Surgical treatment for recurrent bulbar urethral stricture: A randomised open label superiority trial of open urethroplasty versus endoscopic urethrotomy (The OPEN Trial).
BAUS ePoster online library. Watkin N. 06/24/19; 259538; P4-9
Nick Watkin
Nick Watkin
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Peno-bulbar urethral stricture disease affects 0.5% of men. Initial treatment is typically urethrotomy. Recurrence within four years occurs in about half of subjects. Options for further treatment are repeat urethrotomy or by urethroplasty. The OPEN Trial sought to estimate the relative benefits of these two interventions.


A 24-month trial (2013-15) randomly assigned men from 38 UK hospitals to urethroplasty or urethrotomy. Primary outcome was the area under the curve (AUC) of measurements of a previously validated Patient Reported Outcome Measure (PROM). Participants who completed at least three scores: one prior to intervention, one in the first year of follow-up and one during the second year were included in the primary intention to treat analysis. The main secondary outcome was need for re-intervention.


The primary analysis included 69 (63%) allocated to urethroplasty and 90 (81%) allocated to urethrotomy. The mean (SD) AUC of voiding score at 24-months on a scale from 0 (no symptoms) to 24 (worst symptoms) was 7.4 (3.8) in the urethroplasty group and 7.8 (4.2) in the urethrotomy group, a mean (95% CI) difference of -0.36 (-1.74 to 1.02). Fifteen (16%) men in the urethroplasty group required re-intervention compared to 29 (28%) of men allocated to urethrotomy. The hazard ratio for time until first re-intervention (95% CI) was 0.52 (0.31 to 0.89).


In men with recurrent peno-bulbar urethral stricture, both urethroplasty and urethrotomy provided effective control of voiding symptoms. The benefit lasted longer, and the need for re-intervention lower in those allocated to urethroplasty.
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