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Current guidelines on the management of recurrent bulbar urethral stricture have been predominantly based on expert opinion and panel consensus.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To assess the relative cost-effectiveness of open urethroplasty and endoscopic urethrotomy as treatment for recurrent urethral stricture in men.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>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\u00a0months 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. Effectiveness was measured by quality- adjusted life years (QALYs) derived from EQ-5D 5L. Cost-effectiveness was measured by the incremental cost per QALY gained over 24\u00a0months using a within trial analysis and a Markov model with a 10-year time horizon.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In the within trial, urethroplasty cost on average more than urethrotomy (cost difference: \u00a32148 [95% CI 689, 3606]) and resulted in a similar number of QALYs on average (QALY difference: \u2212\u00a00.01 [95% CI \u2212\u00a00.17, 0.14)] over 24\u00a0months. The Markov model produced similar results. Sensitivity analyses using multiple imputation, suggested that the results were robust, despite observed missing data.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Based on current practice and evidence, urethrotomy is a cost-effective treatment compared with urethroplasty.<\/jats:p><\/jats:sec><jats:sec><jats:title>Keypoints<\/jats:title><jats:p>Urethrotomy and urethroplasty both led to symptom improvement for men with bulbar urethral stricture\u2014a common cause for urinary symptoms in men; Urethroplasty appeared unlikely to offer good value for money compared to urethrotomy based on current evidence.<\/jats:p><jats:p><jats:italic>Trial registration<\/jats:italic>: ISRCTN: 98009168 (date: 29 November 2012) and it is also in the UK NIHR Portfolio (reference 13507).<\/jats:p><jats:p><jats:italic>Trial protocol<\/jats:italic>: The latest version (1.8) of the full protocol is available at:<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.journalslibrary.nihr.ac.uk\/programmes\/hta\/105723\/\">www.journalslibrary.nihr.ac.uk\/programmes\/hta\/105723\/<\/jats:ext-link>#\/ and a published version is also available: Stephenson R, Carnell S, Johnson N, Brown R, Wilkinson J, Mundy A, et al. Open urethroplasty versus endoscopic urethrotomy\u2014clarifying the management of men with recurrent urethral stricture (the OPEN trial): study protocol for a randomised controlled trial. Trials 2015;16:600.<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/doi.org\/10.1186\/s13063-015-1120-4.\">https:\/\/doi.org\/10.1186\/s13063-015-1120-4.<\/jats:ext-link><\/jats:p><jats:p><jats:italic>Trial main clinical results publication<\/jats:italic>: Goulao B, Carnell S, Shen J, MacLennan G, Norrie J, Cook J, et al. Surgical Treatment for Recurrent Bulbar Urethral Stricture: A Randomised Open-label Superiority Trial of Open Urethroplasty Versus Endoscopic Urethrotomy (the OPEN Trial), European Urology, Volume 78, Issue 4, 2020, Pages 572\u2013580.<\/jats:p><\/jats:sec>","DOI":"10.1186\/s12894-021-00836-1","type":"journal-article","created":{"date-parts":[[2021,5,3]],"date-time":"2021-05-03T16:03:03Z","timestamp":1620057783000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Endoscopic urethrotomy versus open urethroplasty for men with bulbar urethral stricture: the OPEN randomised trial cost-effectiveness 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The underlying study design was approved by the funder (UK NIHR HTA programme) in the original funding application.\u00a0The 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.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Guidelines and regulations"}},{"value":"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\u2014Newcastle and North Tyneside (Reference: 12\/NE\/0343) and subsequent Research and Development and Caldicott approvals were granted by each participating site.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"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\u00a0h 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.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"All authors declare no competing interests.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"76"}}