Shen, Jing
Vale, Luke
Goulao, Beatriz
Whybrow, Paul
Payne, Stephen
Watkin, Nick
Dorkin, Trevor
Watkin, Nick
Mundy, Anthony
Anderson, Paul
Venn, Suzie
Eardley, Ian
Dickerson, David
Thiruchelvam, Nikesh
Inman, Richard
Chapple, Chris
Baird, Andrew
Sinclair, Andrew
Krishnanm, Rajeshwar
Rees, Rowland
N’dow, James
Montgomery, Bruce
Swinn, Michael
Henderson, Alastair
Donohue, John
Venn, Suzie
Mason, Robert
Madaan, Sanjeev
Hilmy, Mustafa
Kirchin, Vivienne
Davenport, Kim
McGrath, John
Porter, Tim
MacDonagh, Ruaraidh
Birring, Amerdip
Ravi, Ramachandran
Husain, Jawad
Shabbir, Maj
Baldo, Omer
Chitale, Sadhanshu
Garthwaite, Mary
Srirangam, Shalom
Chowoo, Liaqat
Rashid, Tina
Skyrme, Rob
Featherstone, Jon
Alhasso, Ammar
Tatarov, Oleg
,
Clinical trials referenced in this document:
Documents that mention this clinical trial
Endoscopic urethrotomy versus open urethroplasty for men with bulbar urethral stricture: the OPEN randomised trial cost-effectiveness analysis
https://doi.org/10.1186/s12894-021-00836-1
Open urethroplasty versus endoscopic urethrotomy for recurrent urethral stricture in men: the OPEN RCT (Results)
https://doi.org/10.3310/hta24610
Article History
Received: 11 December 2020
Accepted: 12 April 2021
First Online: 3 May 2021
Declarations
:
: The study was conducted in line with all relevant guidelines and regulations for the conduct of a randomised controlled trial. The underlying study design was approved by the funder (UK NIHR HTA programme) in the original funding application. The detailed study protocol was approved by the Trial Steering Committee (comprising an independent clinician who acted as chairperson, two further independent clinicians, an independent statistician, a lay representative and the Chief Investigator). In addition the economic evaluation reported in this paper complied with the CHEERS checklist for the reporting of an economic evaluation.
: The Newcastle upon Tyne Hospitals NHS Foundation Trust Research and Development Directorate sponsored the trial (Reference 6332). Favourable ethical opinion for the trial was obtained on 16th October 2012 from the NHS Research Ethics Service Committee North East—Newcastle and North Tyneside (Reference: 12/NE/0343) and subsequent Research and Development and Caldicott approvals were granted by each participating site.
: Study participants were consented at individual participating site following the procedure set out in the trail protocol. Trial information was provided and potential participants were given at least 48 h to consider participation in the study. Following review, at a mutually convenient time, those men who wanted to take part, who fulfilled the entry criteria and who understood the rationale and conduct of the trial, provided informed consent witnessed by research staff at site with delegated approval to do so. The right to refuse to participate without giving reasons was respected.
: Not applicable.
: All authors declare no competing interests.