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Thermothérapie par micro‐ondes dans les cas d'hyperplasie bénigne de la prostate

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Referencias

References to studies included in this review

Abbou 1995 {published data only}

Abbou CC, Payan C, Viens‐Bitker C, Richard F, Boccon‐Gibod L, Jardin A, et al. Transrectal and transurethral hyperthermia versus sham treatment in benign prostatic hyperplasia: a double‐blind randomized multicentre clinical trial. British Journal of Urology 1995;76:619‐24.

Ahmed 1997 {published data only}

Ahmed M, Bell T, Lawrence WT, Ward JP, Watson GM. Transurethral microwave thermotherapy (Prostatron version 2.5) compared with transurethral resection of the prostate for the treatment of benign prostatic hyperplasia: a randomized, controlled, parallel study. British Journal of Urology 1997;79:181‐5.

Albala 2002 {published data only}

Albala DM, Fulmer BR, Turk TMT, Koleski F, Andriole G, Davis BE, et al. Office‐based transurethral microwave thermotherapy using the TherMatrx TMx‐2000. Journal of Endourology 2002;16:57‐61.

Bdesha 1994 {published data only}

Bdesha AS, Bunce CJ, Snell ME, Witherow RO. A sham controlled trial of transurethral microwave therapy with subsequent treatment of the control group. Journal of Urology 1994;152:453‐8.

Blute 1996 {published data only}

Blute ML, Patterson DE, Segura JW, Tomera KM, Hellerstein DK. Transurethral microwave thermotherapy v sham treatment: double‐blind randomized study. Journal of Endourology 1996;10:565‐73.

D'Ancona 1998 {published data only}

D'Ancona FC, Francisca EA, Witjes WP, Welling L, Debruyne FM, De La Rosette JJ. Transurethral resection of the prostate vs high‐energy thermotherapy of the prostate in patients with benign prostatic hyperplasia: long‐term results. British Journal of Urology 1998;81:259‐64.

Dahlstrand 1995 {published data only}

Dahlstrand C, Walden M, Geirsson G, Pettersson S. Transurethral microwave thermotherapy versus transurethral resection for symptomatic benign prostatic obstruction: a prospective randomized study with a 2‐year follow‐up. British Journal of Urology 1995;76:614‐8.

De Wildt 1996 {published data only}

De Wildt MJ, Hubregtse M, Ogden C, Carter SS, Debruyne FM, De la Rosette JJ. A 12‐month study of the placebo effect in transurethral microwave thermotherapy. British Journal of Urology 1996;77:221‐7.

Djavan 1999 {published data only}

Djavan B, Roehrborn CG, Shariat S, Ghawidel K, Marberger M. Prospective randomized comparison of high energy transurethral microwave thermotherapy versus alpha‐blocker treatment of patients with benign prostatic hyperplasia. Journal of Urology 1999;161:139‐43.

Floratos 2001 {published data only}

Floratos DL, Kiemeney LA, Rossi C, Kortmann BB, Debruyne FM, de La Rosette JJ. Long‐term followup of randomized transurethral microwave thermotherapy versus transurethral prostatic resection study. Journal of Urology 2001;165:1533‐8.

Larson 1998 {published data only}

Larson TR, Blute ML, Bruskewitz RC, Mayer RD, Ugarte RR, Utz WJ. A high‐efficiency microwave thermoablation system for the treatment of benign prostatic hyperplasia: results of a randomized, sham‐controlled, prospective, double‐blind, multicenter clinical trial. Urology 1998;51:731‐42.

Nawrocki 1997 {published data only}

Nawrocki JD, Bell TJ, Lawrence WT, Ward JP. A randomized controlled trial of transurethral microwave thermotherapy. British Journal of Urology 1997;79:389‐93.

Norby 2002a {published data only}

Norby B, Nielsen HV, Frimodt‐Moller PC. Transurethral interstitial laser coagulation of the prostate and transurethral microwave thermotherapy vs transurethral resection or incision of the prostate: results of a randomized, controlled study in patients with symptomatic benign prostatic hyperplasia. BJU International 2002;90:853‐62.

Roehrborn 1998 {published data only}

Roehrborn CG, Preminger G, Newhall P, Denstedt J, Razvi H, Chin LJ, et al. Microwave thermotherapy for benign prostatic hyperplasia with the Dornier Urowave: results of a randomized, double‐blind, multicenter, sham‐controlled trial. Urology 1998;51:19‐28.

Wagrell 2002 {published data only}

Wagrell L, Schelin S, Nordling J, Richthoff J, Mangnusson B, Schain M, et al. Feedback microwave thermotherapy versus TURP for clinical BPH − a randomized controlled multicenter study. Urology 2002;60:292‐9.

References to studies excluded from this review

Albala 2000 {published data only}

Albala DM, Turk TM, Fulmer BR, Koleski F, Andriole G, Davis BE, et al. Periurethral transurethral microwave thermotherapy for the treatment of benign prostatic hyperplasia: an interim 1‐year safety and efficacy analysis using the thermatrx TMx‐2000. Techniques in Urology 2000;6:288‐93.

Baert 1994 {published data only}

Baert L, Ameye F, Goethuys H, Petrovich Z. Microwave hyperthermia for the treatment of benign prostatic hyperplasia. Seminars in Urology 1994;12:174‐80.

Bdesha 1993 {published data only}

Bdesha AS, Bunce CJ, Kelleher JP, Snell ME, Vukusic J, Witherow RO. Transurethral microwave treatment for benign prostatic hypertrophy: a randomised controlled clinical trial. BMJ 1993;306:1293‐6.

Brehmer 1999 {published data only}

Brehmer M, Wiksell H, Kinn A. Sham treatment compared with 30 or 60 min of thermotherapy for benign prostatic hyperplasia: a randomized study. BJU International 1999;84:292‐6.

D'Ancona 1997 {published data only}

D'Ancona FC, Francisca EA, Witjes WP, Welling L, Debruyne FM, de la Rosette JJ. High energy thermotherapy versus transurethral resection in the treatment of benign prostatic hyperplasia: results of a prospective randomized study with 1 year of followup. Journal of Urology 1997;158:120‐5.

D'Ancona 1997b {published data only}

d Ancona FC, Francisca EA, Debruyne FM, de la Rosette JJ. High‐energy transurethral microwave thermotherapy in men with lower urinary tract symptoms. Journal of Endourology 1997;11:285‐9.

Dahlstrand 1993 {published data only}

Dahlstrand C, Geirsson G, Fall M, Pettersson S. Transurethral microwave thermotherapy versus transurethral resection for benign prostatic hyperplasia: preliminary results of a randomized study. European Urology 1993;23:292‐8.

Dahlstrand 1994 {published data only}

Dahlstrand C, Walden M, Geirsson G, Sommar S, Pettersson S. Transurethral microwave thermotherapy versus transurethral resection for BPH. Transurethral microwave thermotherapy versus transurethral resection for BPH. Progress in Clinical and Biological Research 1994;386:455‐61.

de la Rosette 1994 {published data only}

De La Rosette JJMCH, De Wilt MJAM, Alivizatos G, Froeling FMJA, Debruyne FMJ. Transurethral microwave thermotherapy (TUMT) in benign prostatic hyperplasia: placebo versus TUMT. Urology 1994;44:58‐63.

de la Rosette 2003 {published data only}

De La Rosette JJ, Floratos DL, Severens JL, Kiemeney LA, Debruyne FM, Pilar Laguna M. Transurethral resection vs microwave thermotherapy of the prostate: a cost‐consequences analysis. BJU International 2003;92:713‐8.

Djavan 1999b {published data only}

Djavan B, Shariat S, Fakhari M, Ghawidel K, Seitz C, Partin AW, et al. Neoadjuvant and adjuvant alpha‐blockade improves early results of high‐energy transurethral microwave thermotherapy for lower urinary tract symptoms of benign prostatic hyperplasia: a randomized, prospective clinical trial. Urology 1999;53:251‐9.

Djavan 2001 {published data only}

Djavan B, Seitz C, Roehrborn CG, Remzi M, Fakhari M, Waldert M, et al. Targeted transurethral microwave thermotherapy versus alpha‐blockade in benign prostatic hyperplasia: outcomes at 18 months. Urology 2001;57:66‐70.

Francisca 1997 {published data only}

Francisca EA, d Ancona FC, Hendriks JC, Kiemeney LA, Debruyne FM, de la Rosette JJ. Quality of life assessment in patients treated with lower energy thermotherapy (Prostasoft 2.0): results of a randomized transurethral microwave thermotherapy versus sham study. Journal of Urology 1997;158:1839‐44.

Francisca 2000 {published data only}

Francisca EA, d Ancona FC, Hendriks JC, Kiemeney LA, Debruyne FM, de La Rosette JJ. A randomized study comparing high‐energy TUMT to TURP: quality‐of‐life results. European Urology 2000;38:569‐75.

Kobelt 2004 {published data only}

Kobelt G, Spangberg A, Mattiasson A. The cost of feedback microwave thermotherapy compared with transurethral resection of the prostate for treating benign prostatic hyperplasia. BJU International 2004;93:543‐8.

Mattiasson 2007 {published data only}

Mattiasson A, Wagrell L, Schelin S, Nordling J, Richthoff J, Magnusson B, et al. Five‐year follow‐up of feedback microwave thermotherapy versus TURP for clinical BPH: a prospective randomized multicenter study. Urology 2007;69:91‐7.

Norby 2002b {published data only}

Norby B, Nielsen HV, Frimodt‐Moller PC. Cost‐effectiveness of new treatments for benign prostatic hyperplasia: results of a randomized trial comparing the short‐term cost‐effectiveness of transurethral interstitial laser coagulation of the prostate, transurethral microwave thermotherapy and standard transurethral resection or incision of the prostate. Scandinavian Journal of Urology and Nephrology 2002;36:286‐95.

Ogden 1993 {published data only}

Ogden CW, Reddy P, Johnson H, Ramsay JW, Carter SS. Sham versus transurethral microwave thermotherapy in patients with symptoms of benign prostatic bladder outflow obstruction. Lancet 1993;341:14‐7.

Schelin 2006 {published data only}

Schelin S, Geertsen U, Walter S, et al. Feedback microwave thermotherapy versus TURP/prostate enucleation surgery in patients with benign prostatic hyperplasia and persistent urinary retention: a prospective, randomized, controlled, multicenter study. Urology 2006;68:795‐9.

Shore 2010 {published data only}

Shore ND, Sethi PS. A controlled, randomized, head‐to‐head comparison of the Prolieve Thermodilation System versus the Targis System for benign prostatic hyperplasia: safety, procedural tolerability, and clinical results. Journal of Endourology 2010;24:2469‐75.

Tan 2005 {published data only}

Tan AH, Nott L, Hardie WR, Chin JL, Denstedt JD, Razvi H. Long‐term results of microwave thermotherapy for symptomatic benign prostatic hyperplasia. Journal of Endourology 2005;19:1191‐5.

Trachtenberg 1998 {published data only}

Trachtenberg J, Roehborn CG. Updated results of a randomized, double‐blind, multicenter sham‐controlled trial of microwave thermotherapy with the Dornier Urowave in patients with symptomatic benign prostatic hyperplasia. World Journal of Urology 1998;16:102‐8.

Trock 2004 {published data only}

Trock BJ, Brotzman M, Utz WJ, Ugarte RR, Kaplan SA, Larson TR, et al. Long‐term pooled analysis of multicenter studies of cooled thermotherapy for benign prostatic hyperplasia: results at three months through four years. Urology 2004;63:716‐21.

Venn 1995 {published data only}

Venn SN, Montgomery BS, Sheppard SA, Hughes SW, Beard RC, Bultitiude MI, et al. Microwave hyperthermia in benign prostatic hypertrophy: a controlled clinical trial. British Journal of Urology 1995;76:73‐6.

Wagrell 2004 {published data only}

Wagrell L, Schelin S, Nordling J, Richthoff J, Magnusson B, Schain M, et al. Three‐year follow‐up of feedback microwave thermotherapy versus TURP for clinical BPH: a prospective randomized multicenter study. Urology 2004;64:698‐702.

Walden 1998 {published data only}

Walden M, Acosta S, Carlsson P, Pettersson S, Dahlstrand C. A cost‐effectiveness analysis of transurethral resection of the prostate and transurethral microwave thermotherapy for treatment of benign prostatic hyperplasia: two‐year follow‐up. Scandinavian Journal of Urology and Nephrology 1998;32:204‐10.

Zerbib 1992 {published data only}

Zerbib M, Steg A, Conquy S, Martinache PR, Flam TA, Debre B. Localized hyperthermia versus the sham procedure in obstructive benign hyperplasia of the prostate: a prospective randomized study. Journal of Urology 1992;147:1048‐52.

Zerbib 1994 {published data only}

Zerbib M, Steg A, Conquy S, Debre B. Hyperthermia: a randomized prospective study applying hyperthermia or a sham procedure in obstructive benign hyperplasia of the prostate. Progress in Clinical and Biological Research 1994;386:439‐48.

Additional references

AUA 2011

McVary KT, Roehrborn CG, Avins AL, Barry MJ, Bruskewitz RC, Donnell RF, et al. Update on AUA Guideline on the management of benign prostatic hyperplasia. Journal of Urology 2011;185:1793‐803.

Barry 1990

Barry MJ. Medical outcomes research and benign prostatic hyperplasia. Prostate 1990;3 Suppl:61‐74.

Bolmsjo 1996

Bolmsjo M, Wagrell L, Hallin A, Eliasson T, Erlandsson BE, Matiasson A. The heat is on − but how? A comparison of TUMT devices. British Journal of Urology 1996;78:564‐72.

Borboroglu 1999

Borboroglu PG, Kane CJ, Ward JF, Roberts JL, Sands JP. Immediate and postoperative complications of transurethral prostatectomy in the 1990s. Journal of Urology 1999;162:1307‐10.

Chapple 2001

Chapple CR. Lower urinary tract symptoms suggestive of benign prostatic obstruction‐Triumph: design and implementation. European Urology 2001;39 Suppl:31‐6.

Cochrane Handbook 2011

Higgins JPT, Altman DG, Stern JAC. Chapter 8. Assessing risk of bias in included studies. Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews Version 5.1.0. The Cochrane Collaboration, March 2011.

CUA 2010

Nickel JC, Mendez‐Probst CE, Whelan TF, Paterson RF, Razvi H. 2010 update: guidelines for the management of benign prostatic hyperplasia. Canadian Urological Association Journal 2010;4:310‐6.

EAU 2002

de la Rosette J, Alivizatos G, Madersbacher S, Sanz CR, Nordling J, Emberton M. European Association of Urology Guidelines on benign prostatic hyperplasia. European Urology 2001;40:256‐63.

FDA 2000

United States Food, Drug Administration. FDA Public Health Notification: Serious Injuries from Microwave Thermotherapy for Benign Prostatic Hyperplasia. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062277.htm (accessed 3 February 2012) October 11, 2000.

GRADEPro 2008 [Computer program]

Brozek J, Oxman A, Schϋnemann H. GRADEPro. Version Version 3.2 for WIndows 2008.

Jepsen 1998

Jepsen JV, Bruskewitz RC. Recent developments in the surgical management of benign prostatic hyperplasia. Urology 1998;51(Suppl 4A):23‐31.

McConnell 1994

McConnell JD, Barry MJ, Bruskewitz RC, Bueschan AJ, Denton SE, Holtgrewe HL, et al. Benign prostatic hyperplasia: diagnosis and treatment. Clinical Practice Guidelines. Rockville, Maryland: U.S. Department of Health and Human Services. Public Health Service. Agency for Health Care Policy and Research: AHCPR Publication No. 94‐0582, 1994.

Mebust 1989

Mebust WK, Holtgrewe HL, Cockett AT, Peters PC. Transurethral prostatectomy: immediate and postoperative complications. A cooperative study of 13 participating institutions evaluating 3,885 patients. Journal of Urology 1989;141:243‐7.

Roos 1998

Roos NP, Wennberg JE, Malenka DJ, Fisher ES, McPherson K, Andersen TF, et al. Mortality and reoperation after open and transurethral resection of the prostate for benign prostatic hyperplasia. New England Journal of Medicine 1989;320:1120‐4.

Schulz 1995

Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodologically quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273:408‐12.

Walmsley 2004

Walmsley K, Kaplan SA. Transurethral microwave thermotherapy for benign prostate hyperplasia: separating truth from marketing hype. Journal of Urology 2004;172:1249‐55.

Wasson 1995

Wasson JH, Reda DJ, Bruskewitz RC, Elinson J, Keller AM, Henderson WG. Comparison of transurethral surgery with watchful waiting for moderate symptoms of benign prostatic hyperplasia. New England Journal of Medicine 1995;332:75‐9.

Wei 2004

Wei JT, Calhoun EA, Jacobsen SJ. Chapter 2. Benign prostatic hyperplasia. Urologic Diseases in America, Litwin MS, Saigal CS, editors. Washington, DC: US Department of Health and Human Services, Public Health Service, National Institute of Diabetes and Digestive and Kidney Diseases: US Government Publishing Office; NIH Publication No. 04‐55112, 2004:43‐70.

Yu 2008

Yu X, Elliott SP, Wilt TJ, McBean AM. Practic patterns in benign prostatic hyperplasia surgical therapy: the dramatic increase in minimally invasive technologies. Journal of Urology 2008;180:241‐5.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Abbou 1995

Methods

Multicenter
Randomized
Subjects and investigators blinded

Participants

French men, mean age 65, with symptomatic BPH, peak urinary flow < 15 mL/s with voided volume > 150 mL; prostate volume 30 to 80 cc; post‐void residual < 300 cc.
Lost to follow‐up: 2

Interventions

1. TUMT (n = 66)
Thermex II; Prostcare; BSD‐50
2. Transrectal thermotherapy (n = 65)
2. Sham control (n = 69)
Study duration: 1 year

Outcomes

Adverse events

Notes

No evaluable symptom or urinary flow data provided

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Permutation tables

Allocation concealment (selection bias)

Unclear risk

Not documented

Incomplete outcome data (attrition bias)
All outcomes

High risk

57/200 subjects unavailable for follow‐up, investigators classified outcomes "to maximize bias."

Selective reporting (reporting bias)

Low risk

Adequate

Other bias

Low risk

Adequate

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Adequate

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Adequate

Ahmed 1997

Methods

Single center
Randomized
Subjects and providers not blinded

Participants

British men, mean age 69 (range 56 to 88); urodynamically obstructive BPH; AUA symptom score > 12; peak urinary flow < 15 mL/s.
Lost to follow‐up: 0

Interventions

1. TUMT (n = 30)
Prostatron/Prostasoft 2.5
2. TURP (n = 30)
Study duration: 6 months

Outcomes

AUA symptom score, peak urinary flow, voiding pressure, residual volume, prostate size, adverse events

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Patients failing to complete treatment or return for follow‐up were "substituted."

Allocation concealment (selection bias)

Unclear risk

Describes only "sealed envelope"

Incomplete outcome data (attrition bias)
All outcomes

High risk

Due to "substitution" noted above, number not provided.

Selective reporting (reporting bias)

Low risk

Adequate

Other bias

Low risk

Adequate

Blinding of participants and personnel (performance bias)
All outcomes

High risk

TUMT versus TURP

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not mentioned

Albala 2002

Methods

Multicenter

Randomized

Subjects and outcome assessor blinded

Participants

US men, mean age 65 (range 50 to 80); AUA symptom score > 13; peak urinary flow < 12 ml/s

Lost to follow‐up: 0

Interventions

1. TUMT (n = 125)

TherMatrx TMx‐2000

2. Sham (n = 65)

Study duration: 3 months

Outcomes

AUA symptom score; peak urinary flow; adverse events; bother score; quality of life

Notes

Study unblinded with cross‐over at 3 months and follow‐up to 1 year.

Instruments used to measure bother and quality of life not reported.

Mean PUF not reported at follow‐up.

No standard deviation reported with mean AUA score

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not mentioned

Allocation concealment (selection bias)

Unclear risk

Not mentioned

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition documented

Selective reporting (reporting bias)

Low risk

Adequate

Other bias

Low risk

Adequate

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Adequate

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Adequate

Bdesha 1994

Methods

Single center
Randomized
Subjects and investigators blinded

Participants

British men, mean age 63, symptomatic BPH eligible for surgery. AUA symptom score > 10, peak urinary flow < 15 mL/s, prostate length < 40 mm; post‐void residual < 200 mL
Lost to follow‐up: 2 (3 months), 8 (1 year)

Interventions

1. TUMT (n = 22)
LEO Microthermer
2. Sham control (n = 18)
Study duration: 12 months

Outcomes

AUA symptom score, modified World Health Organization symptom score, peak urinary flow, rehospitalization/retreatment, residual volume, adverse events

Notes

Study unblinded with cross‐over at 3 months and follow‐up to 1 year

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not mentioned

Allocation concealment (selection bias)

Unclear risk

Describes only "sealed envelope"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition documented

Selective reporting (reporting bias)

Low risk

Adequate

Other bias

Low risk

Adequate

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Adequate

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Adequate

Blute 1996

Methods

Single center
Randomized
Subjects and outcomes assessors blinded

Participants

American men, mean age 67, symptomatic BPH. Madsen symptom score > 8; PFR < 10 mL/s with voided volume > 150 mL; post‐void residual 100 to 200 mL; prostate length 35 to 50 mm.
Lost to follow‐up: 7 total (3 months), 15 TUMT patients (1 year)

Interventions

1. TUMT (n = 78)
Prostatron/Prostasoft 2.0
2. Sham control (n = 37)
Study duration: 12 months

Outcomes

Madsen‐Iversen symptom score, AUA symptom score, global assessment of improvement, peak urinary flow, residual volume, prostate size, adverse events

Notes

Study unblinded with cross‐over at 3 months with follow‐up to 1 year

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not mentioned

Allocation concealment (selection bias)

Low risk

Sealed envelopes identified only by a unique patient number

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition documented

Selective reporting (reporting bias)

Low risk

Adequate

Other bias

Low risk

Adequate

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Adequate

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Adequate

D'Ancona 1998

Methods

Single center
Randomized
Subjects and providers not blinded

Participants

Dutch men, mean age 69 (range 54 to 89), symptomatic BPH eligible for TURP. Madsen symptom score > 7, peak urinary flow ≤ 15 mL/s with voided volume > 100 mL; prostate length 25 to 50 mm, prostate volume 30 to 100 cc, post‐void residual < 350 mL
Lost to follow‐up: 8 (1 year), 11 (2.5 years)

Interventions

1. TUMT (n = 31)
Prostatron/Prostasoft 2.5
2. TURP (n = 21)
Follow‐up duration: 2.5 years

Outcomes

Madsen‐Iversen symptom score, IPSS symptom score, peak urinary flow, rehospitalization/retreatment, hospital length of stay, residual volume, prostate size, adverse events

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not mentioned

Allocation concealment (selection bias)

Unclear risk

Not mentioned

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition documented

Selective reporting (reporting bias)

Low risk

Adequate

Other bias

Low risk

Adequate

Blinding of participants and personnel (performance bias)
All outcomes

High risk

TUMT versus TURP

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not mentioned

Dahlstrand 1995

Methods

Single center
Randomized
Subjects and providers not blinded

Participants

Swedish men, mean age 68, symptomatic BPH eligible for TURP. Madsen > 7; peak urinary flow < 15 mL/s with voided volume > 150 mL; prostate length 35 to 50 mm; prostate volume 25‐100 cc.
Lost to follow‐up: 5 (1 year), 8 (2 years)

Interventions

1. TUMT (n = 37)
Prostatron/Prostasoft 2.0
2. TURP (n = 32)
Study duration: 2 years

Outcomes

Madsen‐Iversen symptom score, peak urinary flow, rehospitalization/retreatment, hospital length of stay, residual volume, prostate size, adverse events

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not mentioned

Allocation concealment (selection bias)

Unclear risk

Not mentioned

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition documented

Selective reporting (reporting bias)

Low risk

Adequate

Other bias

Low risk

Adequate

Blinding of participants and personnel (performance bias)
All outcomes

High risk

TUMT versus TURP

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not mentioned

De Wildt 1996

Methods

Multicenter
Randomized
Subjects, providers, and outcomes assessors blinded

Participants

Dutch and British men, mean age 65, symptomatic BPH. Madsen symptom score > 8; peak urinary flow < 15 mL/s. Post‐void residual < 300 mL
Lost to follow‐up: 2 (3 months)

Interventions

1. TUMT (n = 47)
Prostatron/Prostasoft 2.0
2. Sham control (n = 46)
Study duration: 1 year.

Outcomes

Madsen‐Iversen symptom score, quality of life, peak urinary flow, rehospitalization/retreatment, residual volume, adverse events

Notes

Study unblinded with cross‐over at 3 months with follow‐up to 1 year

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not mentioned

Allocation concealment (selection bias)

Unclear risk

Not mentioned

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Adequate

Selective reporting (reporting bias)

Low risk

Adequate

Other bias

Low risk

Adequate

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Adequate

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Adequate

Djavan 1999

Methods

Single center
Randomized
Subjects and providers not blinded

Participants

Austrian men, mean age 65 (range 45 to 85), symptomatic BPH. IPSS symptom score > 8; peak urinary flow < 12 mL/s with voided volume ≥ 150 mL; prostatic urethra length 30 to 50 mm; post‐void residual ≤ 250 mL; prostate size < 100 cc
Lost to follow‐up: 10 ( 6 months), 27 (18 months)

Interventions

1. TUMT (n = 51)
Targis
2. Terazosin (n = 52)
Study duration: 18 months

Outcomes

IPSS symptom score, quality of life, peak urinary flow, rehospitalization/retreatment, adverse events

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Alternating group assignments of consecutive patients one by one

Allocation concealment (selection bias)

High risk

Alternating group assignments of consecutive patients one by one

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Higher proportion (> 10%) of dropouts among alpha blocker group

Selective reporting (reporting bias)

Low risk

Adequate

Other bias

Low risk

Adequate

Blinding of participants and personnel (performance bias)
All outcomes

High risk

TUMT versus oral medication

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not mentioned

Floratos 2001

Methods

Single center
Randomized
Subjects and providers not blinded

Participants

Dutch men, mean age 67, symptomatic BPH. Madsen symptom score > 7, peak urinary flow ≤ 15 mL/s; prostate length ≥ 25 mm; prostate volume ≥ 30 cc
Lost to follow‐up: 35 (1 year), 71 (3 years)

Interventions

1. TUMT (n = 78)
Prostatron/Prostasoft 2.5
2. TURP (n = 66)
Study duration: 3 years

Outcomes

Madsen‐Iversen symptom score, IPSS symptom score, quality of life, peak urinary flow, rehospitalization/retreatment, alpha blocker/anticholinergic treatment, residual volume, prostate size, adverse events

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not mentioned

Allocation concealment (selection bias)

Unclear risk

Not mentioned

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition documented

Selective reporting (reporting bias)

Low risk

Adequate

Other bias

Low risk

Adequate

Blinding of participants and personnel (performance bias)
All outcomes

High risk

TUMT versus TURP

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not mentioned

Larson 1998

Methods

Multicenter
Randomized
Subjects and providers blinded

Participants

American men, mean age 66, symptomatic BPH. AUA symptom score > 8; peak urinary flow ≤ 12 mL/s with voided volume ≥ 125 mL; prostatic urethra length 30 to 50 mm
Lost to follow‐up: 14

Interventions

1. TUMT (n = 125)
Targis
2. Sham control (n = 44)
Study duration: 6 months

Outcomes

AUA symptom score, peak urinary flow, quality of life, rehospitalization/retreatment, hospital length of stay, residual volume, prostate size, adverse events

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not mentioned

Allocation concealment (selection bias)

Unclear risk

Not mentioned

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition documented

Selective reporting (reporting bias)

Low risk

Adequate

Other bias

Low risk

Adequate

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Adequate

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not mentioned

Nawrocki 1997

Methods

Single center
Randomized
Subjects, providers blinded

Participants

British men, median age 70 (range 56 to 80), symptomatic BPH eligible for TURP; peak urinary flow < 15 mL/s with voided volume ≥ 150 mL.; prostate urethra < 30 mm; post‐void residual < 350 mL
Lost to follow‐up: Unknown

Interventions

1. TUMT (n = 38)
Prostatron/Prostasoft 2.0
2. Sham control (n = 40)
3. No treatment (n = 42)
Study duration: 6 months

Outcomes

AUA symptom score, peak urinary flow, residual volume, prostate size, adverse events

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Randomized by selecting one of three differently numbered but otherwise identical balls from a sealed bag

Allocation concealment (selection bias)

Low risk

Adequate

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition documented

Selective reporting (reporting bias)

Low risk

Adequate

Other bias

Low risk

Adequate

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Adequate

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not mentioned

Norby 2002a

Methods

Two centers
Randomized
Subjects and providers not blinded

Participants

Danish men, mean age 67, symptomatic BPH. IPSS symptom score > 6; peak urinary flow < 12 mL/s; prostatic urethra ≥ 25 mm; post‐void residual ≤ 350 mL
Lost to follow‐up: 0

Interventions

1. TUMT (n = 46)
Prostatron/Prostasoft 2.0, 2.5
2. TURP/TUIP (n = 22)
3. Interstitial laser coagulation (n = 44)
Study duration: 6 months

Outcomes

IPSS symptom score, quality of life, peak urinary flow, rehospitalization/retreatment, hospital length of stay, residual volume, prostate size, adverse events

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not mentioned

Allocation concealment (selection bias)

Unclear risk

Not mentioned

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition documented

Selective reporting (reporting bias)

Low risk

Adequate

Other bias

Low risk

Adequate

Blinding of participants and personnel (performance bias)
All outcomes

High risk

TUMT versus laser versus TURP/TUIP

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not mentioned

Roehrborn 1998

Methods

Multicenter
Randomized
Subjects, providers, and outcomes assessors blinded

Participants

American and Canadian men, mean age 66, symptomatic BPH. AUA symptom score > 13; peak urinary flow < 13 mL/s with voided volume > 125 mL; prostate volume 25‐100 cc; prostatic urethra ≤ 30 mm
Lost to follow‐up: 23

Interventions

1. TUMT (n = 147)
Dornier Urowave
2. Sham control (n = 73)
Study duration: 6 months

Outcomes

AUA symptom score, quality of life, peak urinary flow, rehospitalization/retreatment, residual volume, prostate size, adverse events

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not mentioned

Allocation concealment (selection bias)

Unclear risk

Not mentioned

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Higher proportion (> 10%) lost to follow‐up in TUMT group

Selective reporting (reporting bias)

Low risk

Adequate

Other bias

Low risk

Adequate

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Adequate

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Adequate

Wagrell 2002

Methods

Multicenter
Randomized
Subjects and providers not blinded

Participants

Scandinavian and American men, mean age 68, symptomatic BPH. IPSS symptom score > 12; peak urinary flow < 13 mL/s; prostate volume 30 to 100 cc
Lost to follow‐up: 13 (1 year), 43 (3 years)

Interventions

1. TUMT (n = 100)
ProstaLund Feedback Treatment
2. TURP (n = 46)
Study duration: 3 years

Outcomes

IPSS symptom score, quality of life, peak urinary flow, rehospitalization/retreatment, residual volume, prostate size, adverse events

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not mentioned

Allocation concealment (selection bias)

Unclear risk

Not mentioned

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

21/154 did not complete the study, similar proportions in each arm

Selective reporting (reporting bias)

Low risk

Adequate

Other bias

Low risk

Adequate

Blinding of participants and personnel (performance bias)
All outcomes

High risk

TUMT versus TURP

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Adequate

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Albala 2000

Variant technique: periurethral; cross‐over at 3 months with no interpretable outcome data

Baert 1994

Hyperthermia

Bdesha 1993

Superseded by Bdesha 1994

Brehmer 1999

Four‐month follow‐up, outcome data not interpretable; ICS symptom index, no complication data

D'Ancona 1997

Superseded by D'Ancona 1998

D'Ancona 1997b

Superseded by D'Ancona 1998

Dahlstrand 1993

Superseded by Dahlstrand 1995

Dahlstrand 1994

Superseded by Dahlstrand 1995

de la Rosette 1994

Superseded by De Wildt 1996, (combined UK Netherlands) versus Netherlands

de la Rosette 2003

Economic data only

Djavan 1999b

TUMT ± neoadjuvant alpha‐blocker

Djavan 2001

18‐month f/u, large loss to follow‐up. 6‐month data (Journal of Urology 1999) used in analyses

Francisca 1997

Superseded by De Wildt 1996 (combined UK, Netherlands) versus UK

Francisca 2000

Duplicates Floratos 2001

Kobelt 2004

Economic data only

Mattiasson 2007

5‐year outcome data from Wagrell 2002, 34% loss to follow‐up

Norby 2002b

Economic data only

Ogden 1993

Superseded by De Wildt 1996

Schelin 2006

Men with persistent urinary retention

Shore 2010

Compared two similar energy TUMT systems that differed only by an adjunct balloon dilator

Tan 2005

Long‐term follow‐up of the sham crossed‐over group, no longer randomized. Very small sample size

Trachtenberg 1998

Duplicates Roehrborn 1998

Trock 2004

Pooled observational with previously extracted RCT data

Venn 1995

3‐month cross‐over, outcome data un interpretable, no complication data

Wagrell 2004

Long‐term follow‐up of Wagrell 2002. Substantial loss to follow‐up (31/99 in TUMT; 11/46 in TURP)

Walden 1998

Economic data only

Zerbib 1992

Hyperthermia

Zerbib 1994

Hyperthermia

Data and analyses

Open in table viewer
Comparison 1. Microwave thermotherapy versus transurethral resection of the prostate (TURP)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 International Prostate Symptom Score (IPSS): 6 mos ‐ 1 year follow‐up Show forest plot

4

306

Mean Difference (IV, Random, 95% CI)

1.00 [‐2.03, 0.03]

Analysis 1.1

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 1 International Prostate Symptom Score (IPSS): 6 mos ‐ 1 year follow‐up.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 1 International Prostate Symptom Score (IPSS): 6 mos ‐ 1 year follow‐up.

1.1 ProstaLund Feedback Treatment

1

136

Mean Difference (IV, Random, 95% CI)

‐0.10 [‐2.44, 2.24]

1.2 Prostatron (high‐energy Prostasoft 2.5)

2

104

Mean Difference (IV, Random, 95% CI)

‐0.95 [‐2.40, 0.51]

1.3 Prostatron (Prostasoft 2.0 and 2.5)

1

66

Mean Difference (IV, Random, 95% CI)

‐2.7 [‐5.87, 0.47]

2 Madsen‐Iversen Symptom Score (range 0 to 27): 6 mos ‐ 1 year follow‐up Show forest plot

2

108

Mean Difference (IV, Fixed, 95% CI)

1.59 [0.69, 2.48]

Analysis 1.2

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 2 Madsen‐Iversen Symptom Score (range 0 to 27): 6 mos ‐ 1 year follow‐up.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 2 Madsen‐Iversen Symptom Score (range 0 to 27): 6 mos ‐ 1 year follow‐up.

2.1 Prostatron (high‐energy Prostasoft 2.5)

1

44

Mean Difference (IV, Fixed, 95% CI)

1.5 [‐1.07, 4.07]

2.2 Prostatron (low‐energy Prostasoft 2.0)

1

64

Mean Difference (IV, Fixed, 95% CI)

1.6 [0.64, 2.56]

3 50% Improvement in AUA Symptom Score: # subjects Show forest plot

2

121

Risk Ratio (M‐H, Random, 95% CI)

0.74 [0.50, 1.09]

Analysis 1.3

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 3 50% Improvement in AUA Symptom Score: # subjects.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 3 50% Improvement in AUA Symptom Score: # subjects.

4 Peak Flow Rate (Qmax): 6 mos ‐ 1 year follow‐up Show forest plot

5

338

Mean Difference (IV, Fixed, 95% CI)

5.08 [3.88, 6.28]

Analysis 1.4

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 4 Peak Flow Rate (Qmax): 6 mos ‐ 1 year follow‐up.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 4 Peak Flow Rate (Qmax): 6 mos ‐ 1 year follow‐up.

4.1 ProstaLund Feedback Treatment

1

104

Mean Difference (IV, Fixed, 95% CI)

1.90 [‐1.17, 4.97]

4.2 Prostatron (high‐energy Prostasoft 2.5)

2

104

Mean Difference (IV, Fixed, 95% CI)

5.26 [3.67, 6.85]

4.3 Prostatron (low‐energy Prostasoft 2.0)

1

64

Mean Difference (IV, Fixed, 95% CI)

6.30 [3.80, 8.80]

4.4 Prostatron (Prostasoft 2.0 and 2.5)

1

66

Mean Difference (IV, Fixed, 95% CI)

7.40 [1.68, 13.12]

5 Hematuria (requiring additional treatment/judged to be serious) Show forest plot

3

258

Risk Difference (M‐H, Random, 95% CI)

‐0.05 [‐0.15, 0.05]

Analysis 1.5

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 5 Hematuria (requiring additional treatment/judged to be serious).

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 5 Hematuria (requiring additional treatment/judged to be serious).

6 Urinary retention Show forest plot

4

343

Risk Ratio (M‐H, Fixed, 95% CI)

2.94 [1.52, 5.70]

Analysis 1.6

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 6 Urinary retention.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 6 Urinary retention.

7 Dysuria/Urgency Show forest plot

3

277

Risk Ratio (M‐H, Fixed, 95% CI)

2.22 [1.28, 3.86]

Analysis 1.7

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 7 Dysuria/Urgency.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 7 Dysuria/Urgency.

8 Urinary tract infections/epididymitis/orchitis Show forest plot

5

395

Risk Ratio (M‐H, Fixed, 95% CI)

1.15 [0.70, 1.86]

Analysis 1.8

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 8 Urinary tract infections/epididymitis/orchitis.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 8 Urinary tract infections/epididymitis/orchitis.

9 Retrograde ejaculation (sexually active men only) Show forest plot

2

78

Risk Difference (M‐H, Fixed, 95% CI)

‐0.34 [‐0.55, ‐0.13]

Analysis 1.9

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 9 Retrograde ejaculation (sexually active men only).

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 9 Retrograde ejaculation (sexually active men only).

10 Erectile dysfunction Show forest plot

3

212

Risk Ratio (M‐H, Fixed, 95% CI)

0.41 [0.16, 1.05]

Analysis 1.10

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 10 Erectile dysfunction.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 10 Erectile dysfunction.

11 Repeat treatments/Reoperations up to 1 year Show forest plot

4

335

Risk Ratio (M‐H, Fixed, 95% CI)

1.76 [0.54, 5.70]

Analysis 1.11

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 11 Repeat treatments/Reoperations up to 1 year.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 11 Repeat treatments/Reoperations up to 1 year.

12 Urethral/bladder neck strictures Show forest plot

3

197

Risk Ratio (M‐H, Fixed, 95% CI)

0.13 [0.02, 0.71]

Analysis 1.12

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 12 Urethral/bladder neck strictures.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 12 Urethral/bladder neck strictures.

13 Transfusions Show forest plot

2

128

Risk Difference (M‐H, Fixed, 95% CI)

‐0.11 [‐0.21, ‐0.02]

Analysis 1.13

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 13 Transfusions.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 13 Transfusions.

14 Clot retention Show forest plot

3

283

Risk Ratio (M‐H, Fixed, 95% CI)

0.27 [0.06, 1.31]

Analysis 1.14

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 14 Clot retention.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 14 Clot retention.

15 TURP Syndrome Show forest plot

3

274

Risk Difference (M‐H, Fixed, 95% CI)

‐0.05 [‐0.11, ‐0.00]

Analysis 1.15

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 15 TURP Syndrome.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 15 TURP Syndrome.

Open in table viewer
Comparison 2. Microwave thermotherapy versus sham treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 International Prostate Symptom Score (IPSS) Show forest plot

4

482

Mean Difference (IV, Fixed, 95% CI)

‐5.15 [‐6.04, ‐4.26]

Analysis 2.1

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 1 International Prostate Symptom Score (IPSS).

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 1 International Prostate Symptom Score (IPSS).

1.1 LEO Microthermer: 3 months follow‐up

1

40

Mean Difference (IV, Fixed, 95% CI)

‐9.1 [‐15.64, ‐2.56]

1.2 Prostatron (Prostasoft 2.0): 3/6 months follow‐up

1

94

Mean Difference (IV, Fixed, 95% CI)

‐5.0 [‐8.09, ‐1.91]

1.3 Dornier Urowave: 6 months follow‐up

1

193

Mean Difference (IV, Fixed, 95% CI)

‐5.30 [‐6.32, ‐4.28]

1.4 Urologix Targis system: 6 months follow‐up

1

155

Mean Difference (IV, Fixed, 95% CI)

‐3.80 [‐6.26, ‐1.34]

2 Madsen Symptom Score Show forest plot

2

196

Mean Difference (IV, Fixed, 95% CI)

‐5.10 [‐6.42, ‐3.79]

Analysis 2.2

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 2 Madsen Symptom Score.

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 2 Madsen Symptom Score.

2.1 Prostatron (Prostasoft): 3 months follow‐up

1

108

Mean Difference (IV, Fixed, 95% CI)

‐4.50 [‐6.37, ‐2.63]

2.2 Prostatron (Prostasoft 2.0): 3 months follow‐up

1

88

Mean Difference (IV, Fixed, 95% CI)

‐5.7 [‐7.56, ‐3.84]

3 Peak Flow Rate (Qmax) Show forest plot

6

643

Mean Difference (IV, Random, 95% CI)

2.01 [0.85, 3.16]

Analysis 2.3

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 3 Peak Flow Rate (Qmax).

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 3 Peak Flow Rate (Qmax).

3.1 LEO Microthermer: 3 months follow‐up

1

40

Mean Difference (IV, Random, 95% CI)

4.80 [1.98, 7.62]

3.2 Prostatron (Prostasoft): 3 months follow‐up

1

108

Mean Difference (IV, Random, 95% CI)

2.10 [0.56, 3.64]

3.3 Prostatron (Prostasoft 2.0): 3/6 months follow‐up

2

168

Mean Difference (IV, Random, 95% CI)

1.94 [‐1.29, 5.16]

3.4 Dornier Urowave: 6 months follow‐up

1

195

Mean Difference (IV, Random, 95% CI)

0.90 [‐0.45, 2.25]

3.5 Urologix Targis system: 6 months follow‐up

1

132

Mean Difference (IV, Random, 95% CI)

2.0 [0.14, 3.86]

4 Hematuria (post‐procedure) Show forest plot

4

684

Risk Difference (M‐H, Fixed, 95% CI)

0.07 [0.01, 0.13]

Analysis 2.4

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 4 Hematuria (post‐procedure).

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 4 Hematuria (post‐procedure).

5 Urinary retention Show forest plot

7

812

Risk Ratio (M‐H, Fixed, 95% CI)

6.04 [2.51, 14.52]

Analysis 2.5

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 5 Urinary retention.

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 5 Urinary retention.

6 Dysuria (self‐limited) Show forest plot

2

403

Risk Ratio (M‐H, Fixed, 95% CI)

2.06 [1.03, 4.13]

Analysis 2.6

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 6 Dysuria (self‐limited).

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 6 Dysuria (self‐limited).

7 UTI/epididymitis Show forest plot

3

486

Risk Ratio (M‐H, Fixed, 95% CI)

1.29 [0.70, 2.39]

Analysis 2.7

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 7 UTI/epididymitis.

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 7 UTI/epididymitis.

8 Ejaculatory disorders Show forest plot

2

389

Risk Ratio (M‐H, Fixed, 95% CI)

6.10 [0.83, 45.08]

Analysis 2.8

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 8 Ejaculatory disorders.

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 8 Ejaculatory disorders.

9 Retreatment Show forest plot

2

209

Risk Ratio (M‐H, Fixed, 95% CI)

0.12 [0.03, 0.48]

Analysis 2.9

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 9 Retreatment.

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 9 Retreatment.

10 Quality of Life Show forest plot

2

347

Mean Difference (IV, Fixed, 95% CI)

‐0.95 [‐1.14, ‐0.77]

Analysis 2.10

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 10 Quality of Life.

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 10 Quality of Life.

11 Bladder spasm Show forest plot

3

443

Risk Ratio (M‐H, Fixed, 95% CI)

1.02 [0.71, 1.47]

Analysis 2.11

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 11 Bladder spasm.

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 11 Bladder spasm.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 1

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

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 1 International Prostate Symptom Score (IPSS): 6 mos ‐ 1 year follow‐up.
Figuras y tablas -
Analysis 1.1

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 1 International Prostate Symptom Score (IPSS): 6 mos ‐ 1 year follow‐up.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 2 Madsen‐Iversen Symptom Score (range 0 to 27): 6 mos ‐ 1 year follow‐up.
Figuras y tablas -
Analysis 1.2

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 2 Madsen‐Iversen Symptom Score (range 0 to 27): 6 mos ‐ 1 year follow‐up.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 3 50% Improvement in AUA Symptom Score: # subjects.
Figuras y tablas -
Analysis 1.3

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 3 50% Improvement in AUA Symptom Score: # subjects.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 4 Peak Flow Rate (Qmax): 6 mos ‐ 1 year follow‐up.
Figuras y tablas -
Analysis 1.4

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 4 Peak Flow Rate (Qmax): 6 mos ‐ 1 year follow‐up.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 5 Hematuria (requiring additional treatment/judged to be serious).
Figuras y tablas -
Analysis 1.5

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 5 Hematuria (requiring additional treatment/judged to be serious).

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 6 Urinary retention.
Figuras y tablas -
Analysis 1.6

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 6 Urinary retention.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 7 Dysuria/Urgency.
Figuras y tablas -
Analysis 1.7

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 7 Dysuria/Urgency.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 8 Urinary tract infections/epididymitis/orchitis.
Figuras y tablas -
Analysis 1.8

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 8 Urinary tract infections/epididymitis/orchitis.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 9 Retrograde ejaculation (sexually active men only).
Figuras y tablas -
Analysis 1.9

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 9 Retrograde ejaculation (sexually active men only).

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 10 Erectile dysfunction.
Figuras y tablas -
Analysis 1.10

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 10 Erectile dysfunction.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 11 Repeat treatments/Reoperations up to 1 year.
Figuras y tablas -
Analysis 1.11

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 11 Repeat treatments/Reoperations up to 1 year.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 12 Urethral/bladder neck strictures.
Figuras y tablas -
Analysis 1.12

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 12 Urethral/bladder neck strictures.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 13 Transfusions.
Figuras y tablas -
Analysis 1.13

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 13 Transfusions.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 14 Clot retention.
Figuras y tablas -
Analysis 1.14

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 14 Clot retention.

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 15 TURP Syndrome.
Figuras y tablas -
Analysis 1.15

Comparison 1 Microwave thermotherapy versus transurethral resection of the prostate (TURP), Outcome 15 TURP Syndrome.

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 1 International Prostate Symptom Score (IPSS).
Figuras y tablas -
Analysis 2.1

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 1 International Prostate Symptom Score (IPSS).

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 2 Madsen Symptom Score.
Figuras y tablas -
Analysis 2.2

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 2 Madsen Symptom Score.

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 3 Peak Flow Rate (Qmax).
Figuras y tablas -
Analysis 2.3

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 3 Peak Flow Rate (Qmax).

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 4 Hematuria (post‐procedure).
Figuras y tablas -
Analysis 2.4

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 4 Hematuria (post‐procedure).

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 5 Urinary retention.
Figuras y tablas -
Analysis 2.5

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 5 Urinary retention.

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 6 Dysuria (self‐limited).
Figuras y tablas -
Analysis 2.6

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 6 Dysuria (self‐limited).

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 7 UTI/epididymitis.
Figuras y tablas -
Analysis 2.7

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 7 UTI/epididymitis.

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 8 Ejaculatory disorders.
Figuras y tablas -
Analysis 2.8

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 8 Ejaculatory disorders.

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 9 Retreatment.
Figuras y tablas -
Analysis 2.9

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 9 Retreatment.

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 10 Quality of Life.
Figuras y tablas -
Analysis 2.10

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 10 Quality of Life.

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 11 Bladder spasm.
Figuras y tablas -
Analysis 2.11

Comparison 2 Microwave thermotherapy versus sham treatment, Outcome 11 Bladder spasm.

Transurethral microwave thermotherapy (TUMT) compared with transurethral resection of the prostate (TURP) for symptomatic benign prostatic hyperplasia

Patient or population: men with symptomatic benign prostatic hyperplasia

Settings: office (TUMT) or hospital (TURP)

Intervention: Transurethral microwave thermotherapy (TUMT)

Comparison: Transurethral resection of the prostate (TURP)

Outcomes

Illustrative comparative risks* (95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Assumed risk

Corresponding risk

TURP

TUMT

International Prostate Symptom Score (IPSS).

Range: 0 to 35 points.

Follow‐up: 6 mos ‐ 1 year

The mean IPSS scores ranged across control groups from 3.4 to 7.1 points

The mean IPSS in the intervention group was 1 point higher (95% CI, 0.03 lower to 2.03 higher)

306
(studies)

⊕⊕⊕⊝
moderate1

Madsen‐Iversen Symptom Score Range 0 to 27 points

Follow‐up: 6 mos ‐ 1 year

The mean Madsen‐Iversen Symptom scores ranged across control groups from 0.62 to 2.7 points

The mean Madsen‐Iversen Symptom score in the intervention group was 1.59 points higher (95% CI, 0.69 lower to 2.48 higher)

338
(5 studies)

⊕⊕⊕⊝
moderate1

Peak Flow Rate (Qmax):

Measurement: mL per second

Follow‐up: 6 mos ‐ 1 year

The mean Peak Flow Rate ranged across control groups from 14.6 to 20.6 mL/s

The mean urinary peak flow rate in the intervention group was 5.08 mL/s lower (95% CI, 3.88 to 6.28 lower)

108
(2 studies)

⊕⊕⊕⊝
moderate1

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk Ratio.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 <400 subjects evaluated for this outcome which is a non‐optimal information size

Figuras y tablas -
Comparison 1. Microwave thermotherapy versus transurethral resection of the prostate (TURP)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 International Prostate Symptom Score (IPSS): 6 mos ‐ 1 year follow‐up Show forest plot

4

306

Mean Difference (IV, Random, 95% CI)

1.00 [‐2.03, 0.03]

1.1 ProstaLund Feedback Treatment

1

136

Mean Difference (IV, Random, 95% CI)

‐0.10 [‐2.44, 2.24]

1.2 Prostatron (high‐energy Prostasoft 2.5)

2

104

Mean Difference (IV, Random, 95% CI)

‐0.95 [‐2.40, 0.51]

1.3 Prostatron (Prostasoft 2.0 and 2.5)

1

66

Mean Difference (IV, Random, 95% CI)

‐2.7 [‐5.87, 0.47]

2 Madsen‐Iversen Symptom Score (range 0 to 27): 6 mos ‐ 1 year follow‐up Show forest plot

2

108

Mean Difference (IV, Fixed, 95% CI)

1.59 [0.69, 2.48]

2.1 Prostatron (high‐energy Prostasoft 2.5)

1

44

Mean Difference (IV, Fixed, 95% CI)

1.5 [‐1.07, 4.07]

2.2 Prostatron (low‐energy Prostasoft 2.0)

1

64

Mean Difference (IV, Fixed, 95% CI)

1.6 [0.64, 2.56]

3 50% Improvement in AUA Symptom Score: # subjects Show forest plot

2

121

Risk Ratio (M‐H, Random, 95% CI)

0.74 [0.50, 1.09]

4 Peak Flow Rate (Qmax): 6 mos ‐ 1 year follow‐up Show forest plot

5

338

Mean Difference (IV, Fixed, 95% CI)

5.08 [3.88, 6.28]

4.1 ProstaLund Feedback Treatment

1

104

Mean Difference (IV, Fixed, 95% CI)

1.90 [‐1.17, 4.97]

4.2 Prostatron (high‐energy Prostasoft 2.5)

2

104

Mean Difference (IV, Fixed, 95% CI)

5.26 [3.67, 6.85]

4.3 Prostatron (low‐energy Prostasoft 2.0)

1

64

Mean Difference (IV, Fixed, 95% CI)

6.30 [3.80, 8.80]

4.4 Prostatron (Prostasoft 2.0 and 2.5)

1

66

Mean Difference (IV, Fixed, 95% CI)

7.40 [1.68, 13.12]

5 Hematuria (requiring additional treatment/judged to be serious) Show forest plot

3

258

Risk Difference (M‐H, Random, 95% CI)

‐0.05 [‐0.15, 0.05]

6 Urinary retention Show forest plot

4

343

Risk Ratio (M‐H, Fixed, 95% CI)

2.94 [1.52, 5.70]

7 Dysuria/Urgency Show forest plot

3

277

Risk Ratio (M‐H, Fixed, 95% CI)

2.22 [1.28, 3.86]

8 Urinary tract infections/epididymitis/orchitis Show forest plot

5

395

Risk Ratio (M‐H, Fixed, 95% CI)

1.15 [0.70, 1.86]

9 Retrograde ejaculation (sexually active men only) Show forest plot

2

78

Risk Difference (M‐H, Fixed, 95% CI)

‐0.34 [‐0.55, ‐0.13]

10 Erectile dysfunction Show forest plot

3

212

Risk Ratio (M‐H, Fixed, 95% CI)

0.41 [0.16, 1.05]

11 Repeat treatments/Reoperations up to 1 year Show forest plot

4

335

Risk Ratio (M‐H, Fixed, 95% CI)

1.76 [0.54, 5.70]

12 Urethral/bladder neck strictures Show forest plot

3

197

Risk Ratio (M‐H, Fixed, 95% CI)

0.13 [0.02, 0.71]

13 Transfusions Show forest plot

2

128

Risk Difference (M‐H, Fixed, 95% CI)

‐0.11 [‐0.21, ‐0.02]

14 Clot retention Show forest plot

3

283

Risk Ratio (M‐H, Fixed, 95% CI)

0.27 [0.06, 1.31]

15 TURP Syndrome Show forest plot

3

274

Risk Difference (M‐H, Fixed, 95% CI)

‐0.05 [‐0.11, ‐0.00]

Figuras y tablas -
Comparison 1. Microwave thermotherapy versus transurethral resection of the prostate (TURP)
Comparison 2. Microwave thermotherapy versus sham treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 International Prostate Symptom Score (IPSS) Show forest plot

4

482

Mean Difference (IV, Fixed, 95% CI)

‐5.15 [‐6.04, ‐4.26]

1.1 LEO Microthermer: 3 months follow‐up

1

40

Mean Difference (IV, Fixed, 95% CI)

‐9.1 [‐15.64, ‐2.56]

1.2 Prostatron (Prostasoft 2.0): 3/6 months follow‐up

1

94

Mean Difference (IV, Fixed, 95% CI)

‐5.0 [‐8.09, ‐1.91]

1.3 Dornier Urowave: 6 months follow‐up

1

193

Mean Difference (IV, Fixed, 95% CI)

‐5.30 [‐6.32, ‐4.28]

1.4 Urologix Targis system: 6 months follow‐up

1

155

Mean Difference (IV, Fixed, 95% CI)

‐3.80 [‐6.26, ‐1.34]

2 Madsen Symptom Score Show forest plot

2

196

Mean Difference (IV, Fixed, 95% CI)

‐5.10 [‐6.42, ‐3.79]

2.1 Prostatron (Prostasoft): 3 months follow‐up

1

108

Mean Difference (IV, Fixed, 95% CI)

‐4.50 [‐6.37, ‐2.63]

2.2 Prostatron (Prostasoft 2.0): 3 months follow‐up

1

88

Mean Difference (IV, Fixed, 95% CI)

‐5.7 [‐7.56, ‐3.84]

3 Peak Flow Rate (Qmax) Show forest plot

6

643

Mean Difference (IV, Random, 95% CI)

2.01 [0.85, 3.16]

3.1 LEO Microthermer: 3 months follow‐up

1

40

Mean Difference (IV, Random, 95% CI)

4.80 [1.98, 7.62]

3.2 Prostatron (Prostasoft): 3 months follow‐up

1

108

Mean Difference (IV, Random, 95% CI)

2.10 [0.56, 3.64]

3.3 Prostatron (Prostasoft 2.0): 3/6 months follow‐up

2

168

Mean Difference (IV, Random, 95% CI)

1.94 [‐1.29, 5.16]

3.4 Dornier Urowave: 6 months follow‐up

1

195

Mean Difference (IV, Random, 95% CI)

0.90 [‐0.45, 2.25]

3.5 Urologix Targis system: 6 months follow‐up

1

132

Mean Difference (IV, Random, 95% CI)

2.0 [0.14, 3.86]

4 Hematuria (post‐procedure) Show forest plot

4

684

Risk Difference (M‐H, Fixed, 95% CI)

0.07 [0.01, 0.13]

5 Urinary retention Show forest plot

7

812

Risk Ratio (M‐H, Fixed, 95% CI)

6.04 [2.51, 14.52]

6 Dysuria (self‐limited) Show forest plot

2

403

Risk Ratio (M‐H, Fixed, 95% CI)

2.06 [1.03, 4.13]

7 UTI/epididymitis Show forest plot

3

486

Risk Ratio (M‐H, Fixed, 95% CI)

1.29 [0.70, 2.39]

8 Ejaculatory disorders Show forest plot

2

389

Risk Ratio (M‐H, Fixed, 95% CI)

6.10 [0.83, 45.08]

9 Retreatment Show forest plot

2

209

Risk Ratio (M‐H, Fixed, 95% CI)

0.12 [0.03, 0.48]

10 Quality of Life Show forest plot

2

347

Mean Difference (IV, Fixed, 95% CI)

‐0.95 [‐1.14, ‐0.77]

11 Bladder spasm Show forest plot

3

443

Risk Ratio (M‐H, Fixed, 95% CI)

1.02 [0.71, 1.47]

Figuras y tablas -
Comparison 2. Microwave thermotherapy versus sham treatment