Introduction: The Optilume Drug Coated Balloon has been studied in three clinical investigations (ROBUST I, II and III). ROBUST I was the first in man trial conducted as a single arm, prospective multicenter study in Latin America (4 sites, 53 subjects) followed by ROBUST II assessing early feasibility (5 sites, 15 subjects), and ROBUST III, the randomized pivotal trial (79 Optilume). Optilume data combined from all three studies are presented here. Methods: A total of 148 subjects were treated with Optilume in ROBUST I, II and III in Latin America, Canada, and the United States. Men with strictures = 3cm and 1-4 prior endoscopic interventions were treated with Optilume. Follow-up was completed at 3 months, 6 months and annually thereafter. All studies were designed to follow subjects through 5 years with Robust I at 4-year follow-up, Robust II at 3-year follow-up and Robust III at 2-year follow-up, currently. Outcomes included International Prostate Symptom Score (IPSS), quality of life, freedom from reintervention, erectile function, flow rate, and post-void residual volume. Subjects receiving secondary treatment were considered failures. The safety endpoint assessed serious urinary events. Results: At the time of this abstract submission, IPSS improved in all patients treated with Optilume from 22.5 at baseline to 7.8 at 4 years. Peak urinary flow rate (Qmax) had a sharp improvement and was sustained through follow-up in all trials (7.1 to 14). Freedom from repeat intervention is approximately 73% at 4 year follow-up (Figure 1). Results will be updated at the time of the presentation. Conclusions: Subjects with recurrent bulbar strictures treated with Optilume® paclitaxel-coated balloon exhibited significant improvement in symptomatic and functional outcomes through 4 years post treatment with demonstrably improved recurrence rates. There was no impact on erectile function and there were no serious adverse events. SOURCE OF Funding: Urotronic
.jpg "Rachel A. Mann, MD, BS (she/her/hers) photo")
