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; Matt Breckons; Luke Vale; Paul Whybrow; Tim Rapley; Rebecca Forbes; Stephanie Currer; Mark Forrest; Jennifer Wilkinson; Daniela Andrich; Stewart Barclay; Anthony Mundy; James N'Dow; Stephen Payne; Nick Watkin; Robert Pickard

doi:10.1016/j.eururo.2020.06.003

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, Matt Breckons, Luke Vale, 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

Research output: Contribution to journal › Article › peer-review

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 language	English
Journal	European Urology
Early online date	4 Jul 2020
DOIs	https://doi.org/10.1016/j.eururo.2020.06.003
Publication status	E-pub ahead of print - 4 Jul 2020

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10.1016/j.eururo.2020.06.003

https://www.sciencedirect.com/science/article/pii/S0302283820304309?via%3Dihub

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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. Advance online publication. https://doi.org/10.1016/j.eururo.2020.06.003

@article{31206a860b764b9eb9b75d53dacd6421,

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

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.",

author = "Beatriz Goulao and Sonya Carnell and Jing Shen and Graeme MacLennan and John Norrie and Jonathan Cook and Elaine McColl and Matt Breckons and Luke Vale and Paul Whybrow and Tim Rapley and Rebecca Forbes and Stephanie Currer and Mark Forrest and Jennifer Wilkinson and Daniela Andrich and Stewart Barclay and Anthony Mundy and James N'Dow and Stephen Payne and Nick Watkin and Robert Pickard",

note = "Copyright {\textcopyright} 2020. Published by Elsevier B.V.",

year = "2020",

month = jul,

day = "4",

doi = "10.1016/j.eururo.2020.06.003",

language = "English",

journal = "European Urology",

issn = "0302-2838",

publisher = "Elsevier",

}

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 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. https://doi.org/10.1016/j.eururo.2020.06.003

TY - JOUR

T1 - Surgical Treatment for Recurrent Bulbar Urethral Stricture

T2 - A Randomised Open-label Superiority Trial of Open Urethroplasty Versus Endoscopic Urethrotomy (the OPEN Trial)

AU - Goulao, Beatriz

AU - Carnell, Sonya

AU - Shen, Jing

AU - MacLennan, Graeme

AU - Norrie, John

AU - Cook, Jonathan

AU - McColl, Elaine

AU - Breckons, Matt

AU - Vale, Luke

AU - Whybrow, Paul

AU - Rapley, Tim

AU - Forbes, Rebecca

AU - Currer, Stephanie

AU - Forrest, Mark

AU - Wilkinson, Jennifer

AU - Andrich, Daniela

AU - Barclay, Stewart

AU - Mundy, Anthony

AU - N'Dow, James

AU - Payne, Stephen

AU - Watkin, Nick

AU - Pickard, Robert

PY - 2020/7/4

Y1 - 2020/7/4

N2 - 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.

AB - 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.

U2 - 10.1016/j.eururo.2020.06.003

DO - 10.1016/j.eururo.2020.06.003

M3 - Article

C2 - 32636099

SN - 0302-2838

JO - European Urology

JF - European Urology

ER -

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

Abstract

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