Laborie | APEX | NCT06560476

About

Benign prostatic hyperplasia (BPH) is a common, non-cancerous enlargement of the prostate that restricts urine flow. It affects roughly half of men in their 50s and over 80% of men in their 80s, making it one of the most prevalent conditions in aging men. Symptoms include a weak or slow urine stream, frequent nighttime urination, and difficulty starting or fully emptying the bladder. These symptoms can significantly impact daily life and well-being. The Optilume™ BPH Catheter System is an FDA-cleared, minimally invasive office-based treatment option for this condition.

Purpose

This prospective real-world registry captures safety and effectiveness data on the Optilume™ BPH Catheter System—a drug-coated balloon device cleared by the FDA for treating BPH. During a brief outpatient procedure, the balloon dilates the prostatic urethra and delivers paclitaxel to help maintain the opening over time. Enrolling 500 patients across multiple US sites, this registry documents outcomes in everyday clinical practice, beyond the controlled conditions of randomized trials.

Eligibility

• Adult men treated with the Optilume™ BPH Catheter System per FDA-cleared indications
• No confirmed or suspected prostate or bladder cancer
• No active urinary tract infection at time of treatment
• No artificial urinary sphincter or indwelling urethral stent in place
• Able to abstain from sexual intercourse or use a condom for 30 days post-procedure

Benefits

If you qualify for the study, all study-related medical care and treatment will be provided to you at no cost. You may receive a stipend for your participation in the study.

Send us a message if you are interested in participating in a study.