Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study
Trial Parameters
Brief Summary
The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.
Eligibility Criteria
Inclusion Criteria: 1. Male subject ≥ 50 years old 2. Diagnosed with lower urinary tract symptoms (LUTS) secondary to obstructive benign prostatic hyperplasia (BPH) 3. Able to be treated with the Optilume BPH Catheter System in accordance with the Instructions for Use 4. Prostate volume \< 80 g with a prostatic urethral length between 32-55 mm as determined by trans-rectal ultrasound (TRUS) 5. International Prostate Symptom Score (IPSS) ≥ 13 6. Peak urinary flow rate (Qmax) 5-15 mL/sec with minimum voided volume of 125 mL 7. Willing to provide informed consent and comply with protocol required follow-up Exclusion Criteria: 1. Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and utilize a highly effective contraceptive for at least 12 months post-procedure 2. Presence of an artificial urinary sphincter, penile prosthesis, or stent(s) in the urethra or prostate 3. Any prior minimally invasive intervention (e.g., TUNA, Balloon, Microwave, Rezūm, UroL