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

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.

Metadata

Item Type:	Article
Authors/Creators:	Clark, L. Fitzgerald, B. Noble, S. MacNeill, S. Paramasivan, S. Cotterill, N. Hashim, H. Jha, S. https://orcid.org/0000-0002-4519-6903 Toozs-Hobson, P. Greenwell, T. Thiruchelvam, N. Agur, W. White, A. Garner, V. Cobos-Arrivabene, M. Clement, C. Cochrane, M. Liu, Y. Lewis, A.L. Taylor, J. Lane, J.A. Drake, M.J. Pope, C.
Copyright, Publisher and Additional Information:	© 2022 The Author(s). Open Access. 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://creativeco mmons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
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 – Urinary Incontinence – Short Form (ICIQ-UI-SF); Qualitative
Dates:	Published: 3 August 2022 Published (online): 3 August 2022 Accepted: 13 July 2022
Institution:	The University of Sheffield
Academic Units:	The University of Sheffield > Sheffield Teaching Hospitals
Depositing User:	Symplectic Sheffield
Date Deposited:	11 Aug 2022 09:35
Last Modified:	11 Aug 2022 09:35
Status:	Published
Publisher:	BioMed Central (part of Springer Nature)
Refereed:	Yes
Identification Number:	10.1186/s13063-022-06546-9
Open Archives Initiative ID (OAI ID):	oai:eprints.whiterose.ac.uk:189908

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

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