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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, Lynda; Cotterill, Nikki; Cooper, David; Glazener, Cathryn; Drake, Marcus J; Forrest, Mark; Harding, Chris; Kilonzo, Mary; MacLennan, Graeme; McCormack, Kirsty; McDonald, Alison; Mundy, Anthony; Norrie, John; Pickard, Robert; Ramsay, Craig; Smith, Rebecca; Wileman, Samantha; Abrams, Paul


Lynda Constable

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N Nikki Cotterill
Professor of Long Term Conditions (Continence Care)

David Cooper

Cathryn Glazener

Marcus J Drake

Mark Forrest

Chris Harding

Mary Kilonzo

Graeme MacLennan

Kirsty McCormack

Alison McDonald

Anthony Mundy

John Norrie

Robert Pickard

Craig Ramsay

Rebecca Smith

Samantha Wileman

Paul Abrams


© 2018 The Author(s). Background: Stress urinary incontinence (SUI) is a frequent adverse effect for men undergoing prostate surgery. A large proportion (around 8% after radical prostatectomy and 2% after transurethral resection of prostate (TURP)) are left with severe disabling incontinence which adversely effects their quality of life and many are reliant on containment measures such as pads (27% and 6% respectively). Surgery is currently the only option for active management of the problem. The overwhelming majority of surgeries for persistent bothersome SUI involve artificial urinary sphincter (AUS) insertion. However, this is expensive, and necessitates manipulation of a pump to enable voiding. More recently, an alternative to AUS has been developed - a synthetic sling for men which elevates the urethra, thus treating SUI. This is thought, by some, to be less invasive, more acceptable and less expensive than AUS but clear evidence for this is lacking. The MASTER trial aims to determine whether the male synthetic sling is non-inferior to implantation of the AUS for men who have SUI after prostate surgery (for cancer or benign disease), judged primarily on clinical effectiveness but also considering relative harms and cost-effectiveness. Methods/design: Men with urodynamic stress incontinence (USI) after prostate surgery, for whom surgery is judged appropriate, are the target population. We aim to recruit men from secondary care urological centres in the UK NHS who carry out surgery for post-prostatectomy incontinence. Outcomes will be assessed by participant-completed questionnaires and 3-day urinary bladder diaries at baseline, 6, 12 and 24 months. The 24-h urinary pad test will be used at baseline as an objective assessment of urine loss. Clinical data will be completed at the time of surgery to provide details of the operative procedures, complications and resource use in hospital. At 12 months, men will also have a clinical review to evaluate the results of surgery (including another 24-h pad test) and to identify problems or need for further treatment. Discussion: A robust examination of the comparative effectiveness of the male synthetic sling will provide high-quality evidence to determine whether or not it should be adopted widely in the NHS.


Constable, L., Cotterill, N., Cooper, D., Glazener, C., Drake, M. J., Forrest, M., …Abrams, P. (2018). 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. Trials, 19(1),

Journal Article Type Article
Acceptance Date Feb 22, 2018
Online Publication Date Feb 21, 2018
Publication Date Feb 21, 2018
Journal Trials
Print ISSN 1745-6215
Electronic ISSN 1745-6215
Publisher BMC
Peer Reviewed Peer Reviewed
Volume 19
Issue 1
Keywords urinary incontinence, male sling, artificial urinary sphincter, randomised controlled trial
Public URL
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