Surgical treatment for recurrent bulbar urethral stricture: a randomised open-label superiority trial of open urethroplasty versus endoscopic urethrotomy (the OPEN Trial)
<p><strong>BACKGROUND:</strong> 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.</p> <p><strong&g...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
| Published: |
Elsevier
2020
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| _version_ | 1797055694534344704 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Goulao, B |
| collection | OXFORD |
| description | <p><strong>BACKGROUND:</strong> 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.</p>
<p><strong>OBJECTIVE:</strong> To compare the effectiveness and cost-effectiveness of urethrotomy with open urethroplasty in adult men with recurrent bulbar urethral stricture.</p>
<p><strong>DESIGN, SETTING, AND PARTICIPANTS:</strong> 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.</p>
<p><strong>INTERVENTION:</strong> 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.</p>
<p><strong>OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:</strong> 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.</p>
<p><strong>RESULTS AND LIMITATIONS:</strong> 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]).</p>
<p><strong>CONCLUSIONS:</strong> In men with recurrent bulbar urethral stricture, both urethroplasty and urethrotomy improved voiding symptoms. The benefit lasted longer for urethroplasty.</p>
<p><strong>PATIENT SUMMARY:</strong> 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.</p> |
| first_indexed | 2024-03-06T19:13:28Z |
| format | Journal article |
| id | oxford-uuid:178e2d9c-e337-4fdc-9968-626765ca10e2 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-06T19:13:28Z |
| publishDate | 2020 |
| publisher | Elsevier |
| record_format | dspace |
| spelling | oxford-uuid:178e2d9c-e337-4fdc-9968-626765ca10e22022-03-26T10:38:06ZSurgical treatment for recurrent bulbar urethral stricture: a randomised open-label superiority trial of open urethroplasty versus endoscopic urethrotomy (the OPEN Trial)Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:178e2d9c-e337-4fdc-9968-626765ca10e2EnglishSymplectic ElementsElsevier2020Goulao, BCarnell, SShen, JMacLennan, GNorrie, JCook, JMcColl, EBreckons, MVale, LWhybrow, PRapley, TForbes, RCurrer, SForrest, MWilkinson, JAndrich, DBarclay, SMundy, AN'Dow, JPayne, SWatkin, NPickard, R<p><strong>BACKGROUND:</strong> 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.</p> <p><strong>OBJECTIVE:</strong> To compare the effectiveness and cost-effectiveness of urethrotomy with open urethroplasty in adult men with recurrent bulbar urethral stricture.</p> <p><strong>DESIGN, SETTING, AND PARTICIPANTS:</strong> 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.</p> <p><strong>INTERVENTION:</strong> 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.</p> <p><strong>OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:</strong> 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.</p> <p><strong>RESULTS AND LIMITATIONS:</strong> 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]).</p> <p><strong>CONCLUSIONS:</strong> In men with recurrent bulbar urethral stricture, both urethroplasty and urethrotomy improved voiding symptoms. The benefit lasted longer for urethroplasty.</p> <p><strong>PATIENT SUMMARY:</strong> 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.</p> |
| spellingShingle | 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 Surgical treatment for recurrent bulbar urethral stricture: a randomised open-label superiority trial of open urethroplasty versus endoscopic urethrotomy (the OPEN Trial) |
| title | Surgical treatment for recurrent bulbar urethral stricture: a randomised open-label superiority trial of open urethroplasty versus endoscopic urethrotomy (the OPEN Trial) |
| title_full | Surgical treatment for recurrent bulbar urethral stricture: a randomised open-label superiority trial of open urethroplasty versus endoscopic urethrotomy (the OPEN Trial) |
| title_fullStr | Surgical treatment for recurrent bulbar urethral stricture: a randomised open-label superiority trial of open urethroplasty versus endoscopic urethrotomy (the OPEN Trial) |
| title_full_unstemmed | Surgical treatment for recurrent bulbar urethral stricture: a randomised open-label superiority trial of open urethroplasty versus endoscopic urethrotomy (the OPEN Trial) |
| title_short | Surgical treatment for recurrent bulbar urethral stricture: a randomised open-label superiority trial of open urethroplasty versus endoscopic urethrotomy (the OPEN Trial) |
| title_sort | surgical treatment for recurrent bulbar urethral stricture a randomised open label superiority trial of open urethroplasty versus endoscopic urethrotomy the open trial |
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