Synthetic sling or artificial urinary sphincter for men with urodynamic stress incontinence after prostate surgery: the MASTER non-inferiority RCT
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Published version
Author(s)
Type
Journal Article
Abstract
Background Stress urinary incontinence is common in men after prostate surgery and can be difficult to improve. Implantation of an artificial urinary sphincter is the most common surgical procedure for persistent stress urinary incontinence, but it requires specialist surgical skills, and revisions may be necessary. In addition, the sphincter is relatively expensive and its operation requires adequate patient dexterity. New surgical approaches include the male synthetic sling, which is emerging as a possible alternative. However, robust comparable data, derived from randomised controlled trials, on the relative safety and efficacy of the male synthetic sling and the artificial urinary sphincter are lacking. Objective We aimed to compare the clinical effectiveness and cost-effectiveness of the male synthetic sling with those of the artificial urinary sphincter surgery in men with persistent stress urinary incontinence after prostate surgery. Design This was a multicentre, non-inferiority randomised controlled trial, with a parallel non-randomised cohort and embedded qualitative component. Randomised controlled trial allocation was carried out by remote web-based randomisation (1 : 1), minimised on previous prostate surgery (radical prostatectomy or transurethral resection of the prostate), radiotherapy (or not, in relation to prostate surgery) and centre. Surgeons and participants were not blind to the treatment received. Non-randomised cohort allocation was participant and/or surgeon preference. Setting The trial was set in 28 UK urological centres in the NHS. Participants Participants were men with urodynamic stress incontinence after prostate surgery for whom surgery was deemed appropriate. Exclusion criteria included previous sling or artificial urinary sphincter surgery, unresolved bladder neck contracture or urethral stricture after prostate surgery, and an inability to give informed consent or complete trial documentation. Interventions We compared male synthetic sling with artificial urinary sphincter.
Date Issued
2022-08
Online Publication Date
2023-02-16T09:21:37Z
Date Acceptance
2022-08-01
ISSN
1366-5278
Publisher
National Institute for Health and Care Research (NIHR)
Start Page
1
End Page
152
Journal / Book Title
Health Technology Assessment
Volume
26
Issue
36
Copyright Statement
Copyright © 2022 Constable et al. This work was produced by Constable et al. under the terms of a commissioning contract
issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of
the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaption
in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/.
For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication
must be cited.
issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of
the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaption
in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/.
For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication
must be cited.
License URI
Identifier
https://www.journalslibrary.nihr.ac.uk/hta/TBFZ0277#/abstract
Publication Status
Published
Date Publish Online
2022-08