Outcomes of a noninferiority randomised controlled trial of surgery for men with urodynamic stress incontinence after prostate surgery (MASTER)

Abrams, Paul; Constable, Lynda D.; Cooper, David; MacLennan, Graeme; Drake, Marcus J.; Harding, Chris; Mundy, Anthony; McCormack, Kirsty; McDonald, Alison; Norrie, John; Ramsay, Craig; Smith, Rebecca; Cotterill, Nikki; Kilonzo, Mary; Glazener, Cathryn

Abstract

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], 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.

• Journal Article Type: Article
• Acceptance Date: Jan 17, 2021
• Online Publication Date: Feb 4, 2021
• Publication Date: 2021-06
• Deposit Date: Feb 9, 2021
• Publicly Available Date: Jul 6, 2021
• Journal: European Urology
• Print ISSN: 0302-2838
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 79
• Issue: 6
• Pages: 812-823
• DOI: https://doi.org/10.1016/j.eururo.2021.01.024
• Keywords: Urology, urinary incontinence, prostate surgery, outcomes
• Public URL: https://uwe-repository.worktribe.com/output/7075962