Pediatric & Adult Reconstruction, Wednesday, June 30, 2021

摘要

Introduction: Mechanical dilation and direct visualization internal urethrotomy are the most widely used treatments for urethral stricture disease in Canada, but recurrence rates are high after re-treatment. This study investigates the safety and efficacy of the OptilumeTM paclitaxel-coated balloon for treatment of recurrent anterior strictures. Methods: Men with recurrent bulbar strictures ≤2 cm with 1–4 prior endoscopic treatments were treated with the Optilume drug-coated balloon. Patients have been followed at three months, six months, and annually through three years. The primary safety endpoint was serious urinary adverse events. The primary efficacy endpoint was the proportion of subjects with ≥50% improvement in International Prostate Symptom Score (IPSS) at three years. Subjects receiving secondary treatment were treated as failures for this endpoint. Secondary outcomes included quality of life, freedom from repeat intervention, erectile function, flow rate, and post-void residual (PVR) urine volume. Results: Fifty-three subjects were enrolled and treated; 43 were evaluable at the three-year followup for the primary endpoint. Forty-three percent of men had undergone 1 previous dilations, with a mean of 1.7 prior dilations. There were no serious adverse events related to treatment at three years. Success was achieved in 29/43 (67%), which is consistent with two-year results (Fig. 1). IPSS improved from a mean of 25.2 at baseline to 5.5 at three years (p0.0001). Freedom from repeat intervention of the study stricture was 33/43 (77%). Quality of life, flow rate, and PVR improved significantly from baseline. There was no impact on erectile function.Conclusions: Subjects with recurrent bulbar strictures treated with Optilume paclitaxel-coated balloon exhibited significant improvement in symptomatic and functional outcomes through three years. The rate of success is consistent with reported two-year outcomes. Long-term followup will continue through five years in the ROBUST I study and a randomized study is ongoing.