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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Colposuspension | Study protocol

Proper understanding of recurrent stress urinary incontinence treatment in women (PURSUIT): a randomised controlled trial of endoscopic and surgical treatment

Authors: L. Clark, B. Fitzgerald, S. Noble, S. MacNeill, S. Paramasivan, N. Cotterill, H. Hashim, S. Jha, P. Toozs-Hobson, T. Greenwell, N. Thiruchelvam, W. Agur, A. White, V. Garner, M. Cobos-Arrivabene, C. Clement, M. Cochrane, Y. Liu, A. L. Lewis, J. Taylor, J. A. Lane, M. J. Drake, C. Pope

Published in: Trials | Issue 1/2022

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Abstract

Background

Women with stress urinary incontinence (SUI) experience urine leakage with physical activity. Currently, the interventional treatments for SUI are surgical, or endoscopic bulking injection(s). However, these procedures are not always successful, and symptoms can persist or come back after treatment, categorised as recurrent SUI. There are longstanding symptoms and distress associated with a failed primary treatment, and currently, there is no consensus on how best to treat women with recurrent, or persistent, SUI.

Methods

A two-arm trial, set in at least 20 National Health Service (NHS) urology and urogynaecology referral units in the UK, randomising 250 adult women with recurrent or persistent SUI 1:1 to receive either an endoscopic intervention (endoscopic bulking injections) or a standard NHS surgical intervention, currently colposuspension, autologous fascial sling or artificial urinary sphincter. The aim of the trial is to determine whether surgical treatment is superior to endoscopic bulking injections in terms of symptom severity at 1 year after randomisation. This primary outcome will be measured using the patient-reported International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI-SF). Secondary outcomes include assessment of longer-term clinical impact, improvement of symptoms, safety, operative assessments, sexual function, cost-effectiveness and an evaluation of patients’ and clinicians’ views and experiences of the interventions.

Discussion

There is a lack of high-quality, randomised, scientific evidence for which treatment is best for women presenting with recurrent SUI. The PURSUIT study will benefit healthcare professionals and patients and provide robust evidence to guide further treatment and improve symptoms and quality of life for women with this condition.

Trial registration

International Standard Randomised Controlled Trials Number (ISRCTN) registry ISRCTN12201059. Registered on 09 January 2020
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Metadata
Title
Proper understanding of recurrent stress urinary incontinence treatment in women (PURSUIT): a randomised controlled trial of endoscopic and surgical treatment
Authors
L. Clark
B. Fitzgerald
S. Noble
S. MacNeill
S. Paramasivan
N. Cotterill
H. Hashim
S. Jha
P. Toozs-Hobson
T. Greenwell
N. Thiruchelvam
W. Agur
A. White
V. Garner
M. Cobos-Arrivabene
C. Clement
M. Cochrane
Y. Liu
A. L. Lewis
J. Taylor
J. A. Lane
M. J. Drake
C. Pope
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06546-9

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