Proper understanding of recurrent stress urinary incontinence treatment in women (PURSUIT): a randomised controlled trial of endoscopic and surgical treatment
Author(s)
Type
Journal Article
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.
Date Issued
2022-08-03
Date Acceptance
2022-07-13
Citation
Trials, 2022, 23 (1)
ISSN
1745-6215
Publisher
BMC
Journal / Book Title
Trials
Volume
23
Issue
1
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/35922823
PII: 10.1186/s13063-022-06546-9
Subjects
Adult
Female
Humans
Quality of Life
State Medicine
Treatment Outcome
Urinary Incontinence
Urinary Incontinence, Stress
Urinary Sphincter, Artificial
Artificial urinary sphincter
Autologous fascial sling
Colposuspension
Endoscopic bulking injections
International Consultation on Incontinence Questionnaire – Urinary Incontinence – Short Form (ICIQ-UI-SF)
PURSUIT
Qualitative
Randomised controlled trial
Recurrent stress urinary incontinence
Surgery
Publication Status
Published
Coverage Spatial
England
Article Number
ARTN 628