Presented by: Dean Elterman MD, MSc, FRCSC
University of Toronto

Introduction

The Optilume Drug Coated Balloon has been studied in three clinical investigations (ROBUST I, II and III). ROBUST I, the first in-man trial conducted as a single arm, prospective multicenter study (4 sites, 53 subjects) followed by ROBUST II, early feasibility (5 sites, 15 subjects), and ROBUST III, the randomized pivotal trial (79 Optilume subjects). Optilume data combined from all three studies is presented here.

Materials

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 anterior urethral 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 currently at 4-year follow-up, ROBUST II at 3-year follow-up and ROBUST III at 2-year follow-up, respectively.

Outcomes included anatomic success at 6 months, International Prostate Symptom Score (IPSS), quality of life, freedom from repeat intervention, erectile function, flow rate (Qmax), and post-void residual volume. Subjects receiving secondary treatment were considered failures. The safety endpoint assessed serious urinary events. Patients who failed standard of care therapy in the control arm of ROBUST III were allowed to cross over at 6 months and were followed.

Results

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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 had a sharp, sustained improvement for patients treated with Optilume through follow-up (7.1 to 14). Freedom from repeat intervention is approximately 73% at 4-year follow-up. Patients who crossed over in the ROBUST III study experienced significant improvements in IPSS and Qmax. Results will be updated at the time of the presentation.

Conclusion

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.

Funding

Urotronic

Co-Authors

Sean Elliott, MD, MS
University of Minnesota

Jessica DeLong, MD
Eastern Virginia Medical School

Ramon Virasoro, MD
Eastern Virginia Medical School