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
|Publication status||Accepted/In press - 17 Jan 2021|
- urodynamic stress incontinence
- male sling
- artificial urinary sphincter
- randomised controlled trial