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Outcomes of a Noninferiority Randomised Controlled Trial of Surgery for Men with Urodynamic Stress Incontinence After Prostate Surgery (MASTER)

Lookup NU author(s): Marcus Drake, Christopher Harding

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Abstract

© 2021 The AuthorsBackground: 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], pNI = 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.© 2021 The AuthorsThe results of this large, high-quality trial allow surgeons to discuss and recommend the use of both the artificial sphincter and the sling procedure for postprostatectomy incontinence, as the results with respect to urine leakage were similar. However, men will wish to know that the majority will have some persistent urinary incontinence, although satisfaction with surgery was high: in the artificial urinary sphincter (AUS) group 91% and 85% were, respectively, completely and fairly satisfied, and 85% would recommend an AUS to a friend; and in the sling group, 72% were completely or fairly satisfied and 72% would recommend a sling to a friend. Similarly, most of the other secondary outcomes favoured the AUS over the sling procedure.


Publication metadata

Author(s): Abrams P, Constable LD, Cooper D, MacLennan G, Drake MJ, Harding C, Mundy A, McCormack K, McDonald A, Norrie J, Ramsay C, Smith R, Cotterill N, Kilonzo M, Glazener C

Publication type: Article

Publication status: Published

Journal: European Urology

Year: 2021

Pages: epub ahead of print

Online publication date: 04/02/2021

Acceptance date: 17/01/2021

ISSN (print): 0302-2838

ISSN (electronic): 1873-7560

Publisher: Elsevier B.V.

URL: https://doi.org/10.1016/j.eururo.2021.01.024

DOI: 10.1016/j.eururo.2021.01.024


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