PMID- 33551297 OWN - NLM STAT- MEDLINE DCOM- 20220214 LR - 20231115 IS - 1873-7560 (Electronic) IS - 0302-2838 (Print) IS - 0302-2838 (Linking) VI - 79 IP - 6 DP - 2021 Jun TI - Outcomes of a Noninferiority Randomised Controlled Trial of Surgery for Men with Urodynamic Stress Incontinence After Prostate Surgery (MASTER). PG - 812-823 LID - S0302-2838(21)00063-4 [pii] LID - 10.1016/j.eururo.2021.01.024 [doi] AB - BACKGROUND: Stress urinary incontinence (SUI) is common after radical prostatectomy and likely to persist despite conservative treatment. The sling is an emerging operation for persistent SUI, but randomised controlled trial (RCT) comparison with the established artificial urinary sphincter (AUS) is lacking. OBJECTIVE: To compare the outcomes of surgery in men with bothersome urodynamic SUI after prostate surgery. DESIGN, SETTING, AND PARTICIPANTS: A noninferiority RCT was conducted among men with bothersome urodynamic SUI from 27 UK centres. Blinding was not possible due the surgeries. INTERVENTION: Participants were randomly assigned (1:1) to the male transobturator sling (n = 190) or the AUS (n = 190) group. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was patient-reported SUI 12 mo after randomisation, collected from postal questionnaire using a composite outcome from two items in validated International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form questionnaire (ICIQ-UI SF). Noninferiority margin was 15%, thought to be of acceptable lower effectiveness, in return for reduced adverse events (AEs) and easier operation, for the sling. Secondary outcomes were operative and postoperative details, patient-reported measures, and AEs, up to 12 mo after surgery. RESULTS AND LIMITATIONS: A total of 380 participants were included. At 12 mo after randomisation, incontinence rates were 134/154 (87.0%) for male sling versus 133/158 (84.2%) for AUS (difference 3.6% [95% confidence interval CI -11.6 to 4.6], p(NI) = 0.003), showing noninferiority. Incontinence symptoms (ICIQ-UI SF) reduced from scores of 16.1 and 16.4 at baseline to 8.7 and 7.5 for male sling and AUS, respectively (mean difference 1.4 [95% CI 0.2-2.6], p = 0.02). Serious AEs (SAEs) were few: n = 6 and n = 13 for male sling and AUS (one man had three SAEs), respectively. Quality of life scores improved, and satisfaction was high in both groups. All other secondary outcomes that show statistically significant differences favour the AUS. CONCLUSIONS: Using a strict definition, urinary incontinence rates remained high, with no evidence of difference between male sling and AUS. Symptoms and quality of life improved significantly in both groups, and men were generally satisfied with both procedures. Overall, secondary and post hoc analyses were in favour of AUS. PATIENT SUMMARY: Urinary incontinence after prostatectomy has considerable effect on men's quality of life. MASTER shows that if surgery is needed, both surgical options result in fewer symptoms and high satisfaction, despite most men not being completely dry. However, most other results indicate that men having an artificial urinary sphincter have better outcomes than those who have a sling. CI - Copyright (c) 2021 The Authors. Published by Elsevier B.V. All rights reserved. FAU - Abrams, Paul AU - Abrams P AD - Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust, Bristol, UK. FAU - Constable, Lynda D AU - Constable LD AD - Health Services Research Unit (HSRU), University of Aberdeen, Aberdeen, UK. Electronic address: l.constable@abdn.ac.uk. FAU - Cooper, David AU - Cooper D AD - Health Services Research Unit (HSRU), University of Aberdeen, Aberdeen, UK. FAU - MacLennan, Graeme AU - MacLennan G AD - Health Services Research Unit (HSRU), University of Aberdeen, Aberdeen, UK. FAU - Drake, Marcus J AU - Drake MJ AD - Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust, Bristol, UK; School of Physiology, Pharmacology and Neuroscience, University of Bristol, Bristol, UK. FAU - Harding, Chris AU - Harding C AD - Department of Urology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK; Translational and Clinical Research Institute, Newcastle University, Newcastle, UK. FAU - Mundy, Anthony AU - Mundy A AD - Department of Urology, University College London Hospitals NHS Foundation Trust, London, UK. FAU - McCormack, Kirsty AU - McCormack K AD - Health Services Research Unit (HSRU), University of Aberdeen, Aberdeen, UK. FAU - McDonald, Alison AU - McDonald A AD - Health Services Research Unit (HSRU), University of Aberdeen, Aberdeen, UK. FAU - Norrie, John AU - Norrie J AD - Usher Institute, College of Medicine and Veterinary Medicine, University of Edinburgh, Edinburgh, UK. FAU - Ramsay, Craig AU - Ramsay C AD - Health Services Research Unit (HSRU), University of Aberdeen, Aberdeen, UK. FAU - Smith, Rebecca AU - Smith R AD - Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust, Bristol, UK. FAU - Cotterill, Nikki AU - Cotterill N AD - Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust, Bristol, UK; Faculty of Health and Applied Science, University of West of England, Bristol, UK. FAU - Kilonzo, Mary AU - Kilonzo M AD - Health Economics Research Unit, University of Aberdeen, Aberdeen, UK. FAU - Glazener, Cathryn AU - Glazener C AD - Health Services Research Unit (HSRU), University of Aberdeen, Aberdeen, UK. CN - MASTER Trial Team LA - eng GR - HERU1/CSO_/Chief Scientist Office/United Kingdom GR - HSRU1/CSO_/Chief Scientist Office/United Kingdom GR - 11/106/01/DH_/Department of Health/United Kingdom PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20210204 PL - Switzerland TA - Eur Urol JT - European urology JID - 7512719 SB - IM CIN - Eur Urol. 2021 Jun;79(6):824-825. PMID: 33581874 CIN - Eur Urol. 2021 Jun;79(6):e178-e179. PMID: 33795177 CIN - Eur Urol. 2021 Jun;79(6):e180-e181. PMID: 33812726 CIN - Eur Urol. 2021 Aug;80(2):e59-e60. PMID: 34006444 CIN - Aktuelle Urol. 2022 Feb;53(1):12. PMID: 35078253 CIN - J Urol. 2022 Oct;208(4):923-924. PMID: 35914315 MH - Humans MH - Male MH - Prostate MH - *Suburethral Slings/adverse effects MH - Treatment Outcome MH - *Urinary Incontinence MH - *Urinary Incontinence, Stress/diagnosis/surgery MH - Urodynamics PMC - PMC8175331 OTO - NOTNLM OT - Artificial urinary sphincter OT - Male sling OT - Noninferiority OT - Randomised controlled trial OT - Urodynamic stress incontinence EDAT- 2021/02/09 06:00 MHDA- 2022/02/15 06:00 PMCR- 2021/06/01 CRDT- 2021/02/08 05:30 PHST- 2020/10/19 00:00 [received] PHST- 2021/01/17 00:00 [accepted] PHST- 2021/02/09 06:00 [pubmed] PHST- 2022/02/15 06:00 [medline] PHST- 2021/02/08 05:30 [entrez] PHST- 2021/06/01 00:00 [pmc-release] AID - S0302-2838(21)00063-4 [pii] AID - 10.1016/j.eururo.2021.01.024 [doi] PST - ppublish SO - Eur Urol. 2021 Jun;79(6):812-823. doi: 10.1016/j.eururo.2021.01.024. Epub 2021 Feb 4.