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, Matthew Breckons, Luke Vale* (Corresponding Author), 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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

16 Citations (Scopus)
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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.
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.
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]).
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 languageEnglish
Pages (from-to)572-580
Number of pages9
JournalEuropean Urology
Issue number4
Early online date4 Jul 2020
Publication statusPublished - Oct 2020

Bibliographical note

Funding/Support and role of the sponsor: This work was supported by the Newcastle University Hospitals NHS Foundation Trust for Research Governance, and funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme Clinical Evaluation and Trials Panel (trial registration ISRCTN: 98009168).
Acknowledgements: We thank the patients and health care professionals for their participation in qualitative interviews. We also thank Stewart Barclay, the patient and service user representative on the OPEN Trial Management Group. We acknowledge the Trial Steering Committee members: Roger Kockelburg (Chair), John Matthews, Alan McNeil, Howard Kynaston, Neil Campling. Data Monitoring Committee members: Gordon Murray (Chair), Richard Martin, and Thomas Pinkney. We thank Matthew Jackson (research fellow), Gladys McPherson (data manager), Lee Munro (trial manager), Rachel Stephenson (trial manager), Sue Tremble (trial manager), Robbie Brown (trial manager), Mark Deverill (health economist), Amy Collins (project secretary), Lavinia Miceli (project secretary), and Ann Payne (project secretary). Sarah Hill and David Mott contributed to the development and interviews of the TTO exercise, and Joanne O’Connor and Beena David contributed to the interviews of the TTO exercise. Assistance was provided by Peter Murphy and Wendy Robson when conducting TTO pilots in Freeman Hospital. All the volunteers who took part in the TTO pilots and participants in TTO interviews are acknowledged. The following sites and Principal Investigators are acknowledged for their support: Mr. Trevor Dorkin, Freeman Hospital, Newcastle; Professor Nick Watkin, St George's Hospital, London; Professor Anthony Mundy, University College London Hospitals; Mr. Paul Anderson, Russells Hall Hospital, Dudley; Mrs. Suzie Venn, Queen Alexandra Hospital, Portsmouth; Mr. Ian Eardley, St James University Hospital, Leeds; Mr. David Dickerson, Weston General Hospital; Mr. Nikesh Thiruchelvam,
Addenbrooke's Hospital, Cambridge; Mr. Richard Inman and Mr. Chris Chapple, Royal Hallamshire Hospital, Sheffield; Mr. Andrew Baird, University Hospital, Aintree; Mr. Andrew Sinclair, Stepping Hill Hospital; Mr. Rajeshwar Krishnanm, Kent and Canterbury Hospital; Mr. Rowland Rees, University Hospital, Southampton; Professor James N'dow, Aberdeen Royal Infirmary; Mr. Bruce Montgomery, Frimley Park Hospital, Camberley; Mr. Michael Swinn, East Surrey Hospital; Mr. Alastair Henderson, Mr. John Donohue, Maidstone Hospital; Mrs. Suzie Venn, St Richards Hospital, Chichester; Mr. Robert Mason, Torbay Hospital; Mr. Sanjeev Madaan, Darent Valley Hospital; Mr. Mustafa Hilmy, York Hospital; Miss Vivienne Kirchin, Sunderland Royal Infirmary; Kim Davenport, Cheltenham General Hospital; John McGrath, Exeter Hospital; Tim Porter, Yeovil District Hospital; RuaraidhvMacDonagh, Amerdip Birring, Musgrove Park, Taunton; Ramachandran Ravi, Basildon; Jawad Husain, Wigan; Maj Shabbir, Guy's Hospital; Omer Baldo, Airedale Hospital; Sadhanshu Chitale, Whittington Hospital; Mary Garthwaite, James Cook University Hospital; Shalom Srirangam, Royal Blackburn Hospital; Liaqat Chowoo, Bedford Hospital; Tina Rashid, Charing Cross; Rob Skyrme; Jon Featherstone, Princess of Wales Hospital, Bridgend; and Mr. Ammar Alhasso, Edinburgh; Mr Oleg Tatarov, Cardiff. We thank the following trusts for offering PIC support: Basingstoke and Northamptonshire NHS Foundation Trust; Royal Liverpool and Broadgreen University Hospitals NHS Trust; Chelsea and Westminster NHS Foundation Trust; and Wirral University Teaching Hospitals NHS Foundation Trust.


  • Surgery
  • Randmised controlled trial
  • Urethral stricture
  • Urethroplasty
  • Urethrotomy
  • Voiding sympstoms
  • Voiding symptoms
  • Randomised controlled trial


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