A Prospective Multi-site Registry of Real-world Experience With the OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH
Urotronic Inc.
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
- Age range
- Not specified
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1\. Patients treated with the Optilume BPH Catheter System in accordance with the Instructions for Use (IFU). 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. Confirmed or suspected malignancy of prostate or bladder. 4. Active urinary tract infection (UTI) 5. Anatomy (e.g., presence of false passage or size of meatus) is…
Interventions
- OtherData collection
Subject's data will be collected from patients that are undergoing care using the Optilume drug-coated catheter system.
Locations (9)
- Golden State UrologySacramento, California
- Florida Urology PartnersTampa, Florida
- Kearney Urology CenterKearney, Nebraska
- The Urology Center, P.C.Omaha, Nebraska
- Sheldon Freedman, LtdLas Vegas, Nevada
- Northwell Health - Smith Institute of UrologySyosset, New York