Surgical Treatment for Recurrent Bulbar Urethral Stricture: A Randomised Open-label Superiority Trial of Open Urethroplasty Versus Endoscopic Urethrotomy (the OPEN Trial)

Goulão, Beatriz; Carnell, Sonya; Shen, Jing; MacLennan, Graeme; Norrie, John; Cook, Jonathan; McColl, Elaine; Breckons, Matthew; Vale, Luke; Whybrow, Paul; Rapley, Tim; Forbes, Rebecca; Currer, Stephanie; Forrest, Mark; Wilkinson, Jennifer; Andrich, Daniela E.; Barclay, Stewart; Mundy, Anthony R.; N’Dow, James; Payne, S. R.; Watkin, Nick; Pickard, Robert

doi:10.1016/j.eururo.2020.06.003

Cited by 26 publications

(42 citation statements)

References 17 publications

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“…36,37 This concept has recently been challenged by the OPEN trial, the first randomised controlled trial comparing endoscopic intervention with urethroplasty for recurrent bulbar urethral strictures. 38 This trial has shown both interventions have comparable short-term outcomes, in terms of symptom control, however as expected, patients undergoing urethroplasty had a lower re-intervention rate over two years (16 v. 28%). These rates of re-intervention over the short period of follow-up in this trial, and the relatively high cost of urethroplasty meant that, at least in the UK, urethroplasty had only a 14% chance of being cost-effective for the treatment of recurrent bulbar strictures by comparison with DVIU.…”

Section: Resultssupporting

confidence: 52%

The standard for the management of male urethral strictures in the UK: a consensus document

Bugeja

Payne

Eardley

et al. 2020

Journal of Clinical Urology

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Objective: The aim of this study was to establish an evidence-based best clinical practice consensus for the management of urethral stricture disease in the UK. Methods: A systematic review of optimal management of urethral stricture generated a base document which was endorsed by the British Association of Urological Surgeons (BAUS) section of Andrology and Genito-Urinary Reconstructive Surgeons (AGUS). A two-round electronic mail modified Delphi survey of 43 consultant reconstructive urologists, members of the British Association of Genito-Urinary Reconstructive Surgeons (BAGURS), was then performed. The panel’s views about the base document was sought in seven domains: definition, diagnosis, investigation, conservative, endoscopic and reconstructive treatments, and follow up. Responses were collated and used to modify the base to achieve a consensus statement. Results: In round one of the Delphi process four panel members commented on the base document and seven in round two. Consensus was thereby reached on 38 statements regarding definition (one), diagnosis (three), investigation (two), conservative/endoscopic (five) and reconstructive (24) treatments and follow up (three) for the management of urethral stricture disease. Conclusion: This consensus statement will help standardise care, provide guidance on the management of urethral stricture disease, and assist in clinical decision-making for healthcare professionals of all grades.

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Section: Resultssupporting

confidence: 52%

The standard for the management of male urethral strictures in the UK: a consensus document

Bugeja

Payne

Eardley

et al. 2020

Journal of Clinical Urology

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“…The algorithm allocated participants to each intervention in a 1:1 ratio with recruitment site and time since last procedure (< 12 months or ≥ 12 months) as minimisation covariates. Trial procedures and statistical analysis are described elsewhere [6,9]. The OPEN trial's economic analysis comprised a within trial cost-effectiveness analysis and Markov model with a 10-year time horizon.…”

Section: Methodsmentioning

confidence: 99%

“…QALYs were based on responses to the EQ-5D-5L collected at baseline, immediately prior to surgery, 1 week after catheter removal, 3,6,9,12,24 months following surgery, 18 and 24 months after randomisation and at the end of study. The responses to the EQ-5D-5L questionnaire were scored using UK population tariffs [19] to produce a health state utility score for each participant in each of the treatment groups using the area under the curve (AUC) method [20].…”

Section: Quality-adjusted Life Yearsmentioning

confidence: 99%

“…Given the large number of time points for EQ-5D-5L data and to align with the primary effectiveness analysis [9], it was decided that to be included in the AUC analysis as a complete case, the participant must have at least three EQ-5D-5L observations with one at the start of the assessment period, one at the mid-range and one at the end. The speci c requirements depended on whether the participants had an initial intervention and the type of analysis conducted (details in the supplementary material).…”

Section: Quality-adjusted Life Yearsmentioning

confidence: 99%

“…To address this evidence gap, a randomised controlled trial (RCT) was conducted to compare the clinical and cost-effectiveness of urethroplasty versus endoscopic urethrotomy for the alleviation of urinary symptoms in men with recurrent bulbar stricture over 24 months (the OPEN (open urethroplasty versus endoscopic urethrotomy) Trial [6]). Clinical results of the OPEN trial are presented elsewhere [9]. This paper presents the cost-effectiveness analysis results.…”

Section: Introductionmentioning

confidence: 99%

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Endoscopic Urethrotomy Vs Open Urethroplasty for Men With Bulbar Urethral Stricture: The Open Randomised Trial Cost-Effectiveness Analysis 

Shen

Vale

Goulão

et al. 2021

Preprint

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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-effectiveness. 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-effectiveness 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. 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. Results: In 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.Conclusions: Based on current practice and evidence, urethrotomy is a cost-effective treatment compared with urethroplasty. Trial registration: ISRCTN: 98009168 (date: 29 November 2012) and it is also in the UK NIHR Portfolio (reference 13507).

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Economic evaluation of Optilume, a drug‐coated balloon for recurrent anterior male urethral stricture

Kelly

Shore

Wright³

et al. 2023

BJUI Compass

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Objectives: We aim to conduct an economic evaluation of the Optilume urethral drug-coated balloon (DCB) compared with endoscopic management for the treatment of recurrent anterior male urethral stricture in England.Patients and Methods: A cohort Markov model was developed to estimate the costs and savings to the NHS over a 5-year time horizon of adopting Optilume for the treatment of anterior urethral male stricture versus current endoscopic standard of care. A scenario analysis was conducted which compared Optilume to urethroplasty.Probabilistic and deterministic sensitivity analyses were performed to estimate the impact of uncertainties in model parameters.Results: When compared with current endoscopic standard of care Optilume resulted in an estimated cost saving of £2502 per patient if introduced in the NHS for the treatment of recurrent anterior male urethral stricture. In the scenario analysis, the use of Optilume compared with urethroplasty resulted in an estimated cost saving of £243. Results were robust to changes in individual input parameters as demonstrated in the deterministic sensitivity analyses, with the monthly probability of symptom recurrence associated with endoscopic management the only exception.Probabilistic sensitivity analysis results demonstrated that Optilume was cost saving in 93.4% of model iterations, when running 1000 iterations. Conclusion:Our analysis suggests that the Optilume urethral DCB treatment can be a cost-saving alternative management option for the treatment of recurrent anterior male urethral stricture within the NHS in England.

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Surgical Treatment for Recurrent Bulbar Urethral Stricture: A Randomised Open-label Superiority Trial of Open Urethroplasty Versus Endoscopic Urethrotomy (the OPEN Trial)

Cited by 26 publications

References 17 publications

The standard for the management of male urethral strictures in the UK: a consensus document

The standard for the management of male urethral strictures in the UK: a consensus document

Endoscopic Urethrotomy Vs Open Urethroplasty for Men With Bulbar Urethral Stricture: The Open Randomised Trial Cost-Effectiveness Analysis

Economic evaluation of Optilume, a drug‐coated balloon for recurrent anterior male urethral stricture

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Surgical Treatment for Recurrent Bulbar Urethral Stricture: A Randomised Open-label Superiority Trial of Open Urethroplasty Versus Endoscopic Urethrotomy (the OPEN Trial)

Cited by 26 publications

References 17 publications

The standard for the management of male urethral strictures in the UK: a consensus document

The standard for the management of male urethral strictures in the UK: a consensus document

Endoscopic Urethrotomy Vs Open Urethroplasty for Men With Bulbar Urethral Stricture: The Open Randomised Trial Cost-Effectiveness Analysis&nbsp;

Economic evaluation of Optilume, a drug‐coated balloon for recurrent anterior male urethral stricture

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Endoscopic Urethrotomy Vs Open Urethroplasty for Men With Bulbar Urethral Stricture: The Open Randomised Trial Cost-Effectiveness Analysis