

Comparison 4 Native tissue versus absorbable mesh, Outcome 6 Stress urinary incontinence.

7 Quality of life Show forest plot

1

54

Mean Difference (IV, Fixed, 95% CI)

0.0 [‐2.82, 2.82]

Analysis 4.7

Comparison 4 Native tissue versus absorbable mesh, Outcome 7 Quality of life.

Comparison 4 Native tissue versus absorbable mesh, Outcome 7 Quality of life.

7.1 VA QOL

1

54

Mean Difference (IV, Fixed, 95% CI)

0.0 [‐2.82, 2.82]

Open in table viewer
Comparison 5. Mesh versus biological graft

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Awareness of prolapse Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 5.1

Comparison 5 Mesh versus biological graft, Outcome 1 Awareness of prolapse.

Comparison 5 Mesh versus biological graft, Outcome 1 Awareness of prolapse.

1.1 Polypropylene mesh (Gynemesh) vs porcine dermis

1

190

Risk Ratio (M‐H, Fixed, 95% CI)

0.98 [0.20, 4.73]

2 Repeat surgery Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 5.2

Comparison 5 Mesh versus biological graft, Outcome 2 Repeat surgery.

Comparison 5 Mesh versus biological graft, Outcome 2 Repeat surgery.

2.1 Prolapse

2

315

Risk Ratio (M‐H, Fixed, 95% CI)

3.05 [0.87, 10.73]

3 Recurrent anterior wall compartment prolapse (stage 2 or greater) Show forest plot

2

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Analysis 5.3

Comparison 5 Mesh versus biological graft, Outcome 3 Recurrent anterior wall compartment prolapse (stage 2 or greater).

Comparison 5 Mesh versus biological graft, Outcome 3 Recurrent anterior wall compartment prolapse (stage 2 or greater).

3.1 Permanent mesh vs biological graft

1

190

Risk Ratio (M‐H, Random, 95% CI)

0.64 [0.43, 0.96]

3.2 Absorbable mesh vs biological graft

1

125

Risk Ratio (M‐H, Random, 95% CI)

3.22 [1.38, 7.52]

4 Mesh exposure Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 5.4

Comparison 5 Mesh versus biological graft, Outcome 4 Mesh exposure.

Comparison 5 Mesh versus biological graft, Outcome 4 Mesh exposure.

4.1 Polypropylene mesh vs porcine dermis

2

241

Risk Ratio (M‐H, Fixed, 95% CI)

0.09 [0.01, 0.69]

5 Stress urinary incontinence (de novo) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 5.5

Comparison 5 Mesh versus biological graft, Outcome 5 Stress urinary incontinence (de novo).

Comparison 5 Mesh versus biological graft, Outcome 5 Stress urinary incontinence (de novo).

5.1 Armed polypropylene mesh (Gynemesh) vs Pelvicol

1

190

Risk Ratio (M‐H, Fixed, 95% CI)

1.96 [0.18, 21.23]

6 Urgency, detrusor overactivity or overactive bladder (de novo) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 5.6

Comparison 5 Mesh versus biological graft, Outcome 6 Urgency, detrusor overactivity or overactive bladder (de novo).

Comparison 5 Mesh versus biological graft, Outcome 6 Urgency, detrusor overactivity or overactive bladder (de novo).

6.1 Armed polypropylene mesh (Gynemesh) vs Pelvicol

1

37

Risk Ratio (M‐H, Fixed, 95% CI)

0.47 [0.05, 4.78]

7 Dyspareunia (persistent) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 5.7

Comparison 5 Mesh versus biological graft, Outcome 7 Dyspareunia (persistent).

Comparison 5 Mesh versus biological graft, Outcome 7 Dyspareunia (persistent).

7.1 Armed polypropylene mesh (Gynemesh) vs Pelvicol

1

190

Risk Ratio (M‐H, Fixed, 95% CI)

0.82 [0.37, 1.80]

Open in table viewer
Comparison 6. Vaginal repair versus abdominal repair

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Recurrent anterior wall prolapse Show forest plot

2

118

Risk Ratio (M‐H, Random, 95% CI)

0.31 [0.03, 3.46]

Analysis 6.1

Comparison 6 Vaginal repair versus abdominal repair, Outcome 1 Recurrent anterior wall prolapse.

Comparison 6 Vaginal repair versus abdominal repair, Outcome 1 Recurrent anterior wall prolapse.

2 Injury Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 6.2

Comparison 6 Vaginal repair versus abdominal repair, Outcome 2 Injury.

Comparison 6 Vaginal repair versus abdominal repair, Outcome 2 Injury.

2.1 Bladder

1

67

Risk Ratio (M‐H, Fixed, 95% CI)

0.97 [0.06, 14.88]

3 Posterior compartment prolapse Show forest plot

2

118

Risk Ratio (M‐H, Random, 95% CI)

1.81 [0.17, 19.65]

Analysis 6.3

Comparison 6 Vaginal repair versus abdominal repair, Outcome 3 Posterior compartment prolapse.

Comparison 6 Vaginal repair versus abdominal repair, Outcome 3 Posterior compartment prolapse.

4 POPQ assessment Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

Analysis 6.4

Comparison 6 Vaginal repair versus abdominal repair, Outcome 4 POPQ assessment.

Comparison 6 Vaginal repair versus abdominal repair, Outcome 4 POPQ assessment.

4.1 Point Ba POPQ

1

50

Mean Difference (IV, Fixed, 95% CI)

0.90 [‐0.15, 1.95]

4.2 Total vaginal length

1

68

Mean Difference (IV, Fixed, 95% CI)

3.20 [2.58, 3.82]

5 Dyspareunia Show forest plot

2

97

Risk Ratio (M‐H, Fixed, 95% CI)

5.17 [1.63, 16.35]

Analysis 6.5

Comparison 6 Vaginal repair versus abdominal repair, Outcome 5 Dyspareunia.

Comparison 6 Vaginal repair versus abdominal repair, Outcome 5 Dyspareunia.

6 Quality of life PROLAPSE Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

Analysis 6.6

Comparison 6 Vaginal repair versus abdominal repair, Outcome 6 Quality of life PROLAPSE.

Comparison 6 Vaginal repair versus abdominal repair, Outcome 6 Quality of life PROLAPSE.

6.1 Pelvic floor impact questionnaire (PFIQ‐7) 0‐400

1

50

Mean Difference (IV, Fixed, 95% CI)

‐9.0 [‐52.11, 34.11]

6.2 Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ)

1

50

Mean Difference (IV, Fixed, 95% CI)

‐2.0 [‐6.24, 2.24]

7 Operating time (minutes) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

Analysis 6.7

Comparison 6 Vaginal repair versus abdominal repair, Outcome 7 Operating time (minutes).

Comparison 6 Vaginal repair versus abdominal repair, Outcome 7 Operating time (minutes).

8 Transfusion Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 6.8

Comparison 6 Vaginal repair versus abdominal repair, Outcome 8 Transfusion.

Comparison 6 Vaginal repair versus abdominal repair, Outcome 8 Transfusion.

Open in table viewer
Comparison 7. Native tissue repair versus graft repair for anterior and/or posterior prolapse

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Awareness of prolapse Show forest plot

3

406

Risk Ratio (M‐H, Random, 95% CI)

0.85 [0.36, 1.99]

Analysis 7.1

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 1 Awareness of prolapse.

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 1 Awareness of prolapse.

1.1 Anterior and/or posterior repair vs polypropylene mesh

2

280

Risk Ratio (M‐H, Random, 95% CI)

1.17 [0.70, 1.96]

1.2 Anterior and/or posterior repair vs porcine dermis (Pelvicol)

1

126

Risk Ratio (M‐H, Random, 95% CI)

0.22 [0.05, 0.96]

2 Repeat surgery prolapse Show forest plot

2

291

Risk Ratio (M‐H, Fixed, 95% CI)

6.86 [0.86, 54.99]

Analysis 7.2

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 2 Repeat surgery prolapse.

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 2 Repeat surgery prolapse.

2.1 Anterior and/or posterior repair vs polypropylene mesh

2

291

Risk Ratio (M‐H, Fixed, 95% CI)

6.86 [0.86, 54.99]

3 Recurrent anterior wall prolapse (stage 2 or greater) Show forest plot

3

492

Risk Ratio (M‐H, Fixed, 95% CI)

1.04 [0.77, 1.40]

Analysis 7.3

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 3 Recurrent anterior wall prolapse (stage 2 or greater).

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 3 Recurrent anterior wall prolapse (stage 2 or greater).

3.1 Anterior colporrhaphy vs polypropylene mesh

2

280

Risk Ratio (M‐H, Fixed, 95% CI)

1.18 [0.70, 1.97]

3.2 Anterior colporrhaphy vs biological graft

1

87

Risk Ratio (M‐H, Fixed, 95% CI)

0.92 [0.65, 1.30]

3.3 Anterior and/or posterior repair vs biological graft

1

125

Risk Ratio (M‐H, Fixed, 95% CI)

1.08 [0.33, 3.56]

4 Bladder injury Show forest plot

1

166

Risk Ratio (M‐H, Fixed, 95% CI)

0.20 [0.01, 4.01]

Analysis 7.4

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 4 Bladder injury.

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 4 Bladder injury.

5 Stress urinary incontinence (de novo) Show forest plot

1

105

Risk Ratio (M‐H, Fixed, 95% CI)

0.98 [0.34, 2.85]

Analysis 7.5

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 5 Stress urinary incontinence (de novo).

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 5 Stress urinary incontinence (de novo).

6 Dyspareunia (de novo and persistent) Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 7.6

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 6 Dyspareunia (de novo and persistent).

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 6 Dyspareunia (de novo and persistent).

6.1 Anterior repair vs polypropylene mesh (de novo)

2

188

Risk Ratio (M‐H, Fixed, 95% CI)

1.23 [0.64, 2.36]

6.2 Anterior repair vs polypropylene mesh (persistent)

1

122

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.70, 1.52]

7 Quality of life PROLAPSE Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

Analysis 7.7

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 7 Quality of life PROLAPSE.

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 7 Quality of life PROLAPSE.

7.1 Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ)

1

60

Mean Difference (IV, Fixed, 95% CI)

0.40 [‐2.74, 3.54]

PRISMA study flow diagram for 2016 review.
Figuras y tablas -
Figure 1

PRISMA study flow diagram for 2016 review.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 3

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Forest plot of comparison: 1 Native tissue versus biological graft, outcome: 1.1 Awareness of prolapse.
Figuras y tablas -
Figure 4

Forest plot of comparison: 1 Native tissue versus biological graft, outcome: 1.1 Awareness of prolapse.

Forest plot of comparison: 2 Native tissue versus polypropylene mesh, outcome: 2.1 Awareness of prolapse.
Figuras y tablas -
Figure 5

Forest plot of comparison: 2 Native tissue versus polypropylene mesh, outcome: 2.1 Awareness of prolapse.

Forest plot of comparison: 2 Native tissue versus polypropylene mesh, outcome: 2.3 Recurrent anterior compartment prolapse.
Figuras y tablas -
Figure 6

Forest plot of comparison: 2 Native tissue versus polypropylene mesh, outcome: 2.3 Recurrent anterior compartment prolapse.

Funnel plot of comparison: 2 Native tissue versus polypropylene mesh, outcome: 2.3 Recurrent anterior compartment prolapse.
Figuras y tablas -
Figure 7

Funnel plot of comparison: 2 Native tissue versus polypropylene mesh, outcome: 2.3 Recurrent anterior compartment prolapse.

Comparison 1 Native tissue versus biological graft, Outcome 1 Awareness of prolapse.
Figuras y tablas -
Analysis 1.1

Comparison 1 Native tissue versus biological graft, Outcome 1 Awareness of prolapse.

Comparison 1 Native tissue versus biological graft, Outcome 2 Repeat surgery.
Figuras y tablas -
Analysis 1.2

Comparison 1 Native tissue versus biological graft, Outcome 2 Repeat surgery.

Comparison 1 Native tissue versus biological graft, Outcome 3 Recurrent anterior compartment prolapse.
Figuras y tablas -
Analysis 1.3

Comparison 1 Native tissue versus biological graft, Outcome 3 Recurrent anterior compartment prolapse.

Comparison 1 Native tissue versus biological graft, Outcome 4 Stress urinary incontinence.
Figuras y tablas -
Analysis 1.4

Comparison 1 Native tissue versus biological graft, Outcome 4 Stress urinary incontinence.

Comparison 1 Native tissue versus biological graft, Outcome 5 POPQ assessment.
Figuras y tablas -
Analysis 1.5

Comparison 1 Native tissue versus biological graft, Outcome 5 POPQ assessment.

Comparison 1 Native tissue versus biological graft, Outcome 6 Urge incontinence.
Figuras y tablas -
Analysis 1.6

Comparison 1 Native tissue versus biological graft, Outcome 6 Urge incontinence.

Comparison 1 Native tissue versus biological graft, Outcome 7 Voiding dysfunction.
Figuras y tablas -
Analysis 1.7

Comparison 1 Native tissue versus biological graft, Outcome 7 Voiding dysfunction.

Comparison 1 Native tissue versus biological graft, Outcome 8 Dyspareunia.
Figuras y tablas -
Analysis 1.8

Comparison 1 Native tissue versus biological graft, Outcome 8 Dyspareunia.

Comparison 1 Native tissue versus biological graft, Outcome 9 Quality of life PROLAPSE.
Figuras y tablas -
Analysis 1.9

Comparison 1 Native tissue versus biological graft, Outcome 9 Quality of life PROLAPSE.

Comparison 1 Native tissue versus biological graft, Outcome 10 Operating time (minutes).
Figuras y tablas -
Analysis 1.10

Comparison 1 Native tissue versus biological graft, Outcome 10 Operating time (minutes).

Comparison 1 Native tissue versus biological graft, Outcome 11 Hospital stay.
Figuras y tablas -
Analysis 1.11

Comparison 1 Native tissue versus biological graft, Outcome 11 Hospital stay.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 1 Awareness of prolapse.
Figuras y tablas -
Analysis 2.1

Comparison 2 Native tissue versus polypropylene mesh, Outcome 1 Awareness of prolapse.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 2 Repeat surgery.
Figuras y tablas -
Analysis 2.2

Comparison 2 Native tissue versus polypropylene mesh, Outcome 2 Repeat surgery.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 3 Recurrent anterior compartment prolapse.
Figuras y tablas -
Analysis 2.3

Comparison 2 Native tissue versus polypropylene mesh, Outcome 3 Recurrent anterior compartment prolapse.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 4 Bladder injury.
Figuras y tablas -
Analysis 2.4

Comparison 2 Native tissue versus polypropylene mesh, Outcome 4 Bladder injury.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 5 Apical or posterior compartment prolapse.
Figuras y tablas -
Analysis 2.5

Comparison 2 Native tissue versus polypropylene mesh, Outcome 5 Apical or posterior compartment prolapse.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 6 POPQ assessment.
Figuras y tablas -
Analysis 2.6

Comparison 2 Native tissue versus polypropylene mesh, Outcome 6 POPQ assessment.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 7 Stress urinary incontinence (de novo).
Figuras y tablas -
Analysis 2.7

Comparison 2 Native tissue versus polypropylene mesh, Outcome 7 Stress urinary incontinence (de novo).

Comparison 2 Native tissue versus polypropylene mesh, Outcome 8 De novo dyspareunia.
Figuras y tablas -
Analysis 2.8

Comparison 2 Native tissue versus polypropylene mesh, Outcome 8 De novo dyspareunia.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 9 Voiding dysfunction.
Figuras y tablas -
Analysis 2.9

Comparison 2 Native tissue versus polypropylene mesh, Outcome 9 Voiding dysfunction.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 10 Urge incontinence.
Figuras y tablas -
Analysis 2.10

Comparison 2 Native tissue versus polypropylene mesh, Outcome 10 Urge incontinence.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 11 Dyspareunia.
Figuras y tablas -
Analysis 2.11

Comparison 2 Native tissue versus polypropylene mesh, Outcome 11 Dyspareunia.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 12 Quality of life PROLAPSE.
Figuras y tablas -
Analysis 2.12

Comparison 2 Native tissue versus polypropylene mesh, Outcome 12 Quality of life PROLAPSE.

Comparison 2 Native tissue versus polypropylene mesh, Outcome 13 Hospital stay (days).
Figuras y tablas -
Analysis 2.13

Comparison 2 Native tissue versus polypropylene mesh, Outcome 13 Hospital stay (days).

Comparison 2 Native tissue versus polypropylene mesh, Outcome 14 Operating time (minutes).
Figuras y tablas -
Analysis 2.14

Comparison 2 Native tissue versus polypropylene mesh, Outcome 14 Operating time (minutes).

Comparison 2 Native tissue versus polypropylene mesh, Outcome 15 Transfusion.
Figuras y tablas -
Analysis 2.15

Comparison 2 Native tissue versus polypropylene mesh, Outcome 15 Transfusion.

Comparison 3 Subgroup analysis: native tissue versus polypropylene mesh available for use, Outcome 1 Awareness of prolapse.
Figuras y tablas -
Analysis 3.1

Comparison 3 Subgroup analysis: native tissue versus polypropylene mesh available for use, Outcome 1 Awareness of prolapse.

Comparison 3 Subgroup analysis: native tissue versus polypropylene mesh available for use, Outcome 2 Repeat surgery.
Figuras y tablas -
Analysis 3.2

Comparison 3 Subgroup analysis: native tissue versus polypropylene mesh available for use, Outcome 2 Repeat surgery.

Comparison 3 Subgroup analysis: native tissue versus polypropylene mesh available for use, Outcome 3 Recurrent anterior compartment prolapse.
Figuras y tablas -
Analysis 3.3

Comparison 3 Subgroup analysis: native tissue versus polypropylene mesh available for use, Outcome 3 Recurrent anterior compartment prolapse.

Comparison 4 Native tissue versus absorbable mesh, Outcome 1 Awareness of prolapse (2‐year review).
Figuras y tablas -
Analysis 4.1

Comparison 4 Native tissue versus absorbable mesh, Outcome 1 Awareness of prolapse (2‐year review).

Comparison 4 Native tissue versus absorbable mesh, Outcome 2 Repeat surgery for prolapse (2 years).
Figuras y tablas -
Analysis 4.2

Comparison 4 Native tissue versus absorbable mesh, Outcome 2 Repeat surgery for prolapse (2 years).

Comparison 4 Native tissue versus absorbable mesh, Outcome 3 Anterior compartment prolapse (3 months‐2 years).
Figuras y tablas -
Analysis 4.3

Comparison 4 Native tissue versus absorbable mesh, Outcome 3 Anterior compartment prolapse (3 months‐2 years).

Comparison 4 Native tissue versus absorbable mesh, Outcome 4 Death.
Figuras y tablas -
Analysis 4.4

Comparison 4 Native tissue versus absorbable mesh, Outcome 4 Death.

Comparison 4 Native tissue versus absorbable mesh, Outcome 5 Posterior compartment prolapse.
Figuras y tablas -
Analysis 4.5

Comparison 4 Native tissue versus absorbable mesh, Outcome 5 Posterior compartment prolapse.

Comparison 4 Native tissue versus absorbable mesh, Outcome 6 Stress urinary incontinence.
Figuras y tablas -
Analysis 4.6

Comparison 4 Native tissue versus absorbable mesh, Outcome 6 Stress urinary incontinence.

Comparison 4 Native tissue versus absorbable mesh, Outcome 7 Quality of life.
Figuras y tablas -
Analysis 4.7

Comparison 4 Native tissue versus absorbable mesh, Outcome 7 Quality of life.

Comparison 5 Mesh versus biological graft, Outcome 1 Awareness of prolapse.
Figuras y tablas -
Analysis 5.1

Comparison 5 Mesh versus biological graft, Outcome 1 Awareness of prolapse.

Comparison 5 Mesh versus biological graft, Outcome 2 Repeat surgery.
Figuras y tablas -
Analysis 5.2

Comparison 5 Mesh versus biological graft, Outcome 2 Repeat surgery.

Comparison 5 Mesh versus biological graft, Outcome 3 Recurrent anterior wall compartment prolapse (stage 2 or greater).
Figuras y tablas -
Analysis 5.3

Comparison 5 Mesh versus biological graft, Outcome 3 Recurrent anterior wall compartment prolapse (stage 2 or greater).

Comparison 5 Mesh versus biological graft, Outcome 4 Mesh exposure.
Figuras y tablas -
Analysis 5.4

Comparison 5 Mesh versus biological graft, Outcome 4 Mesh exposure.

Comparison 5 Mesh versus biological graft, Outcome 5 Stress urinary incontinence (de novo).
Figuras y tablas -
Analysis 5.5

Comparison 5 Mesh versus biological graft, Outcome 5 Stress urinary incontinence (de novo).

Comparison 5 Mesh versus biological graft, Outcome 6 Urgency, detrusor overactivity or overactive bladder (de novo).
Figuras y tablas -
Analysis 5.6

Comparison 5 Mesh versus biological graft, Outcome 6 Urgency, detrusor overactivity or overactive bladder (de novo).

Comparison 5 Mesh versus biological graft, Outcome 7 Dyspareunia (persistent).
Figuras y tablas -
Analysis 5.7

Comparison 5 Mesh versus biological graft, Outcome 7 Dyspareunia (persistent).

Comparison 6 Vaginal repair versus abdominal repair, Outcome 1 Recurrent anterior wall prolapse.
Figuras y tablas -
Analysis 6.1

Comparison 6 Vaginal repair versus abdominal repair, Outcome 1 Recurrent anterior wall prolapse.

Comparison 6 Vaginal repair versus abdominal repair, Outcome 2 Injury.
Figuras y tablas -
Analysis 6.2

Comparison 6 Vaginal repair versus abdominal repair, Outcome 2 Injury.

Comparison 6 Vaginal repair versus abdominal repair, Outcome 3 Posterior compartment prolapse.
Figuras y tablas -
Analysis 6.3

Comparison 6 Vaginal repair versus abdominal repair, Outcome 3 Posterior compartment prolapse.

Comparison 6 Vaginal repair versus abdominal repair, Outcome 4 POPQ assessment.
Figuras y tablas -
Analysis 6.4

Comparison 6 Vaginal repair versus abdominal repair, Outcome 4 POPQ assessment.

Comparison 6 Vaginal repair versus abdominal repair, Outcome 5 Dyspareunia.
Figuras y tablas -
Analysis 6.5

Comparison 6 Vaginal repair versus abdominal repair, Outcome 5 Dyspareunia.

Comparison 6 Vaginal repair versus abdominal repair, Outcome 6 Quality of life PROLAPSE.
Figuras y tablas -
Analysis 6.6

Comparison 6 Vaginal repair versus abdominal repair, Outcome 6 Quality of life PROLAPSE.

Comparison 6 Vaginal repair versus abdominal repair, Outcome 7 Operating time (minutes).
Figuras y tablas -
Analysis 6.7

Comparison 6 Vaginal repair versus abdominal repair, Outcome 7 Operating time (minutes).

Comparison 6 Vaginal repair versus abdominal repair, Outcome 8 Transfusion.
Figuras y tablas -
Analysis 6.8

Comparison 6 Vaginal repair versus abdominal repair, Outcome 8 Transfusion.

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 1 Awareness of prolapse.
Figuras y tablas -
Analysis 7.1

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 1 Awareness of prolapse.

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 2 Repeat surgery prolapse.
Figuras y tablas -
Analysis 7.2

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 2 Repeat surgery prolapse.

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 3 Recurrent anterior wall prolapse (stage 2 or greater).
Figuras y tablas -
Analysis 7.3

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 3 Recurrent anterior wall prolapse (stage 2 or greater).

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 4 Bladder injury.
Figuras y tablas -
Analysis 7.4

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 4 Bladder injury.

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 5 Stress urinary incontinence (de novo).
Figuras y tablas -
Analysis 7.5

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 5 Stress urinary incontinence (de novo).

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 6 Dyspareunia (de novo and persistent).
Figuras y tablas -
Analysis 7.6

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 6 Dyspareunia (de novo and persistent).

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 7 Quality of life PROLAPSE.
Figuras y tablas -
Analysis 7.7

Comparison 7 Native tissue repair versus graft repair for anterior and/or posterior prolapse, Outcome 7 Quality of life PROLAPSE.

Summary of findings for the main comparison. Anterior prolapse repair: native tissue versus biological graft in women with anterior compartment pelvic organ prolapse

Anterior prolapse repair: native tissue versus biological graft in women with anterior compartment pelvic organ prolapse

Patient or population: women with anterior compartment pelvic organ prolapse
Setting: hospital departments of obstetrics and gynaecology
Intervention: native tissue (anterior repair, colporrhaphy)

Comparison: biological graft

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Biological graft

Native tissue

Awareness of prolapse (1‐2 years)

124 per 1000

122 per 1000
(65 to 226)

RR 0.98
(0.52 to 1.82)

552
(5 studies)

⊕⊕⊕⊝
Lowa,b

Repeat surgery for prolapse (1‐2 years)

44 per 1000

45 per 1000
(23 to 86)

RR 1.02
(0.53 to 1.97)

650
(7 studies)

⊕⊕⊕⊝
Moderateb

Recurrent anterior compartment prolapse (1‐2 years)

257 per 1000

340 per 1000
(273 to 424)

RR 1.32
(1.06 to 1.65)

701
(8 studies)

⊕⊕⊝⊝
Moderatec

Stress urinary incontinence (1‐2 years)

130 per 1000

187 per 1000
(102 to 342)

RR 1.44
(0.79 to 2.64)

218
(2 studies)

⊕⊕⊕⊕
Moderateb

Repeat surgery for SUI was not reported by any studies

Dyspareunia (1‐2 years)

149 per 1000

129 per 1000
(58 to 287)

RR 0.87
(0.39 to 1.93)

151
(2 studies)

⊕⊕⊕⊝
Lowb,d

*The basis for the assumed risk is the mean control group risk across studies. 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.

aRisk of bias: allocation concealment not reported in 2/5, downgraded one level.

bSerious imprecision: wide confidence interval, greater than 25% increase in RR, downgraded one level.
cDowngraded one level for serious risk of bias: five of eight trials did not report blinded outcome assessment, downgraded one level.
dRisk of bias: blinded outcome assessment unreported in one of two trials, downgraded one level.

Figuras y tablas -
Summary of findings for the main comparison. Anterior prolapse repair: native tissue versus biological graft in women with anterior compartment pelvic organ prolapse
Summary of findings 2. Anterior prolapse repair: native tissue versus polypropylene mesh for women with anterior compartment pelvic organ prolapse

Anterior prolapse repair: native tissue versus polypropylene mesh for women with anterior compartment pelvic organ prolapse

Patient or population: women with anterior compartment pelvic organ prolapse

Setting: hospital departments of obstetrics and gynaecology
Intervention: native tissue (anterior repair, colporrhaphy)

Comparison: polypropylene mesh

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Polypropylene mesh repair

Native tissue repair

Awareness of prolapse (1‐3 years)

130 per 1000

230 per 1000
(178 to 297)

RR 1.77
(1.37 to 2.28)

1133
(9 studies)

⊕⊕⊕⊝
Moderate1

Repeat surgery for prolapse (1‐3 years)

18 per 1000

37 per 1000
(21 to 66)

RR 2.03
(1.15 to 3.58)

1629
(12 studies)

⊕⊕⊕⊝
Moderate2

Repeat surgery for stress urinary incontinence (1‐2 years)

29 per 1000

35 per 1000

(17 to 69)

RR 1.19

(0.60 to 2.36)

881

(5 studies)

Low3,4

Recurrent anterior compartment prolapse (1‐3 years)

126 per 1000

379 per 1000
(317 to 453)

RR 3.01
(2.52 to 3.60)

1976
(16 studies)

⊕⊕⊝⊝
Low5,6

Stress urinary incontinence (de novo) (1‐3 years)

102 per 1000

69 per 1000
(45 to 103)

RR 0.67
(0.44 to 1.01)

957
(6 studies)

⊕⊕⊝⊝
Low4,7

Dyspareunia (de novo) (1‐2 years)

72 per 1000

39 per 1000

(19 to 76)

RR 0.54

(0.27 to 1.06)

583

(8 studies)

⊕⊕⊕⊝
Low4,7

Repeat surgery for prolapse, SUI or mesh exposure (1‐3 years)

97 per 1000

54 per 1000

RR 0.59

(0.41 to 0.83)

1527

(12 studies)

⊕⊕⊕⊝
Moderate2

*The basis for the assumed risk is the mean control group risk across studies. 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.

1Risk of bias: allocation concealment not reported in 4/9, downgraded one level.
2Risk of bias: allocation concealment not reported in 6/12, downgraded one level.

3Risk of bias: allocation concealment not reported in 2/5: downgraded one level.

4Serious imprecision: wide CI with lower RR (0.25), downgraded one level.

5Risk of bias: 11/15 trials did not report blinded outcome assessment, downgraded one level.

6Risk of bias: allocation concealment not reported in 7/15, downgraded one level.

7Risk of bias: poor methodological reporting of allocation concealment and/or blinding, downgraded one level.

Figuras y tablas -
Summary of findings 2. Anterior prolapse repair: native tissue versus polypropylene mesh for women with anterior compartment pelvic organ prolapse
Summary of findings 3. Anterior prolapse repair: native tissue versus absorbable mesh for women with anterior and/or posterior compartment pelvic organ prolapse

Anterior prolapse repair: native tissue repair versus absorbable mesh for women with anterior and/or posterior compartment pelvic organ prolapse

Patient or population: women with anterior compartment pelvic organ prolapse

Setting: hospital departments of obstetrics and gynaecology
Intervention: native tissue repair (anterior colporrhaphy)
Comparison: absorbable mesh

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Absorbable mesh

Native tissue repair

Awareness of prolapse (2 years)

760 per 1000

722 per 1000
(532 to 996)

RR 0.95
(0.70 to 1.31)

54
(1 study)

⊕⊝⊝⊝
Very lowa,b,c

Repeat surgery for prolapse

(stage 2 or greater) at 2 years

59 per 1000

125 per 1000
(25 to 636)

RR 2.13
(0.42 to 10.82)

66
(1 study)

⊕⊝⊝⊝
Very lowa,b,c

Recurrent anterior compartment prolapse
(3 months to 2 years)

267 per 1000

401 per 1000
(291 to 550)

RR 1.50
(1.09 to 2.06)

268
(3 studies)

⊕⊕⊝⊝
Moderated

De novo dyspareunia

Not reported in the included studies

Stress urinary incontinence (2 years)

818 per 1000

589 per 1000
(409 to 859)

RR 0.72
(0.50 to 1.05)

49
(1 study)

⊕⊝⊝⊝
Very lowa,b,c

Repeat surgery for SUI was not reported by any studies

*The basis for the assumed risk is the mean control group risk across studies. 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.

aRisk of bias: at 2 years, 18% lost to review, downgraded one level.
bSerious imprecision: single small trial with confidence interval compatible with benefit in either arm or no effect. Low event rate, downgraded one level.
cPublication bias: evidence based on a single small trial, downgraded one level.

dRisk of bias: blinded outcome assessment not reported in 2/3 trials, and high attrition in one, downgraded one level.

Figuras y tablas -
Summary of findings 3. Anterior prolapse repair: native tissue versus absorbable mesh for women with anterior and/or posterior compartment pelvic organ prolapse
Table 1. Anterior transvaginal mesh exposure rate

Study ID

Mesh exposure

Mesh repairs

Al‐Nazer 2007

1

21

Ali 2006 abstract

3

46

Altman 2011

21

183

De Tayrac 2013

7

76

Delroy 2013

2

40

Gupta 2014

4

44

Lamblin 2014

2

33

Menefee 2011

5

28

Nguyen 2008

2

37

Nieminen 2008

18

104

Rudnick 2014

12

78

Sivaslioglu 2008

3

43

Tamanini 2014

7

42

Turgal 2014

3

20

Thijs 2010 abstract

9

48

Vollebregt 2011

2

53

Total

101

896

Anterior repair vs absorbable mesh

Sand 2001

0

73

Weber 2001

1

26

Figuras y tablas -
Table 1. Anterior transvaginal mesh exposure rate
Table 2. Reoperation for mesh exposure

Study ID

Surgery mesh exposure

Mesh repairs

Altman 2011 (1)

6

183

De Tayrac 2013 (2)

4

76

Delroy 2013 (3)

2

40

Gupta 2014 (4)

2

44

Nguyen 2008 (5)

2

37

Nieminen 2008 (6)

14

104

Rudnick 2014 (7)

5

78

Sivaslioglu 2008 (8)

3

43

Tamanini 2014 (9)

7

42

Turgal 2014

5

20

Thijs 2010 abstract (10)

4

48

Vollebregt 2011 (11)

2

53

Total

56

768

Figuras y tablas -
Table 2. Reoperation for mesh exposure
Table 3. Anterior and/or posterior mesh exposure

Study ID

Mesh exposure

Mesh repairs

Carey 2009

4

63

Withagen 2011

14

83

Total

18

146

Figuras y tablas -
Table 3. Anterior and/or posterior mesh exposure
Table 4. Reoperation for mesh exposure: anterior and/or posterior mesh repair

Study ID

Reoperation mesh exposure

Mesh repairs

Carey 2009

3

63

Withagen 2011

5

83

Total

8

146

Figuras y tablas -
Table 4. Reoperation for mesh exposure: anterior and/or posterior mesh repair
Comparison 1. Native tissue versus biological graft

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Awareness of prolapse Show forest plot

5

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 Anterior repair vs any biological graft

5

552

Risk Ratio (M‐H, Random, 95% CI)

0.98 [0.52, 1.82]

1.2 Anterior repair vs fascial plication with porcine dermis graft

3

384

Risk Ratio (M‐H, Random, 95% CI)

0.66 [0.21, 2.10]

2 Repeat surgery Show forest plot

7

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 Prolapse

7

650

Risk Ratio (M‐H, Fixed, 95% CI)

1.02 [0.53, 1.97]

3 Recurrent anterior compartment prolapse Show forest plot

8

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3.1 Anterior repair vs any biological graft

8

701

Risk Ratio (M‐H, Fixed, 95% CI)

1.32 [1.06, 1.65]

3.2 Anterior repair vs fascial plication with porcine dermis graft

4

392

Risk Ratio (M‐H, Fixed, 95% CI)

1.29 [0.98, 1.70]

4 Stress urinary incontinence Show forest plot

2

218

Risk Ratio (M‐H, Fixed, 95% CI)

1.44 [0.79, 2.64]

5 POPQ assessment Show forest plot

1

56

Mean Difference (IV, Fixed, 95% CI)

0.5 [0.02, 0.98]

5.1 Point Ba POPQ

1

56

Mean Difference (IV, Fixed, 95% CI)

0.5 [0.02, 0.98]

6 Urge incontinence Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

7 Voiding dysfunction Show forest plot

2

155

Risk Ratio (M‐H, Fixed, 95% CI)

1.13 [0.71, 1.80]

8 Dyspareunia Show forest plot

2

151

Risk Ratio (M‐H, Fixed, 95% CI)

0.87 [0.39, 1.93]

9 Quality of life PROLAPSE Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

9.1 Questionnaire (P‐QOL) 0‐100

1

56

Mean Difference (IV, Fixed, 95% CI)

‐1.0 [‐6.01, 4.01]

10 Operating time (minutes) Show forest plot

2

113

Mean Difference (IV, Fixed, 95% CI)

‐10.35 [‐14.45, ‐6.24]

11 Hospital stay Show forest plot

1

201

Mean Difference (IV, Fixed, 95% CI)

0.30 [‐0.09, 0.69]

Figuras y tablas -
Comparison 1. Native tissue versus biological graft
Comparison 2. Native tissue versus polypropylene mesh

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Awareness of prolapse Show forest plot

9

1133

Risk Ratio (M‐H, Fixed, 95% CI)

1.77 [1.37, 2.28]

2 Repeat surgery Show forest plot

13

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 Prolapse

12

1629

Risk Ratio (M‐H, Fixed, 95% CI)

2.03 [1.15, 3.58]

2.2 Reoperation for stress urinary incontinence (1‐3 years)

5

881

Risk Ratio (M‐H, Fixed, 95% CI)

1.19 [0.60, 2.36]

2.3 Surgery for prolapse, SUI or mesh exposure

12

1527

Risk Ratio (M‐H, Fixed, 95% CI)

0.59 [0.41, 0.83]

3 Recurrent anterior compartment prolapse Show forest plot

16

1976

Risk Ratio (M‐H, Fixed, 95% CI)

3.01 [2.52, 3.60]

3.1 Permanent mesh vs native tissue repair

16

1976

Risk Ratio (M‐H, Fixed, 95% CI)

3.01 [2.52, 3.60]

4 Bladder injury Show forest plot

6

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

4.1 Anterior repair vs any transvaginal polypropylene mesh

6

871

Risk Ratio (M‐H, Fixed, 95% CI)

0.21 [0.06, 0.82]

5 Apical or posterior compartment prolapse Show forest plot

2

300

Risk Ratio (M‐H, Fixed, 95% CI)

0.54 [0.30, 0.99]

6 POPQ assessment Show forest plot

6

Mean Difference (IV, Random, 95% CI)

Subtotals only

6.1 Point Ba POPQ

6

568

Mean Difference (IV, Random, 95% CI)

0.55 [0.30, 0.80]

6.2 Point Bp POPQ

3

276

Mean Difference (IV, Random, 95% CI)

‐0.43 [‐0.92, 0.06]

6.3 Point C POPQ

4

369

Mean Difference (IV, Random, 95% CI)

0.27 [‐0.47, 1.01]

6.4 Total vaginal length

3

366

Mean Difference (IV, Random, 95% CI)

‐0.18 [‐0.78, 0.43]

7 Stress urinary incontinence (de novo) Show forest plot

6

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

7.1 Polypropylene mesh vs native tissue (de novo)

6

957

Risk Ratio (M‐H, Fixed, 95% CI)

0.67 [0.44, 1.01]

8 De novo dyspareunia Show forest plot

8

583

Risk Ratio (M‐H, Fixed, 95% CI)

0.54 [0.27, 1.06]

9 Voiding dysfunction Show forest plot

3

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

9.1 Anterior repair vs polypropylene mesh (persistent)

3

277

Risk Ratio (M‐H, Fixed, 95% CI)

1.22 [0.33, 4.47]

10 Urge incontinence Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

10.1 Anterior repair vs transvaginal permanent mesh

2

198

Risk Ratio (M‐H, Fixed, 95% CI)

2.20 [0.33, 14.68]

11 Dyspareunia Show forest plot

8

1096

Risk Ratio (M‐H, Fixed, 95% CI)

1.06 [0.59, 1.90]

11.1 Anterior repair vs any transvaginal polypropylene mesh

8

1096

Risk Ratio (M‐H, Fixed, 95% CI)

1.06 [0.59, 1.90]

12 Quality of life PROLAPSE Show forest plot

8

Mean Difference (IV, Random, 95% CI)

Subtotals only

12.1 Questionnaire (PQOL) 0‐100

2

164

Mean Difference (IV, Random, 95% CI)

1.09 [‐1.19, 3.37]

12.2 Pelvic Floor Impact Questionnaire (PFIQ‐7) 0‐400

3

290

Mean Difference (IV, Random, 95% CI)

1.90 [‐7.78, 11.59]

12.3 Pelvic floor distress inventory (PFD1‐20) 0‐300

3

294

Mean Difference (IV, Random, 95% CI)

3.89 [‐12.82, 20.61]

12.4 Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ)

4

741

Mean Difference (IV, Random, 95% CI)

‐0.06 [‐0.76, 0.64]

12.5 ICIQ‐QOL

1

92

Mean Difference (IV, Random, 95% CI)

0.70 [‐0.15, 1.55]

12.6 ICIQ‐VS

1

92

Mean Difference (IV, Random, 95% CI)

1.10 [‐0.88, 3.08]

13 Hospital stay (days) Show forest plot

5

707

Mean Difference (IV, Random, 95% CI)

0.08 [‐0.17, 0.33]

14 Operating time (minutes) Show forest plot

7

1099

Mean Difference (IV, Random, 95% CI)

‐17.89 [‐25.81, ‐9.98]

15 Transfusion Show forest plot

4

486

Risk Ratio (M‐H, Fixed, 95% CI)

0.42 [0.24, 0.76]

Figuras y tablas -
Comparison 2. Native tissue versus polypropylene mesh
Comparison 3. Subgroup analysis: native tissue versus polypropylene mesh available for use

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Awareness of prolapse Show forest plot

5

518

Risk Ratio (M‐H, Fixed, 95% CI)

2.12 [1.35, 3.35]

2 Repeat surgery Show forest plot

7

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 Prolapse

7

815

Risk Ratio (M‐H, Fixed, 95% CI)

2.34 [1.20, 4.59]

2.2 Repeat surgery for stress urinary incontinence (1‐3 years)

2

333

Risk Ratio (M‐H, Fixed, 95% CI)

1.56 [0.60, 4.10]

2.3 Repeat surgery for prolapse, SUI or mesh exposure

6

648

Risk Ratio (M‐H, Fixed, 95% CI)

0.82 [0.55, 1.24]

3 Recurrent anterior compartment prolapse Show forest plot

8

970

Risk Ratio (M‐H, Fixed, 95% CI)

2.35 [1.83, 3.01]

3.1 Permanent mesh vs native tissue repair

8

970

Risk Ratio (M‐H, Fixed, 95% CI)

2.35 [1.83, 3.01]

Figuras y tablas -
Comparison 3. Subgroup analysis: native tissue versus polypropylene mesh available for use
Comparison 4. Native tissue versus absorbable mesh

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Awareness of prolapse (2‐year review) Show forest plot

1

54

Risk Ratio (M‐H, Fixed, 95% CI)

0.95 [0.70, 1.31]

2 Repeat surgery for prolapse (2 years) Show forest plot

1

66

Risk Ratio (M‐H, Fixed, 95% CI)

2.13 [0.42, 10.82]

3 Anterior compartment prolapse (3 months‐2 years) Show forest plot

3

268

Risk Ratio (M‐H, Fixed, 95% CI)

1.50 [1.09, 2.06]

4 Death Show forest plot

2

175

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Posterior compartment prolapse Show forest plot

1

132

Risk Ratio (M‐H, Fixed, 95% CI)

0.88 [0.31, 2.49]

6 Stress urinary incontinence Show forest plot

1

49

Risk Ratio (M‐H, Fixed, 95% CI)

0.72 [0.50, 1.05]

7 Quality of life Show forest plot

1

54

Mean Difference (IV, Fixed, 95% CI)

0.0 [‐2.82, 2.82]

7.1 VA QOL

1

54

Mean Difference (IV, Fixed, 95% CI)

0.0 [‐2.82, 2.82]

Figuras y tablas -
Comparison 4. Native tissue versus absorbable mesh
Comparison 5. Mesh versus biological graft

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Awareness of prolapse Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 Polypropylene mesh (Gynemesh) vs porcine dermis

1

190

Risk Ratio (M‐H, Fixed, 95% CI)

0.98 [0.20, 4.73]

2 Repeat surgery Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 Prolapse

2

315

Risk Ratio (M‐H, Fixed, 95% CI)

3.05 [0.87, 10.73]

3 Recurrent anterior wall compartment prolapse (stage 2 or greater) Show forest plot

2

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

3.1 Permanent mesh vs biological graft

1

190

Risk Ratio (M‐H, Random, 95% CI)

0.64 [0.43, 0.96]

3.2 Absorbable mesh vs biological graft

1

125

Risk Ratio (M‐H, Random, 95% CI)

3.22 [1.38, 7.52]

4 Mesh exposure Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

4.1 Polypropylene mesh vs porcine dermis

2

241

Risk Ratio (M‐H, Fixed, 95% CI)

0.09 [0.01, 0.69]

5 Stress urinary incontinence (de novo) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

5.1 Armed polypropylene mesh (Gynemesh) vs Pelvicol

1

190

Risk Ratio (M‐H, Fixed, 95% CI)

1.96 [0.18, 21.23]

6 Urgency, detrusor overactivity or overactive bladder (de novo) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

6.1 Armed polypropylene mesh (Gynemesh) vs Pelvicol

1

37

Risk Ratio (M‐H, Fixed, 95% CI)

0.47 [0.05, 4.78]

7 Dyspareunia (persistent) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

7.1 Armed polypropylene mesh (Gynemesh) vs Pelvicol

1

190

Risk Ratio (M‐H, Fixed, 95% CI)

0.82 [0.37, 1.80]

Figuras y tablas -
Comparison 5. Mesh versus biological graft
Comparison 6. Vaginal repair versus abdominal repair

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Recurrent anterior wall prolapse Show forest plot

2

118

Risk Ratio (M‐H, Random, 95% CI)

0.31 [0.03, 3.46]

2 Injury Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 Bladder

1

67

Risk Ratio (M‐H, Fixed, 95% CI)

0.97 [0.06, 14.88]

3 Posterior compartment prolapse Show forest plot

2

118

Risk Ratio (M‐H, Random, 95% CI)

1.81 [0.17, 19.65]

4 POPQ assessment Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

4.1 Point Ba POPQ

1

50

Mean Difference (IV, Fixed, 95% CI)

0.90 [‐0.15, 1.95]

4.2 Total vaginal length

1

68

Mean Difference (IV, Fixed, 95% CI)

3.20 [2.58, 3.82]

5 Dyspareunia Show forest plot

2

97

Risk Ratio (M‐H, Fixed, 95% CI)

5.17 [1.63, 16.35]

6 Quality of life PROLAPSE Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

6.1 Pelvic floor impact questionnaire (PFIQ‐7) 0‐400

1

50

Mean Difference (IV, Fixed, 95% CI)

‐9.0 [‐52.11, 34.11]

6.2 Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ)

1

50

Mean Difference (IV, Fixed, 95% CI)

‐2.0 [‐6.24, 2.24]

7 Operating time (minutes) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

8 Transfusion Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Figuras y tablas -
Comparison 6. Vaginal repair versus abdominal repair
Comparison 7. Native tissue repair versus graft repair for anterior and/or posterior prolapse

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Awareness of prolapse Show forest plot

3

406

Risk Ratio (M‐H, Random, 95% CI)

0.85 [0.36, 1.99]

1.1 Anterior and/or posterior repair vs polypropylene mesh

2

280

Risk Ratio (M‐H, Random, 95% CI)

1.17 [0.70, 1.96]

1.2 Anterior and/or posterior repair vs porcine dermis (Pelvicol)

1

126

Risk Ratio (M‐H, Random, 95% CI)

0.22 [0.05, 0.96]

2 Repeat surgery prolapse Show forest plot

2

291

Risk Ratio (M‐H, Fixed, 95% CI)

6.86 [0.86, 54.99]

2.1 Anterior and/or posterior repair vs polypropylene mesh

2

291

Risk Ratio (M‐H, Fixed, 95% CI)

6.86 [0.86, 54.99]

3 Recurrent anterior wall prolapse (stage 2 or greater) Show forest plot

3

492

Risk Ratio (M‐H, Fixed, 95% CI)

1.04 [0.77, 1.40]

3.1 Anterior colporrhaphy vs polypropylene mesh

2

280

Risk Ratio (M‐H, Fixed, 95% CI)

1.18 [0.70, 1.97]

3.2 Anterior colporrhaphy vs biological graft

1

87

Risk Ratio (M‐H, Fixed, 95% CI)

0.92 [0.65, 1.30]

3.3 Anterior and/or posterior repair vs biological graft

1

125

Risk Ratio (M‐H, Fixed, 95% CI)

1.08 [0.33, 3.56]

4 Bladder injury Show forest plot

1

166

Risk Ratio (M‐H, Fixed, 95% CI)

0.20 [0.01, 4.01]

5 Stress urinary incontinence (de novo) Show forest plot

1

105

Risk Ratio (M‐H, Fixed, 95% CI)

0.98 [0.34, 2.85]

6 Dyspareunia (de novo and persistent) Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

6.1 Anterior repair vs polypropylene mesh (de novo)

2

188

Risk Ratio (M‐H, Fixed, 95% CI)

1.23 [0.64, 2.36]

6.2 Anterior repair vs polypropylene mesh (persistent)

1

122

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.70, 1.52]

7 Quality of life PROLAPSE Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

7.1 Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ)

1

60

Mean Difference (IV, Fixed, 95% CI)

0.40 [‐2.74, 3.54]

Figuras y tablas -
Comparison 7. Native tissue repair versus graft repair for anterior and/or posterior prolapse