Urethral stricture is a narrowing of the urethra caused by scarring after injury or infection. It is the commonest cause of difficulty passing urine in younger and middle aged men. The prevalence is approximately 200 per 100,000 men in their 20s rising to 900 per 100,000 men in their 70s. Urethral strictures affect about 62,000 men in the UK at any one time. In the NHS in England this corresponds to 17,000 hospital admissions annually, 16,000 bed-days and 12,000 operations at a cost in excess of £10M.
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.
The OPEN trial, funded by the NIHR HTA Programme, was a multicentre randomised trial comparing open urethroplasty with endoscopic urethrotomy in men with recurrent bulbar urethral strictures. The trial aimed to recruit 210 men. The primary outcome was the area under curve (AUC) for serial repeated measurement of International Consultant on Incontinence Modular Questionnaire Male Form (ICIQ-Male SF) questionnaire over 24 months following randomisation.
The OPEN trial was led by Professor Robert Pickard based at University of Newcastle.