Male synthetic sling versus Artificial urinary Sphincter Trial for men with urodynamic stress incontinence after prostate surgery: Evaluation by Randomised controlled trial (MASTER).

A pragmatic multicentre randomised controlled non-inferiority trial comparing the effectiveness of the synthetic sling (‘male sling’) with the artificial urinary sphincter (AUS) for men with urodynamic stress incontinence (USI) after prostate surgery (radical prostatectomy or transurethral resection of the prostate; TURP). Health technologies being assessed: Both interventions involve the surgical implantation of a prosthetic device designed to restore continence by specialist urological surgeons. The trial will take place within designated NHS hospitals with the appropriate expertise to implant either the male sling or the AUS. Surgical procedures and other operative variables will be standardised by using agreed protocols. The male sling is a strip of plastic mesh that is placed under the urethra through an incision under the scrotum with each end passed through the obturator foramen into the upper thigh. It is then tensioned to elevate and partially compress the urethra. It is designed to be effective immediately although maximum benefit may take a few weeks to develop. The AUS is a three-part device. A fluid filled plastic cuff is placed circumferentially around the urethra which is accessed through an incision under the scrotum. The cuff is then connected by internalised plastic tubing to firstly a fluid filled pressure-regulating balloon and secondly a small mechanical pump. The balloon is placed in the retropubic space and the pump in a sub-cutaneous pocket in the scrotum. After implantation, the device is initially deactivated with the cuff empty. The man then returns to hospital typically four to six weeks after surgery for activation. He then has to learn how to operate the device. This requires three squeezes of the control pump in the scrotum to empty the cuff and allow voiding. The cuff then automatically refills over 2-3 minutes to restore continence. Setting: All surgeons carrying out AUS or male sling implantation in the UK have agreed to take part. This encompasses 23 centres: Belfast; Birmingham, Bristol; Cambridge; Cardiff; Chichester; Edinburgh; Glasgow; Leicester; Liverpool/Southport; London (2); Manchester; Middlesbrough; Newcastle, Norwich; Oxford; Salisbury; Sheffield; Stockport; Swansea; Wakefield; and Wrexham. We are confident that the trial can recruit to target exclusively in the UK. However, the applicants have collaborations with colleagues throughout Europe, particularly in Belgium and The Netherlands and the protocol would be made available for their participation if agreed and separately funded. Target population: Men with urodynamic stress incontinence (USI) after prostate surgery (radical prostatectomy or TURP), for whom surgery is judged appropriate following discussion of options between patient and clinician. For the purposes of the trial we will define men with mild incontinence as those not requiring surgery. There is no clear threshold for defining moderate or severe incontinence and little evidence of differential benefit for either intervention according to incontinence severity. We will therefore include all men whose degree of incontinence is sufficient to require surgery, from both the patient and surgeon perspectives. Measurement of costs and outcomes: The primary outcome on which non-inferiority will be judged will be participant’s report of urinary incontinence at 12 months measured by a response indicating any loss of urine to either of the two questions: “How often do you leak urine?” and “How much urine do you leak?” in the validated ICIQ-Short Form questionnaire. Twelve months was chosen since maximum benefit of the implantation device is likely to have accrued and any harms directly related to the peri-operative period will have occurred and been resolved. The primary economic outcome will be incremental cost per quality-adjusted life-year (QALY) measured using the EQ-5D at 24 months to allow for the possible need for re-interventio