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

Clark, L; Fitzgerald, B; Noble, Sian; MacNeill, Stephanie; Paramasivan, Sangeetha; Cotterill, Nikki; Hashim, Hashim; Jha, Swati; Toozs-Hobson, Phillip; Greenwell, T; Thiruchelvam, Nikesh; Agur, Wael; White, A; Garner, V; Cobos-Arrivabene, M; Clement, Clare; Cochrane, M; Liu, Y; Lewis, Amanda L; Taylor, J; Lane, J A; Drake, Marcus J; Pope, Caroline

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


Authors

L Clark

B Fitzgerald

Sian Noble

Stephanie MacNeill

Sangeetha Paramasivan

Profile image of Nikki Cotterill

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

Hashim Hashim

Swati Jha

Phillip Toozs-Hobson

T Greenwell

Nikesh Thiruchelvam

Wael Agur

A White

V Garner

M Cobos-Arrivabene

Clare Clement

M Cochrane

Y Liu

Amanda L Lewis

J Taylor

J A Lane

Marcus J Drake

Caroline Pope



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.

Journal Article Type Article
Acceptance Date Jul 13, 2022
Online Publication Date Aug 3, 2022
Publication Date Aug 3, 2022
Deposit Date Jul 19, 2022
Publicly Available Date Sep 4, 2022
Journal Trials
Print ISSN 1745-6215
Publisher BioMed Central
Peer Reviewed Peer Reviewed
Volume 23
Issue 1
Article Number 628
DOI https://doi.org/10.1186/s13063-022-06546-9
Keywords PURSUIT; Recurrent Stress Urinary Incontinence; Endoscopic Bulking Injections; Surgery; Colposuspension; Autologous Fascial Sling; Artificial Urinary Sphincter; Randomised Controlled Trial; International Consultation on Incontinence Questionnaire – Urin
Public URL https://uwe-repository.worktribe.com/output/9711106
Publisher URL https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06546-9

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Proper understanding of recurrent stress urinary incontinence treatment in women (PURSUIT): A randomised controlled trial of endoscopic and surgical treatment (1.9 Mb)
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Copyright Statement
© The Author(s) 2022. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.








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