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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)

Lookup NU author(s): Dr Sonya Carnell, Dr Jing Shen, Professor Elaine McColl, Dr Matthew Breckons, Professor Luke Vale, Dr Paul Whybrow, Professor Tim Rapley, Rebecca Forbes, Stephanie Currer, Dr Jennifer Wilkinson, Rob Pickard

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Abstract

© 2020There was no evidence of a difference regarding voiding symptoms in men with recurrent bulbar urethral stricture randomised to urethrotomy or urethroplasty. However, men allocated to urethroplasty had fewer reinterventions than those allocated to urethrotomy.© 2020Background: Urethral stricture affects 0.9% of men. Initial treatment is urethrotomy. Approximately, half of the strictures recur within 4 yr. Options for further treatment are repeat urethrotomy or open urethroplasty. Objective: To compare the effectiveness and cost-effectiveness of urethrotomy with open urethroplasty in adult men with recurrent bulbar urethral stricture. Design, setting, and participants: This was an open label, two-arm, patient-randomised controlled trial. UK National Health Service hospitals were recruited and 222 men were randomised to receive urethroplasty or urethrotomy. Intervention: 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. Outcome measurements and statistical analysis: The primary outcome was the profile over 24 mo of a patient-reported outcome measure, the voiding symptom score. The main clinical outcome was time until reintervention. Results and limitations: The primary analysis included 69 (63%) and 90 (81%) of those allocated to urethroplasty and urethrotomy, respectively. The mean difference between the urethroplasty and urethrotomy groups was –0.36 (95% confidence interval [CI] –1.74 to 1.02). Fifteen men allocated to urethroplasty needed a reintervention compared with 29 allocated to urethrotomy (hazard ratio [95% CI] 0.52 [0.31–0.89]). Conclusions: 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 the following two treatment options: urethrotomy and urethroplasty. At the end of the study, both treatments resulted in similar and better symptom scores. However, the urethroplasty group had fewer reinterventions.


Publication metadata

Author(s): Goulao B, Carnell S, Shen J, MacLennan G, Norrie J, Cook J, McColl E, Breckons M, Vale L, Whybrow P, Rapley T, Forbes R, Currer S, Forrest M, Wilkinson J, Andrich D, Barclay S, Mundy A, N'Dow J, Payne S, Watkin N, Pickard R

Publication type: Article

Publication status: Published

Journal: European Urology

Year: 2020

Volume: 78

Issue: 4

Pages: 572-580

Print publication date: 01/10/2020

Online publication date: 04/07/2020

Acceptance date: 02/06/2020

ISSN (print): 0302-2838

ISSN (electronic): 1873-7560

Publisher: Elsevier BV

URL: https://doi.org/10.1016/j.eururo.2020.06.003

DOI: 10.1016/j.eururo.2020.06.003


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