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 - 02/05/26

Doi : 10.1016/j.urology.2026.04.009

Mário Henrique Bitar Siqueira ^a,^{^{1
ORCID: 0009-0006-2867-9723}}, Omar Buksh ^a, Abbas Hammoud ^b, Naeem Bhojani ^c, Malek Meskawi ^c, Bilal Chughtai ^d, Kevin C. Zorn ^e, Katherine Lajkosz ^f, Ahmed Zakaria ^g, Hazem Elmansy ^h, Premal Patel ⁱ, Edward Matsumoto ^j, Dean Elterman ^a,^⁎

^a Division of Urology, Department of Surgery, University of Toronto, Toronto, Ontario, Canada

^b American University of Beirut, Beirut, Lebanon

^c Division of Urology, Centre Hospitalier de l′Université de Montréal (CHUM), Montréal, Quebec, Canada

^d Plainview Hospital, Smith Institute of Urology, Northwell Health, Syosset, NY

^e BPH Canada, Prostate Surgical Institute, Montreal, Quebec, Canada

^f Department of Biostatistics, University Health Network, Toronto, Ontario, Canada

^g Northern Ontario School of Medicine/Thunder Bay Regional Health Research Institute, Thunder Bay, Ontario, Canada

^h Houston Methodist Hospital, Houston, TX

ⁱ Men’s Health Clinic, Winnipeg, Manitoba, Canada

^j St. Joseph Hospital, Hamilton, Hamilton, Ontario, Canada

^⁎ Address correspondence to: Dean Elterman, M.D., M.Sc., F.R.C.S.C., Division of Urology, Department of Surgery, University of Toronto, 399 Bathurst Street, MP-8-317, Toronto, ON M5T 2S8, Canada. Division of Urology, Department of Surgery, University of Toronto 399 Bathurst Street, MP-8-317 Toronto ON M5T 2S8 Canada

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ABSTRACT

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.