11-Year Outcome Analysis of Endourethral Prosthesis for the Treatment of Recurrent Bulbar Urethral Stricture

Abstract

In a North American multicenter trial of endourethral prosthesis for the treatment of recurrent bulbar urethral stricture we reported 2-year followup results for patients treated with the UroLume endoprosthesis (American Medical Systems, Inc., Minnetonka, Minnesota) between 1989 and 1996. From that same study we report long-term effectiveness and safety results on 24 of 179 patients, all of whom have completed 11 years of followup. The North American Study Group enrolled 179 patients with recurrent bulbar urethral stricture between March 1989 and April 1996. Eleven-year post-implantation followup was obtained for 24 of these original patients in a post-approval study. Evaluation included uroflowmetry before versus after insertion, urinary symptom score, local tissue changes and percentage of stent covered by epithelium. At 11 years mean flow rates before and after stenting were 9.5 and 20.8 ml per second, respectively, and mean urinary symptom scores were 11.3 before and 3.04 after stent. No demonstrable tissue changes were visualized at the site of the stent in 31.8%, while 40.9% had mild, 22.7% had moderate and 4.6% had marked changes. There were 8 patients who underwent 9 re-treatment procedures within the stented area during followup. When used appropriately the UroLume Endoprosthesis is an effective treatment for recurrent bulbar urethral stricture. It has low morbidity, re-treatment and explantation rates, and local tissue change was mild or nonexistent in the majority of patients.