Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study

The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System. STUDY ENDPOINTS Primary Efficacy Endpoint: The primary efficacy endpoint is the average IPSS improvement from baseline to 12 months. Primary Safety Endpoint: The primary safety endpoint is the freedom from composite treatment-related adverse SAEs. Key Secondary Safety Endpoint (Semen Sub-Study Only): The average change from baseline in sperm concentration at 13 weeks (3 months) post-procedure will be compared against a performance goal of -30% (30% decrease from base…