UROLUME ENDOURETHRAL PROSTHESIS FOR THE TREATMENT OF URETHRAL STRICTURE DISEASE - LONG-TERM RESULTS OF THE NORTH-AMERICAN MULTICENTER UROLUME TRIAL

Objectives. To evaluate the long-term results of the UroLume endourethral prosthesis for the treatment of recurrent bulbar urethral strictures. Methods. In a multicenter, prospective study 175 patients with recurrent bulbar urethral strictures were enrolled in a Food and Drug Administration (FDA) trial of the UroLume endourethral prosthesis. One hundred thirty-nine patients were available for follow-up at 1 year, and 81 patients were available for follow-up at 2 years. Results. Clinically and statistically significant results were seen at 1 year and sustained at 2 years. Re-treatment rate was down from 75.2% preinsertion to 14.3% 1 year postinsertion of the prosthesis. Explantation was required in only 3% of patients. Conclusions. Based on these and European data, the UroLume endourethral prosthesis offers a significant advantage over the currently available treatments for recurrent bulbar urethral strictures.