Long-term followup from the ROBUST III study: Interim two-year results
Mélanie Aubé-Peterkin1, Sean Elliott2, Ramón Virasoro3, Jessica DeLong3, Karl Coutinho4, Kaiser Robertson5, Richard D’Anna6.
1Division of Urology, Department of Surgery, McGill University Health Centre, Montreal, QC, Canada; 2Urology, University of Minnesota, Minneapolis, MN, United States; 3Urology, Eastern Virginia Medical School, Norfolk, VA, United States; 4Urology, New Jersey Urology, Millburn , NJ, United States; 5Urology, Chesapeake Urology Research Associates, Hanover, MD, United States; 6Urology, Arkansas Urology Research Center, Little Rock, AR, United States
ROBUST III Investigators.
Introduction: Recently published results from the ROBUST III study have shown that the Optilume drug-coated balloon (DCB) provides a significant improvement over standard of care endoscopic management in the treatment of anterior urethral strictures with regards to anatomic success, symptom improvement, and urinary flow at one year. Followup is ongoing for subjects in ROBUST III, with interim two-year followup presented here.
Methods: A total of 127 subjects were randomized in a 2:1 fashion at 23 sites, 79 treated with Optilume and 48 treated with standard of care. Followup past one year was limited to those treated with the Optilume DCB. Followup for two years is ongoing, with 29 of the 79 subjects completing two-year followup at the time of the writing of this abstract. Eligibility criteria included anterior strictures with ≥2 prior treatments, length ≤3 cm. Long-term endpoints included freedom from repeat treatment, International Prostate Symptom Score (IPSS), and peak urinary flow rate (Qmax).
Results: Subjects randomized to the Optilume DCB had an average of 3.2 prior treatments and an average stricture length of 1.6 cm (46% ≥2 cm), with 8/79 (10.1%) having penile strictures and 9/79 (11.4%) having prior pelvic radiation. IPSS remained significantly improved, from 22.0 at baseline to 9.7 at two years (p<0.001). Qmax also remained significantly improved, from a baseline value of 7.6 mL/sec to 13.7 mL/sec at two years (p<0.001). Freedom from repeat intervention for subjects treated with the Optilume DCB was significantly increased as compared to the repeat intervention rate for standard endoscopic management at one year. No late-onset treatment-related adverse events were observed. Two-year followup is expected to be complete by the time of abstract presentation.
Conclusions: The Optilume DCB continues to exhibit significant improvements in symptoms, flow, and reintervention rates through two years post-treatment in a difficult-to-treat patient population and represents an important new tool in the urologist's armamentarium.
