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

Goulao, Beatriz, Carnell, Sonya, Shen, Jing, MacLennan, Graeme, Norrie, John, Cook, Jonathan, McColl, Elaine, Breckons, Matt, Vale, Luke, Whybrow, Paul, Rapley, Tim, Forbes, Rebecca, Currer, Stephanie, Forrest, Mark, Wilkinson, Jennifer, Andrich, Daniela, Barclay, Stewart, Mundy, Anthony, N’Dow, James, Payne, Stephen, Watkin, Nick and Pickard, Robert (2020) Surgical Treatment for Recurrent Bulbar Urethral Stricture: A Randomised Open-label Superiority Trial of Open Urethroplasty Versus Endoscopic Urethrotomy (the OPEN Trial). European Urology, 78 (4). pp. 572-580. ISSN 0302-2838

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Abstract

Background:
Urethral stricture affects 0.9% of men. Initial treatment is urethrotomy. Approximately, half of the strictures recur within four years. Options for further treatment are repeat urethrotomy or open urethroplasty.
Objectives:
To compare the effectiveness and cost-effectiveness of urethrotomy with open urethroplasty in adult men with recurrent bulbar urethral stricture.
Design, Setting and Participants
Open label, two-arm, patient randomised controlled trial. UK NHS hospitals were recruited and randomised 222 men to urethroplasty or urethrotomy.
Interventions:
Urethrotomy is a minimally invasive technique whereby the narrowed area is progressively widened by cutting the scar tissue with a steel blade mounted on a urethroscope. Urethroplasty is a more invasive surgery to reconstruct the narrowed area.
Main outcome measures:
The primary outcome was the profile over 24 months of a patient-reported outcome measure, the ICIQ voiding symptom score. The main clinical outcome was time until re-intervention.
Results:
The primary analysis included 69 (63%) and 90 (81%) of those allocated to urethroplasty and urethrotomy respectively. The mean difference between urethroplasty and urethrotomy group was -0.36 (95% confidence interval - CI (-1.74 to 1.02)). Fifteen men allocated to urethroplasty needed a re-intervention compared to 29 allocated to urethrotomy, hazard ratio (95% CI) 0.52 (0.31 to 0.89).
Conclusion:
In men with recurrent bulbar urethral stricture both urethroplasty and urethrotomy improved voiding symptoms. The benefit lasted longer for urethroplasty.
Patient summary:
There was uncertainty about the best treatment for men with recurrent bulbar urethral stricture. We randomised men to receive one of two treatment options: urethrotomy or urethroplasty. At the end of the study, both treatments resulted in similar and better symptom scores. However, the urethroplasty group had fewer re-interventions.

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