Open urethroplasty versus endoscopic urethrotomy for recurrent urethral stricture in men: the OPEN RCT

Pickard, Robert, Goulao, Beatriz, Carnell, Sonya, Shen, Jing, MacLennan, Graeme, Norrie, John, Breckons, Matt, Vale, Luke, Whybrow, Paul, Rapley, Tim, Forbes, Rebecca, Currer, Stephanie, Forrest, Mark, Wilkinson, Jennifer, McColl, Elaine, Andrich, Daniela, Barclay, Stewart, Cook, Jonathan, Mundy, Anthony, N’Dow, James, Payne, Stephen and Watkin, Nick (2020) Open urethroplasty versus endoscopic urethrotomy for recurrent urethral stricture in men: the OPEN RCT. Health Technology Assessment, 24 (61). pp. 1-110. ISSN 1366-5278

[img]
Preview
Text
3035006.pdf - Published Version

Download (7MB) | Preview
Official URL: http://doi.org/10.3310/hta24610

Abstract

Background
Men who suffer recurrence of bulbar urethral stricture have to decide between endoscopic urethrotomy and open urethroplasty to manage their urinary symptoms. Evidence of relative clinical effectiveness and cost-effectiveness is lacking.

Objectives
To assess benefit, harms and cost-effectiveness of open urethroplasty compared with endoscopic urethrotomy as treatment for recurrent urethral stricture in men.

Design
Parallel-group, open-label, patient-randomised trial of allocated intervention with 6-monthly follow-ups over 24 months. Target sample size was 210 participants providing outcome data. Participants, clinicians and local research staff could not be blinded to allocation. Central trial staff were blinded when needed.

Setting
UK NHS with recruitment from 38 hospital sites.

Participants
A total of 222 men requiring operative treatment for recurrence of bulbar urethral stricture who had received at least one previous intervention for stricture.

Interventions
A centralised randomisation system using random blocks allocated participants 1 : 1 to open urethroplasty (experimental group) or endoscopic urethrotomy (control group).

Main outcome measures
The primary clinical outcome was control of urinary symptoms. Cost-effectiveness was assessed by cost per quality-adjusted life-year (QALY) gained over 24 months. The main secondary outcome was the need for reintervention for stricture recurrence.

Results
The mean difference in the area under the curve of repeated measurement of voiding symptoms scored from 0 (no symptoms) to 24 (severe symptoms) between the two groups was –0.36 [95% confidence interval (CI) –1.78 to 1.02; p = 0.6]. Mean voiding symptom scores improved between baseline and 24 months after randomisation from 13.4 [standard deviation (SD) 4.5] to 6 (SD 5.5) for urethroplasty group and from 13.2 (SD 4.7) to 6.4 (SD 5.3) for urethrotomy. Reintervention was less frequent and occurred earlier in the urethroplasty group (hazard ratio 0.52, 95% CI 0.31 to 0.89; p = 0.02). There were two postoperative complications requiring reinterventions in the group that received urethroplasty and five, including one death from pulmonary embolism, in the group that received urethrotomy. Over 24 months, urethroplasty cost on average more than urethrotomy (cost difference £2148, 95% CI £689 to £3606) and resulted in a similar number of QALYs (QALY difference –0.01, 95% CI –0.17 to 0.14). Therefore, based on current evidence, urethrotomy is considered to be cost-effective.

Limitations
We were able to include only 69 (63%) of the 109 men allocated to urethroplasty and 90 (80%) of the 113 men allocated to urethrotomy in the primary complete-case intention-to-treat analysis.

Conclusions
The similar magnitude of symptom improvement seen for the two procedures over 24 months of follow-up shows that both provide effective symptom control. The lower likelihood of further intervention favours urethroplasty, but this had a higher cost over the 24 months of follow-up and was unlikely to be considered cost-effective.

Future work
Formulate methods to incorporate short-term disutility data into cost-effectiveness analysis. Survey pathways of care for men with urethral stricture, including the use of enhanced recovery after urethroplasty. Establish a pragmatic follow-up schedule to allow national audit of outcomes following urethral surgery with linkage to NHS Hospital Episode Statistics.

Trial registration
Current Controlled Trials ISRCTN98009168.

Funding
This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 61. See the NIHR Journals Library website for further project information.

Item Type: Article
Additional Information: © Queen’s Printer and Controller of HMSO 2020. This work was produced by Pickard et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. Permission to reproduce material from the published report is covered by the UK government’s non-commercial licence for public sector information: (http://www.nationalarchives.gov.uk/doc/non-commercial-government-licence/version/2/).
Uncontrolled Keywords: bulbar urethral stricture, cost-effectiveness analysis, health status, lower urinary tract symptoms, male, outcome assessment qualitative process evaluation, randomised controlled trial, recurrence, urethroplasty, urethrotomy
Subjects: A300 Clinical Medicine
Department: Faculties > Arts, Design and Social Sciences > Social Sciences
Depositing User: Ellen Cole
Date Deposited: 15 Dec 2020 13:40
Last Modified: 16 Dec 2020 13:14
URI: http://nrl.northumbria.ac.uk/id/eprint/45008

Actions (login required)

View Item View Item

Downloads

Downloads per month over past year

View more statistics