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

Paul Abrams, Lynda Constable* (Corresponding Author), David Cooper, Graeme MacLennan, Marcus J Drake, Chris Harding, Anthony Mundy, Kirsty McCormack, Alison McDonald, John Norrie, Craig Ramsay, Rebecca Smith, Nikki Cotterill, Mary Kilonzo, Cathryn Glazener, MASTER trial team

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

7 Citations (Scopus)

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: compare outcomes of surgery in men with bothersome urodynamic SUI after prostate surgery.
Design, settings and participants: Non-inferiority RCT of men with bothersome
urodynamic SUI; 27 UK centres. Blinding was not possible due the surgeries.
Interventions: Participants randomly assigned (1:1) to male transobturator sling (n=190) or AUS (n=190).
Outcome measures and statistical analysis: Primary outcome: patient-reported SUI, 12 months post randomisation (PR) from postal questionnaire using a composite outcome from two items in validated ICIQ-UI SF. Non-inferiority margin was 15%, thought to be an acceptable lower effectiveness, in return for reduced adverse events (AEs) and easier operation, for the sling. Secondary outcomes: operative and post-operative details, patient reported measures, and AEs, up to 12 months post-surgery.
Results and limitations: 380 participants. At 12 months PR, incontinence rates were 134/154 (87.0%) for male sling versus 133/158 (84.2%) for AUS (difference 3.6% (95% CI -11.6 to 4.6, pNI = 0.003)), showing non-inferiority. Incontinence symptoms (ICIQ-UI SF) reduced from scores of 16.1 and 16.4 at baseline to 8.7 and 7.5, male sling and AUS respectively (MD 1.4 (95% CI 0.2 to 2.6 p = 0.02). Serious AEs (SAEs) were few; n=6 and n=13 for male sling and AUS (one man had 3 SAEs), respectively. Quality of life scores improved, satisfaction was high in both groups. All other secondary outcomes that show statistically significant differences, favour the AUS.
Conclusions: Using a strict definition, UI rates remained high, with no evidence of difference between male sling and AUS. Symptoms and QoL significantly improved in both groups and men were generally satisfied with both procedures. Overall, secondary and post61 hoc analyses were in favour of AUS.
Patient summary: Urinary incontinence after prostatectomy has considerable effect on men’s QoL. 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 AUS have better outcomes than those who have a sling
Original languageEnglish
Pages (from-to)812-823
Number of pages11
JournalEuropean Urology
Volume79
Issue number6
Early online date4 Feb 2021
DOIs
Publication statusPublished - Jun 2021

Keywords

  • urodynamic stress incontinence
  • male sling
  • artificial urinary sphincter
  • randomised controlled trial
  • non-inferiority

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