Stress urinary incontinence (SUI) is common in men after prostate surgery (PS) and can be difficult to improve. Implantation with the artificial urinary sphincter (AUS) is the most common surgical procedure for persistent SUI but requires adequate patient dexterity to operate, specialist surgical skills, is relatively expensive and may require revisions over time. New surgical approaches include the male synthetic sling emerging as a possible alternative. However, robust comparable data on its safety and efficacy, derived from randomised controlled trials (RCT) in comparison with AUS is lacking.
To compare clinical and cost-effectiveness of male synthetic sling with AUS surgery in men with persistent SUI after PS.
A multi-centre, non-inferiority RCT with a parallel non-randomised cohort (NRC), and embedded qualitative component. RCT allocation was by remote web-based randomisation (1:1), minimised on previous PS (radical prostatectomy (RP) or transurethral resection of the prostate (TURP)), radiotherapy (or not, in relation to PS), and centre. Surgeons and participants were not blind to treatment received. NRC allocation was participant and/or surgeon preference.
- post-prostatectomy incontinence
- male incontinence
- artificial urinary sphincter
- male sling
- randomised controlled tria