Authors' objectives: Recurrence or persistence of symptoms after interventions to treat stress urinary incontinence in women is common, but without robust evidence to base treatment recommendations. To investigate whether endoscopic or surgical treatments for stress urinary incontinence in women are effective and cost-effective.

Authors' results and conclusions: Fifty-five women were deemed eligible after screening (n = 328 screened) from October 2019 to June 2022. Twenty-four eligible women consented, and 23 were randomised (between January 2020 and July 2022) from 8 sites with the average age of 57 years (standard deviation: 10.7) and all self-reported ‘white’ ethnicity. Participants reported a median International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form score at baseline of 16 (interquartile range: 13–19) and mean post-void residual volume of 4.64 ml (standard deviation: 8.45). Eleven participants received their allocated intervention, 2 participants withdrew prior to receiving their intervention and 10 were waiting for their intervention when the study closed. The most common reason for declining participation was a treatment preference (n = 14). Recruitment training sessions and recruitment tips documents were developed and implemented to address challenges centred around patient treatment preferences and clinicians’ equipoise. However, the most important recruitment challenge was the low number of eligible patients, driven primarily by the COVID-19 pandemic preventing referrals and surgery, and related wider issues in the National Health Service which led to study closure in January 2023. In its early stages, the initial recruitment rate was on target (four participants randomised in the first 3 months of recruitment), but once the pandemic started, the study was unable to recruit and so closed early. The main limitation was the occurrence of the global pandemic soon after the commencement of recruitment, profoundly affecting service delivery and patient presentations. Under normal healthcare service conditions, the study may be deliverable.

Authors' methods: A multicentre, unblinded, parallel-group randomised controlled trial. Fifteen centres across the United Kingdom. Adult women with recurrent or persistent stress urinary incontinence. Failure to recruit under pandemic conditions rendered the study unfeasible.

Authors' identified further research: Practical experience with the study and development of patient-facing and staff training materials will help delivery of the study once patient referrals and healthcare services fully return to normal.

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/17/95/03

Year Published: 2025

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/published-articles/AKAK8992

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: England, United Kingdom

DOI: 10.3310/AKAK8992

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk