Beatriz Goulao1, Sonya Carnell2, Jing Shen3, Graeme MacLennan4, John Norrie5, Jonathan Cook6, Elaine McColl3, Matt Breckons3, Luke Vale7, Paul Whybrow8, Tim Rapley9, Rebecca Forbes2, Stephanie Currer2, Mark Forrest4, Jennifer Wilkinson2, Daniela Andrich10, Stewart Barclay11, Anthony Mundy10, James N'Dow12, Stephen Payne13, Nick Watkin14, Robert Pickard15. 1. Health Services Research Unit, University of Aberdeen, Aberdeen, UK. 2. Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK. 3. Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK. 4. Centre for Healthcare and Randomised Trials, University of Aberdeen, Aberdeen, UK. 5. Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK. 6. Centre for Statistics in Medicine, University of Oxford, Oxford, UK. 7. Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK. Electronic address: luke.vale@ncl.ac.uk. 8. Hull York Medical School, University of Hull, Hull, UK. 9. Social Work, Education and Community Wellbeing, University of Northumbria, Newcastle upon Tyne, UK. 10. University College London Hospital, London, UK. 11. Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK. 12. Academic Urology Unit, University of Aberdeen, Aberdeen, UK. 13. Central Manchester Hospitals NHS Foundation Trust, Manchester, UK. 14. St George's University Hospitals NHS Foundation Trust, London, UK. 15. Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.
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.
RCT Entities:
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.
Authors: Robert Pickard; Beatriz Goulao; Sonya Carnell; Jing Shen; Graeme MacLennan; John Norrie; Matt Breckons; Luke Vale; Paul Whybrow; Tim Rapley; Rebecca Forbes; Stephanie Currer; Mark Forrest; Jennifer Wilkinson; Elaine McColl; Daniela Andrich; Stewart Barclay; Jonathan Cook; Anthony Mundy; James N'Dow; Stephen Payne; Nick Watkin Journal: Health Technol Assess Date: 2020-11 Impact factor: 4.014
Authors: Hilin Yildirim; Pauline M L Hennus; Michel I A Wyndaele; Laetitia M O de Kort Journal: Low Urin Tract Symptoms Date: 2021-11-18 Impact factor: 1.374