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

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

doi:10.1186/s13063-022-06546-9

Trials (Aug 2022)

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

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

Affiliations

L. Clark: Department of Population Health Sciences, Bristol Medical School, University of Bristol
B. Fitzgerald: Department of Population Health Sciences, Bristol Medical School, University of Bristol
S. Noble: Department of Population Health Sciences, Bristol Medical School, University of Bristol
S. MacNeill: Department of Population Health Sciences, Bristol Medical School, University of Bristol
S. Paramasivan: Department of Population Health Sciences, Bristol Medical School, University of Bristol
N. Cotterill: Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust
H. Hashim: Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust
S. Jha: Department of Urogynaecology, Sheffield Teaching Hospitals NHS Foundation Trust
P. Toozs-Hobson: Department of Urogynaecology, Birmingham Women’s & Children’s Hospital NHS Foundation Trust
T. Greenwell: Department of Urology, University College London Hospital
N. Thiruchelvam: Department of Urology, Cambridge University Hospitals NHS Trust
W. Agur: Department of Obstetrics and Gynaecology, NHS Ayrshire and Arran, University Hospital Crosshouse
A. White: Patient and Public Involvement (PPI) Representative
V. Garner: Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust
M. Cobos-Arrivabene: Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust
C. Clement: Bristol Trials Centre (BTC), University of Bristol
M. Cochrane: Department of Population Health Sciences, Bristol Medical School, University of Bristol
Y. Liu: Department of Population Health Sciences, Bristol Medical School, University of Bristol
A. L. Lewis: Department of Population Health Sciences, Bristol Medical School, University of Bristol
J. Taylor: Department of Population Health Sciences, Bristol Medical School, University of Bristol
J. A. Lane: Department of Population Health Sciences, Bristol Medical School, University of Bristol
M. J. Drake: Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust
C. Pope: Department of Population Health Sciences, Bristol Medical School, University of Bristol

DOI: https://doi.org/10.1186/s13063-022-06546-9
Journal volume & issue: Vol. 23, no. 1
pp. 1 – 23

Abstract

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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

Published in Trials

ISSN: 1745-6215 (Online)
Publisher: BMC
Country of publisher: United Kingdom
LCC subjects: Medicine: Medicine (General)
Website: https://trialsjournal.biomedcentral.com

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