LAUSR

treatment of urethral stricture. METHODS: Men with bulbar urethral strictures <[ 2cm with 13 prior endoscopic treatments were enrolled at 4 study sites in the Dominican Republic and Panama following Ethics Committee approvals. The DCB was inflated under cystoscopic visualization and placement confirmed via fluoroscopy. International Prostate Symptom Score (IPSS) was documented at 3, 6, 12 and 24 months. Cystoscopy was documented at 6 and 12 months. Primary efficacy endpoint was improvement in IPSS and primary safety endpoint was serious complications through 3 months. We also report updated results of our composite definition of success: (1) no retreatment; (2) no recurrence on cystoscopy; and (3) IPSS<[11 at last follow-up. For the 2-year outcomes data, men were considered successful if they had a normal cystoscopy at 12 months and IPSS remained <[11 at 2 years. If IPSS was >11 at 2 years then men were considered a failure and cystoscopy was not repeated inside the study protocol. RESULTS: Results: Fifty-three subjects were enrolled, and all successfully treated. Average subject age was 51 years (range 2281). Average number of prior treatments was 1.8 per subject (range 1-4). There were no serious or unexpected device related adverse events. Mean IPSS decreased from 25.2 4.5 (baseline) to 7.3 8.10 (p < 0.001) in 41 men with 24-month data. Two-year success based on the composite definition was 30/45 (67%), compared to 32/ 46 (70%) at 1 year. Failures in year 2 included 2 men with a new increase in IPSS > 11; censors in year 2 included 1 man lost to follow-up; no man was retreated in year 2. CONCLUSIONS: Conclusions: Two-year data indicate that in men with short bulbar urethral stricture refractory to standard endoscopic management, the paclitaxel DCB is safe and produces a durable improvement in IPSS.