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Outcomes of a noninferiority randomised controlled trial of surgery for men with urodynamic stress incontinence after prostate surgery (MASTER)

Abrams, Paul; Constable, Lynda D.; Cooper, David; MacLennan, Graeme; Drake, Marcus J.; Harding, Chris; Mundy, Anthony; McCormack, Kirsty; McDonald, Alison; Norrie, John; Ramsay, Craig; Smith, Rebecca; Cotterill, Nikki; Kilonzo, Mary; Glazener, Cathryn

Outcomes of a noninferiority randomised controlled trial of surgery for men with urodynamic stress incontinence after prostate surgery (MASTER) Thumbnail


Authors

Paul Abrams

Lynda D. Constable

David Cooper

Graeme MacLennan

Marcus J. Drake

Chris Harding

Anthony Mundy

Kirsty McCormack

Alison McDonald

John Norrie

Craig Ramsay

Rebecca Smith

N Nikki Cotterill Nikki.Cotterill@uwe.ac.uk
Associate Professor on Long Term Conditions (Continence Care)

Mary Kilonzo

Cathryn Glazener



Abstract

Background
Stress urinary incontinence (SUI) is common after radical prostatectomy and likely to persist despite conservative treatment. The sling is an emerging operation for persistent SUI, but randomised controlled trial (RCT) comparison with the established artificial urinary sphincter (AUS) is lacking.

Objective
To compare the outcomes of surgery in men with bothersome urodynamic SUI after prostate surgery.

Design, setting, and participants
A noninferiority RCT was conducted among men with bothersome urodynamic SUI from 27 UK centres. Blinding was not possible due the surgeries.

Intervention
Participants were randomly assigned (1:1) to the male transobturator sling (n = 190) or the AUS (n = 190) group.

Outcome measurements and statistical analysis
The primary outcome was patient-reported SUI 12 mo after randomisation, collected from postal questionnaire using a composite outcome from two items in validated International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form questionnaire (ICIQ-UI SF). Noninferiority margin was 15%, thought to be of acceptable lower effectiveness, in return for reduced adverse events (AEs) and easier operation, for the sling. Secondary outcomes were operative and postoperative details, patient-reported measures, and AEs, up to 12 mo after surgery.

Results and limitations
A total of 380 participants were included. At 12 mo after randomisation, incontinence rates were 134/154 (87.0%) for male sling versus 133/158 (84.2%) for AUS (difference 3.6% [95% confidence interval {CI} –11.6 to 4.6], pNI = 0.003), showing noninferiority. Incontinence symptoms (ICIQ-UI SF) reduced from scores of 16.1 and 16.4 at baseline to 8.7 and 7.5 for male sling and AUS, respectively (mean difference 1.4 [95% CI 0.2–2.6], p = 0.02). Serious AEs (SAEs) were few: n = 6 and n = 13 for male sling and AUS (one man had three SAEs), respectively. Quality of life scores improved, and satisfaction was high in both groups. All other secondary outcomes that show statistically significant differences favour the AUS.

Conclusions
Using a strict definition, urinary incontinence rates remained high, with no evidence of difference between male sling and AUS. Symptoms and quality of life improved significantly in both groups, and men were generally satisfied with both procedures. Overall, secondary and post hoc analyses were in favour of AUS.

Patient summary
Urinary incontinence after prostatectomy has considerable effect on men’s quality of life. 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 an artificial urinary sphincter have better outcomes than those who have a sling.

Citation

Abrams, P., Constable, L. D., Cooper, D., MacLennan, G., Drake, M. J., Harding, C., …Glazener, C. (2021). Outcomes of a noninferiority randomised controlled trial of surgery for men with urodynamic stress incontinence after prostate surgery (MASTER). European Urology, 79(6), 812-823. https://doi.org/10.1016/j.eururo.2021.01.024

Journal Article Type Article
Acceptance Date Jan 17, 2021
Online Publication Date Feb 4, 2021
Publication Date 2021-06
Deposit Date Feb 9, 2021
Publicly Available Date Jul 6, 2021
Journal European Urology
Print ISSN 0302-2838
Electronic ISSN 1873-7560
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 79
Issue 6
Pages 812-823
DOI https://doi.org/10.1016/j.eururo.2021.01.024
Keywords Urology, urinary incontinence, prostate surgery, outcomes
Public URL https://uwe-repository.worktribe.com/output/7075962

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