Endoscopic urethrotomy versus open urethroplasty for men with bulbar urethral stricture: the OPEN randomised trial cost-effectiveness analysis
Authors: Shen Jing , Vale Luke , Goulao Beatriz , Whybrow Paul , Payne Stephen , Watkin Nick ,   OPEN trial investigators, Dorkin Trevor , Watkin Nick , Mundy Anthony , Anderson Paul , Venn Suzie , Eardley Ian , Dickerson David , Thiruchelvam Nikesh , Inman Richard , Chapple Chris , Baird Andrew , Sinclair Andrew , Krishnanm Rajeshwar , Rees Rowland , N’dow James , Montgomery Bruce , Swinn Michael , Henderson Alastair , Donohue John , Venn Suzie , Mason Robert , Madaan Sanjeev , Hilmy Mustafa , Kirchin Vivienne , Davenport Kim , McGrath John , Porter Tim , MacDonagh Ruaraidh , Birring Amerdip , Ravi Ramachandran , Husain Jawad , Shabbir Maj , Baldo Omer , Chitale Sadhanshu , Garthwaite Mary , Srirangam Shalom , Chowoo Liaqat , Rashid Tina , Skyrme Rob , Featherstone Jon , Alhasso Ammar , Tatarov Oleg 
Published: May 2021

AbstractBackgroundBulbar 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-effectiveness. Current guidelines on the management of recurrent bulbar urethral stricture have been predominantly based on expert opinion and panel consensus.ObjectiveTo assess the relative cost-effectiveness of open urethroplasty and endoscopic urethrotomy as treatment for recurrent urethral stricture in men.MethodsSet 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. 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 months using a within trial analysis and a Markov model with a 10-year time horizon.ResultsIn the within trial, urethroplasty cost on average more than urethrotomy (cost difference: £2148 [95% CI 689, 3606]) and resulted in a similar number of QALYs on average (QALY difference: − 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.ConclusionsBased on current practice and evidence, urethrotomy is a cost-effective treatment compared with urethroplasty.KeypointsUrethrotomy 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 offer good value for money compared to urethrotomy based on current evidence.Trial registration: ISRCTN: 98009168 (date: 29 November 2012) and it is also in the UK NIHR Portfolio (reference 13507).Trial protocol: The latest version (1.8) of the full protocol is available at:www.journalslibrary.nihr.ac.uk/programmes/hta/105723/#/ 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—clarifying the management of men with recurrent urethral stricture (the OPEN trial): study protocol for a randomised controlled trial. Trials 2015;16:600.https://doi.org/10.1186/s13063-015-1120-4.Trial main clinical results publication: 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 572–580.