OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH
Purpose
APEX is a prospective multi-site registry of real-world experience with the Optilume™ BPH Catheter System for treatment of men experiencing symptomatic BPH.
Condition
- Benign Prostatic Hyperplasia
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patients treated with the Optilume BPH Catheter System in accordance with the Instructions for Use (IFU).
Exclusion Criteria
- 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 not suitable for treatment with the Optilume BPH Catheter System
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Case-Control
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Study Arm | This is the data collection study arm. There is no other arm in the study. |
|
Recruiting Locations
Golden State Urology
Sacramento, California 95823
Sacramento, California 95823
Kearney Urology Center
Kearney, Nebraska 68847
Kearney, Nebraska 68847
Adult & Pediatric Urology, PC
Omaha, Nebraska 68144
Omaha, Nebraska 68144
Sheldon Freedman, Ltd
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Northwell Health - Smith Institute of Urology
Syosset, New York 11791
Syosset, New York 11791
More Details
- NCT ID
- NCT06560476
- Status
- Recruiting
- Sponsor
- Urotronic Inc.