Newcastle Clinical Trials Unit

Open

Open

Clarifying the management of men with recurrent urethral stricture:a pragmatic, randomised, multicentre superiority trial of open urethroplasty versus endoscopic urethrotomy

  • Study stage: Closed
  • Sponsor: The Newcastle Upon Tyne Hospitals NHS Foundation Trust
  • Funder: NIHR HTA
  • Therapeutic area: Renal and Urogenital
  • Type of study: Surgical

Aim:

1. Determine the intervention for recurrent bulbar urethral stricture that offers the most effective symptom control over 24 months.

2. Determine the relative cost-effectiveness of each intervention over 24 months.

Primary outcome:

Area under curve (AUC) for serial repeated measurement of ICIQ-Male Short Form (ICIQ-Male SF) questionnaire over 24 months following randomisation.

  • Population: Adults (males)
  • Design: Pragmatic RCT, Qualitative and Health Economics.
  • Setting: Secondary Care
  • Planned Sample Size: 210

Website: www.opentrial.co.uk