The SUMMIT Study: A Real-World, Clinical Study to Evaluate the Performance of the Optilume BPH Catheter System in Men With Symptomatic Benign Prostatic Hyperplasia

OBJECTIVE: To provides an overview of the functional and safety outcomes associated with the Optilume BPH catheter system. METHODS: This prospective, single-arm, multi-center, open-label study was conducted at five Canadian centers to evaluate the safety of the endoscopic Optilume BPH (DCB) procedure for LUTS due to benign prostate enlargement from July 2022 to August 2025. The study assessed functional outcomes at baseline, 3, 6, and 12 months. RESULTS: Thirty patients were included in this study, with a mean age of 63.1 ± 7.0 years. The mean prostate volume was 48.5 ± 16.6 mL. IPSS scores decreased from 23.5 ± 5.1 at baseline to 10.8 ± 7.5 at 12 months, while QoL scores improved from 4.7 ± 1.3 to 2 ± 1.6 over the same period. Qmax increased from 8.7 ± 3.7 mL/s to 15.9 ± 5.7 mL/s at 3 months, remaining stable at 14.7 ± 6.9 mL/s at 12 months. No significant differences were observed in sexual function scores. CONCLUSION: The Optilume BPH drug-coated balloon procedure demonstrated significant symptomatic and functional improvements over 12 months.