OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH

Condition(s) studied

Investigational drug(s) / intervention(s)

Data collection: Subject's data will be collected from patients that are undergoing care using the Optilume drug-coated catheter system.

Study summary

APEX is a prospective multi-site registry of real-world experience with the Optilume™ BPH Catheter System for treatment of men experiencing symptomatic BPH.

Eligibility

Primary outcome measure(s)

• The primary efficacy endpoint is the average IPSS change from baseline to 12 months. — Baseline to 12 months
  The primary efficacy endpoint is the average IPSS change from baseline to 12 months. The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. It is not a reliable diagnostic tool for lower urinary tract symptoms (LUTS) suggestive of BPH, but can be used to quantitatively measure LUTS after a diagnosis is made.
• The primary safety endpoint is the freedom from treatment-related adverse SAEs. — Baseline to 12 months
  The primary safety endpoint is the freedom from treatment-related adverse SAEs.

Trial sites (8)