Endoscopic urethrotomy versus open urethroplasty for men with bulbar urethral stricture: the OPEN randomised trial cost-effectiveness analysis

Shen, Jing; Vale, Luke; Goulao, Beatriz; Whybrow, Paul; Payne, Stephen; Watkin, Nick; OPEN trial investigators

Abstract

Abstract
Background: Bulbar urethral stricture is a common cause for urinary symptoms in men and its two main treatment options both have drawbacks with little evidence on their relative cost-efectiveness. Current guidelines on
the management of recurrent bulbar urethral stricture have been predominantly based on expert opinion and panel
consensus.
Objective: To assess the relative cost-efectiveness of open urethroplasty and endoscopic urethrotomy as treatment
for recurrent urethral stricture in men.
Methods: Set in the UK National Health Service with recruitment from 38 hospital sites, a randomised controlled trial
of open urethroplasty and endoscopic urethrotomy with 6-monthly follow-up over 24 months was conducted. Two
hundred and twenty-two men requiring operative treatment for recurrence of bulbar urethral stricture and having
had at least one previous intervention for stricture were recruited. Efectiveness was measured by quality- adjusted life
years (QALYs) derived from EQ-5D 5L. Cost-efectiveness was measured by the incremental cost per QALY gained over
24 months using a within trial analysis and a Markov model with a 10-year time horizon.
Results: In the within trial, urethroplasty cost on average more than urethrotomy (cost diference: £2148 [95% CI
689, 3606]) and resulted in a similar number of QALYs on average (QALY diference: − 0.01 [95% CI − 0.17, 0.14)] over
24 months. The Markov model produced similar results. Sensitivity analyses using multiple imputation, suggested that
the results were robust, despite observed missing data.
Conclusions: Based on current practice and evidence, urethrotomy is a cost-efective treatment compared with
urethroplasty.
Keypoints: Urethrotomy and urethroplasty both led to symptom improvement for men with bulbar urethral stricture—a common cause for urinary symptoms in men; Urethroplasty appeared unlikely to ofer good value for money
compared to urethrotomy based on current evidence.

Citation

Shen, J., Vale, L., Goulao, B., Whybrow, P., Payne, S., Watkin, N., & OPEN trial investigators. (2021). Endoscopic urethrotomy versus open urethroplasty for men with bulbar urethral stricture: the OPEN randomised trial cost-effectiveness analysis. BMC Urology, 21(1), Article 76. https://doi.org/10.1186/s12894-021-00836-1

• Journal Article Type: Article
• Acceptance Date: Apr 12, 2021
• Online Publication Date: May 3, 2021
• Publication Date: 2021-12
• Deposit Date: May 3, 2022
• Publicly Available Date: May 5, 2022
• Journal: BMC Urology
• Print ISSN: 1471-2490
• Publisher: BioMed Central
• Peer Reviewed: Peer Reviewed
• Volume: 21
• Issue: 1
• Article Number: 76
• DOI: https://doi.org/10.1186/s12894-021-00836-1
• Keywords: Cost-effectiveness; Economic model; Randomised controlled trial; Urethral stricture; Urethroplasty; Urethrotomy
• Public URL: https://hull-repository.worktribe.com/output/3778196
• Additional Information: The study was conducted in line with all relevant guidelines and regulations for the conduct of a randomised controlled trial. The underlying study design was approved by the funder (UK NIHR HTA programme) in the original funding application. The detailed study protocol was approved by the Trial Steering Committee (comprising an independent clinician who acted as chairperson, two further independent clinicians, an independent statistician, a lay representative and the Chief Investigator). In addition the economic evaluation reported in this paper complied with the CHEERS checklist for the reporting of an economic evaluation.; : The Newcastle upon Tyne Hospitals NHS Foundation Trust Research and Development Directorate sponsored the trial (Reference 6332). Favourable ethical opinion for the trial was obtained on 16th October 2012 from the NHS Research Ethics Service Committee North East—Newcastle and North Tyneside (Reference: 12/NE/0343) and subsequent Research and Development and Caldicott approvals were granted by each participating site.; : Study participants were consented at individual participating site following the procedure set out in the trail protocol. Trial information was provided and potential participants were given at least 48 h to consider participation in the study. Following review, at a mutually convenient time, those men who wanted to take part, who fulfilled the entry criteria and who understood the rationale and conduct of the trial, provided informed consent witnessed by research staff at site with delegated approval to do so. The right to refuse to participate without giving reasons was respected.