To provides an overview of the functional and safety outcomes associated with the Optilume BPH catheter system.
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.
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 ± 3.7mL/s to 15.9 ± 5.7mL/s at 3 months, remaining stable at 14.7 ± 6.9mL/s at 12 months. No significant differences were observed in sexual function scores.
The Optilume BPH drug-coated balloon procedure demonstrated significant symptomatic and functional improvements over 12 months.
Urology. 2026 Apr 13 [Epub ahead of print]
Mário Henrique Bitar Siqueira, Omar Buksh, Abbas Hammoud, Naeem Bhojani, Malek Meskawi, Bilal Chughtai, Kevin C Zorn, Katherine Lajkosz, Ahmed Zakaria, Hazem Elmansy, Premal Patel, Edward Matsumoto, Dean Elterman
Division of Urology, Department of Surgery, University of Toronto, Toronto, Canada. Electronic address: ., Division of Urology, Department of Surgery, University of Toronto, Toronto, Canada. Electronic address: ., American University of Beirut, Beirut, Lebanon. Electronic address: ., Division of Urology, Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Canada. Electronic address: ., Division of Urology, Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Canada. Electronic address: ., Plainview Hospital, Smith Institute of Urology, Northwell Health, Syosset, United States. Electronic address: ., BPH Canada, Prostate Surgical Institute, Montreal, Canada. Electronic address: ., Department of Biostatistics, University Health Network, Toronto, Ontario, Canada. Electronic address: ., Northern Ontario School of Medicine/ Thunder Bay Regional Health Research Institute, Thunder Bay, Ontario. Electronic address: ., Houston Methodist Hospital, Houston, Texas, United States. Electronic address: ., Men's Health Clinic, Winnipeg, Manitoba. Electronic address: ., St. Joseph Hospital, Hamilton, Hamilton, Ontario. Electronic address: ., Division of Urology, Department of Surgery, University of Toronto, Toronto, Canada. Electronic address: .