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

Beatriz Goulao, Sonya Carnell, Jing Shen, Graeme MacLennan, John Norrie, Jonathan Cook, Elaine McColl, Matthew Breckons, Luke Vale* (Corresponding Author), Paul Whybrow, Tim Rapley, Rebecca Forbes, Stephanie Currer, Mark Forrest, Jennifer Wilkinson, Daniela Andrich, Stewart Barclay, Anthony Mundy, James N'Dow, Stephen PayneNick Watkin, Robert Pickard

*Corresponding author for this work

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Background:
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.
Original languageEnglish
Pages (from-to)572-580
Number of pages9
JournalEuropean Urology
Volume78
Issue number4
Early online date4 Jul 2020
DOIs
Publication statusE-pub ahead of print - 4 Jul 2020

Keywords

  • Surgery
  • Randmised controlled trial
  • Urethral stricture
  • Urethroplasty
  • Urethrotomy
  • Voiding sympstoms
  • Voiding symptoms
  • Randomised controlled trial

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    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., ... Pickard, R. (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), 572-580. https://doi.org/10.1016/j.eururo.2020.06.003