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
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
