Optilume BPH Catheter System Delivers Durable Two-Year Relief for BPH Symptoms

The PINNACLE study demonstrates that the Optilume BPH Catheter System provides sustained symptom relief and improved urinary function in men with benign prostatic hyperplasia (BPH), with continued safety and tolerability over two years.

This randomized controlled trial enrolled 148 men with symptomatic BPH, randomized 2:1 to the Optilume BPH system or a sham procedure.

Long-term outcomes included:

•    International Prostate Symptom Score (IPSS)
•    Peak urinary flow rate (Qmax)
•    Post-void residual urine (PVR)
•    Quality of life (QoL) measures
•    Sexual function

Follow-up beyond one year was conducted only for the Optilume group.

At two years, 67.5% of participants treated with the Optilume system achieved symptomatic response, defined as a ≥30% improvement in IPSS without additional medical or surgical intervention. 

IPSS scores improved significantly, from 23.4 to 11.0, and Qmax increased by 116.8%, from 8.9 mL/s to 19.0 mL/s. PVR reduced modestly, while QoL improved substantially, with IPSS QoL scores decreasing from 4.6 to 2.2. Importantly, improvements were consistent across all prostate volumes, and no negative impact on sexual function was observed.

Common adverse events included hematuria and urinary tract infections, but no serious device- or treatment-related complications were reported beyond 12 months.

The Optilume BPH system offers a durable and minimally invasive alternative to traditional therapies, combining lasting symptom relief with a favorable safety profile, making it a promising option for BPH management.