Hypothesis / aims of study
The Optilume® drug-coated balloon (DCB) represents an innovative therapy for lower urinary tract symptoms (LUTS), integrating mechanical dilation for prompt symptom improvement with targeted paclitaxel delivery. This study examines the safety profile and functional outcomes of the Optilume BPH catheter system in one year.
Study design, materials and methods
This prospective, single-arm, multi-center, open-label study will be conducted at Canadian centers with 24 patients to evaluate the safety of the endoscopic Optilume BPH drug-coated balloon procedure for LUTS due to BPE from July 2022 to January 2025. The study will assess the complication rate at 90 days and evaluate functional outcomes at baseline, 3, 6, and 12 months.
Results
Out of 24 patients, 17 (70.8%) experienced a total of 42 adverse events (AEs), the majority of which were mild (Grade I: 70.8%). The most reported side effects were hematuria (41.6%), dysuria (16.6%), urinary tract infection (UTI) (8.4%), and urinary urgency (8.4%). Significant symptomatic improvement was observed over time. IPSS scores decreased from 22.5 ± 5.1 at baseline to 11 ± 6.6 at 12 months, while QoL scores improved from 4.6 ± 1.3 to 1.9 ± 1.4 over the same period. Qmax increased from 9.4 ± 3.6 mL/s to 15.7 ± 4.9 mL/s at 3 months, remaining stable at 15.3 ± 7.7 mL/s at 12 months. Post-void residual (PVR) volume decreased from 96.3 ± 83.9 mL to 68.1 ± 43.9 mL at 12 months, reflecting sustained improvements in urinary function. No significant differences were observed in sexual function scores, including IIEF, MSHQ function, and bother scores, indicating that the procedure did not negatively impact sexual health
Interpretation of results
The Optilume BPH drug-coated balloon procedure demonstrated significant symptomatic and functional improvements while maintaining a favorable safety profile over 12 months. Most adverse events were mild and self-limiting, with no serious complications or need for surgical intervention. Improvements in IPSS, QoL, Qmax, and PVR were sustained over time, and sexual function remained stable.