Evidence map›Paper›PMID 33228846›Full record

Trial reportHealth technology assessment (Winchester, England)2020

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

Robert Pickard, Beatriz Goulao, Sonya Carnell, Jing Shen, Graeme MacLennan, John Norrie, Matt Breckons, Luke Vale, Paul Whybrow, Tim Rapley and 12 more

Open access · diamondAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Health technology assessment (Winchester, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
3.5field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 20 citations in OpenAlex.

  1. Trial
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  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors at 8 institutions in 1 country.

Robert PickardInstitute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.ORCID 0000-0001-6151-9031
Beatriz GoulaoHealth Services Research Unit, University of Aberdeen, Aberdeen, UK.ORCID 0000-0003-1490-7183
Sonya CarnellNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.ORCID 0000-0002-7648-4297
Jing ShenInstitute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.ORCID 0000-0001-8450-5003
Graeme MacLennanCentre for Healthcare and Randomised Trials, University of Aberdeen, Aberdeen, UK.ORCID 0000-0002-1039-5646
John NorrieUsher Institute, University of Edinburgh, Edinburgh, UK.ORCID 0000-0001-9823-9252
Matt BreckonsInstitute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.ORCID 0000-0003-3057-6767
Luke ValeInstitute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.ORCID 0000-0001-8574-8429
Paul WhybrowHull York Medical School, Hull, UK.ORCID 0000-0002-6899-9581
Tim RapleySocial Work, Education & Community Wellbeing, University of Northumbria, Newcastle upon Tyne, UK.ORCID 0000-0003-4836-4279
Rebecca ForbesNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.ORCID 0000-0002-2391-1371
Stephanie CurrerNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.ORCID 0000-0002-7074-9370
Mark ForrestCentre for Healthcare and Randomised Trials, University of Aberdeen, Aberdeen, UK.ORCID 0000-0003-3152-2410
Jennifer WilkinsonNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.ORCID 0000-0002-2032-9271
Elaine McCollInstitute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.ORCID 0000-0001-8300-3204
Daniela AndrichUniversity College London Hospitals NHS Foundation Trust, London, UK.ORCID 0000-0002-9121-8691
Stewart BarclayPatient representative.ORCID 0000-0003-4447-3355
Jonathan CookOxford Clinical Trials Research Unit, Oxford University, Oxford, UK.ORCID 0000-0002-4156-6989
Anthony MundyUniversity College London Hospitals NHS Foundation Trust, London, UK.ORCID 0000-0002-6614-5179
James N'DowAcademic Urology Unit, University of Aberdeen, Aberdeen, UK.ORCID 0000-0001-5340-0081
Stephen PayneCentral Manchester Hospitals NHS Foundation Trust, Manchester, UK.ORCID 0000-0001-5359-1877
Nick WatkinSt George's University Hospitals NHS Foundation Trust, London, UK.ORCID 0000-0002-9747-8881
Newcastle University · GBUniversity of Aberdeen · GBUniversity College London Hospitals NHS Foundation Trust · GBHull York Medical School · GBNorthumbria University · GBSt George’s University Hospitals NHS Foundation Trust · GBUniversity of Edinburgh · GBUniversity of Oxford · GB

Funding

Department of Health 10/57/23Medical Research Council MR/K02325X/1
6 · The paper itself

Abstract

backgroundMen 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.

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

designParallel-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.

settingUK NHS with recruitment from 38 hospital sites.

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

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

main outcome measuresThe 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.

resultsThe 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; 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.

conclusionsThe 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 registrationCurrent Controlled Trials ISRCTN98009168.

fundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full in

Indexed as

AdultAgedCost-Benefit AnalysisEndoscopyHumansInterviews as TopicMaleMiddle AgedModels, EconomicQuality-Adjusted Life YearsQuality of LifeState MedicineTechnology Assessment, BiomedicalUnited KingdomUrethral StrictureUrologic Surgical Procedures, MaleBULBAR URETHRAL STRICTURECOST-EFFECTIVENESS ANALYSISHEALTH STATUSLOWER URINARY TRACT SYMPTOMSMALEOUTCOME ASSESSMENT QUALITATIVE PROCESS EVALUATIONRANDOMISED CONTROLLED TRIALRECURRENCEURETHROPLASTYURETHROTOMY

Identifiers

PMID33228846
PMCPMC7750862
OpenAlexW3107520000

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.