Presentation Authors: Watkin Nick*, London, United Kingdom, Beatriz Goulao, Aberdeen, United Kingdom, Sonya Carnell, Shen Jing, Newcastle, United Kingdom, Graeme MacLennan, John Norrie, Aberdeen, United Kingdom, Jonathan Cook, Oxford, United Kingdom, Elaine McColl, Matthew Breckons, Luke Vale, Rebecca Forbes, Stephanie Currer, Newcastle, United Kingdom, Mark Forrest, Aberdeen, United Kingdom, Jennifer Wilkinson, Newcastle, United Kingdom, Daniela Andrich, London, United Kingdom, Stewart Barclay, Newcastle, United Kingdom, Anthony Munday, London, United Kingdom, James N'Dow, Aberdeen, United Kingdom, Steve Payne, Manchester, United Kingdom, Robert Pickard, Newcastle, United Kingdom
Introduction: Peno-bulbar urethral stricture disease affects around 0.5% of men. Initial treatment is typically urethrotomy, widening the narrowed area internally by incision using an endoscope-mounted blade. Recurrence within four years will occur in about half of the subjects. Options for further treatment are repeat urethrotomy or reconstruction of the urethra by open urethroplasty. The OPEN Trial sought to estimate the relative benefits of these two interventions.
Methods: A 24-month trial randomly assigned men from 38 UK NHS hospitals between 27/02/2013 and 23/12/2015 to open urethroplasty or endoscopic urethrotomy 1:1 by a remote system with permuted blocks of variable length. Trial staff recording outcomes were masked to allocation, whilst participants, clinicians and local research staff were not masked. Primary outcome was the area under the curve (AUC) of repeated measurements of a previously validated Patient Reported Outcome Measure (PROM) voiding symptom score. 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 of follow-up were included in the primary complete-case intention to treat analysis. The main secondary outcome was need for re-intervention. ISRCTN: 98009168.
Results: The primary analysis included 69 (63%) of those allocated to urethroplasty and 90 (81%) of those 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 a 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).
Conclusions: 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.
Source of Funding: NIHR Health Technology Assessment Programme