Open urethroplasty versus endoscopic urethrotomy for recurrent urethral stricture in men: the OPEN RCT

Area of Science:

• Urology
• Health Technology Assessment
• Clinical Effectiveness Research

Background:

• Recurrent bulbar urethral stricture presents a treatment dilemma for men, with limited evidence comparing endoscopic urethrotomy and open urethroplasty.
• The clinical effectiveness and cost-effectiveness of these surgical options for managing recurrent strictures remain unclear.

Purpose of the Study:

• To assess the benefits, harms, and cost-effectiveness of open urethroplasty versus endoscopic urethrotomy for treating recurrent urethral stricture in men.
• To compare the rates of reintervention and patient-reported symptom control between the two surgical approaches.

Main Methods:

• A parallel-group, open-label, patient-randomised trial involving 222 men with recurrent bulbar urethral stricture across 38 UK NHS sites.
• Participants were randomised 1:1 to either open urethroplasty or endoscopic urethrotomy, with 6-monthly follow-ups over 24 months.
• Primary outcomes included urinary symptom control and cost-effectiveness (cost per quality-adjusted life-year), with reintervention rates as a key secondary outcome.

Main Results:

• Both procedures resulted in similar improvements in voiding symptoms over 24 months (mean difference in symptom score AUC: -0.36).
• Open urethroplasty showed a significantly lower rate of reintervention (hazard ratio: 0.52; p=0.02) but incurred higher costs (£2148 more per patient).
• Endoscopic urethrotomy was found to be more cost-effective, yielding similar quality-adjusted life-years (QALYs) at a lower cost.

Conclusions:

• Both open urethroplasty and endoscopic urethrotomy effectively control urinary symptoms in men with recurrent bulbar urethral stricture.
• While urethroplasty reduces the need for reintervention, its higher cost makes urethrotomy the more cost-effective option based on current evidence.
• Further research is recommended to incorporate short-term disutility data and establish national outcome audits.