Male synthetic sling versus Artificial urinary Sphincter Trial for men with urodynamic stress incontinence after prostate surgery

Conditions

Adult men with urodynamic stress incontinence after prostate surgery Urological and Genital Diseases Stress incontinence

Constable L, Drake MJ, Cooper D, MacLennan G, Harding C, Mundy A, McCormack K, Norrie J, Ramsay C, Smith R, Cotterill N, Kilonzo M, Abrams P, MASTER trial team.

2026-08-26

10.1016/j.euf.2026.07.012

Synthetic sling or artificial urinary sphincter for men with urodynamic stress incontinence after prostate surgery: the MASTER non-inferiority RCT

Lynda Constable, Paul Abrams, David Cooper, Mary Kilonzo, Nikki Cotterill et al. (17 authors)

Health Technology Assessment2022-08-0115 citations

10.3310/tbfz0277

Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after prostate surgery (MASTER): study protocol for a randomised controlled trial.

Constable L, Cotterill N, Cooper D, Glazener C, Drake MJ, Forrest M, Harding C, Kilonzo M, MacLennan G, McCormack K, McDonald A, Mundy A, Norrie J, Pickard R, Ramsay C, Smith R, Wileman S, Abrams P, (Chief Investigator) for the MASTER Study Group.

2018-02-2119 citations

10.1186/s13063-018-2501-2

Interventions

Two surgical operations for male urinary incontinence, a synthetic male sling and an artificial urinary sphincter (AUS) implantation will be evaluated. All adult men who have decided in discussion wit

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Adult men who have decided in discussion with their urologist to have surgery for urodynamic stress incontinence (USI) resulting from prostate surgery.

Exclusion criteria

Exclusion criteria: 1. Men who have had previous male sling or AUS surgery. 2. Men with unresolved bladder neck contracture or urethral stricture after prostate surgery. 3. Men who do not consent to be randomised (these men will be asked to consent to follow up). 4. Men with insufficient manual dexterity to operate AUS device. 5. Men who are unable to give informed consent or complete trial documentation.

Design outcomes

Primary

Measure	Time frame
1. Clinical effectiveness of implantation of the male sling compared with AUS in terms of self-reported incontinence at 12 months. 2. Cost effectiveness of a policy of primary implantation of the male sling compared with AUS, measured by incremental cost per quality-adjusted life-year (QALY) at 24 months.	—

Secondary

Measure	Time frame
1. Risks of each type of surgery 2. Costs of the benefits and risks of each treatment policy 3. Subsequent NHS services (including repeat surgery) needed for men with persistent or recurrent problems 4. The differential effects of the operations on other outcomes such as quality of life and general health 5. Satisfaction of the men with each procedure	—

Countries

England, United Kingdom

Outcome results

None listed