Clarifying the management of men with recurrent urethral stricture

A pragmatic, randomised, multicentre superiority trial of open urethroplasty versus endoscopic urethrotomy


Study overview

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. 

For men with a bulbar urethral stricture disease who recur after initial urethrotomy, the best way to tackle the recurrent stricture is uncertain.  Repeat urethrotomy and urethroplasty are both reasonable options, and the choice between the two is the focus of this study.  Repeat urethrotomy is more commonly performed for recurrent bulbar stricture because it is minimally invasive; does not require specialist surgical expertise, and has a short period of catheterisation and recovery.  In open urethroplasty, the urethra is approached through a skin incision in the perineum behind the scrotum and the narrow section is cut out (excised) or reconstructed.  For strictures that are short and supple, simple excision and re-joining of the cut ends is performed (anastomotic urethroplasty).  Most strictures however require a patch of graft material (patch urethroplasty) to rebuild the diseased area and permanently widen the lumen.

In the end, individual men have to make a trade off the between the invasiveness and effectiveness of each operation.  In the NHS at the present time the decision-making process may be influenced by availability of local expertise and clinician guidance.  In the OPEN trial, men with recurrent bulbar urethral strictures will be randomized to open urethroplasty or endoscopic urethrotomy.  The aim is to determine which operation is most clinically-effective and which operation is most cost-effective.




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