Actively Recruiting
A Prospective Multi-site Registry of Real-world Experience With the Optilume213; BPH Catheter System for Treatment of Men Experiencing Symptomatic BPH
Led by Urotronic Inc. · Updated on 2026-03-27
500
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting real-world data on the use of the Optilume™ BPH Catheter System to treat men with symptomatic benign prostatic hyperplasia (BPH). This observational study monitors men who have received this treatment to understand its effects and safety in everyday clinical practice. The study is sponsored by Urotronic Inc. and aims to gather information on patient outcomes over time. Participants are men treated with the Optilume drug-coated catheter system according to its instructions for use. There is only one study group involved, and the focus is on collecting data from these patients as they receive standard care. No additional treatments or placebo groups are involved in this registry study. During the study, researchers will track changes in symptom scores using the International Prostate Symptom Score (IPSS) from baseline to 12 months, and monitor safety by recording any treatment-related serious adverse events. Additional measures include symptom severity, urinary flow rates, residual urine volume, and the need for repeat interventions over an average follow-up of 2 years. Data collection will continue throughout this period to provide insights into the treatment's real-world performance and safety.
CONDITIONS
Brief Title
OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients treated with the Optilume BPH Catheter System following the Instructions for Use (IFU)
You will not qualify if you...
- Unwilling to abstain from sexual intercourse or use a condom for 30 days after the procedure and to use effective contraception for at least 12 months after
- Have an artificial urinary sphincter, penile prosthesis, or stent(s) in the urethra or prostate
- Have confirmed or suspected prostate or bladder cancer
- Have an active urinary tract infection
- Have anatomy unsuitable for treatment with the Optilume BPH Catheter System (e.g., false passage or small meatus)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants who undergo routine care with the Optilume BPH Catheter System are observed over time to assess safety and efficacy outcomes.
Regular visits to collect data up to 2 years
Trial Site Locations
Total: 9 locations
1
Golden State Urology
Sacramento, California, United States, 95823
Withdrawn
2
Florida Urology Partners
Tampa, Florida, United States, 33615
Actively Recruiting
3
Kearney Urology Center
Kearney, Nebraska, United States, 68847
Actively Recruiting
4
The Urology Center, P.C.
Omaha, Nebraska, United States, 68144
Completed
5
Sheldon Freedman, Ltd
Las Vegas, Nevada, United States, 89144
Actively Recruiting
6
Northwell Health - Smith Institute of Urology
Syosset, New York, United States, 11791
Actively Recruiting
7
Good Samaritan Hospital
Corvallis, Oregon, United States, 97330
Completed
8
Midtown Urology
Austin, Texas, United States, 78705
Actively Recruiting
9
Potomac Urology
Woodridge, Virginia, United States, 22191
Completed
Research Team
K
Kaitlyn Palm
R
Reem Ennenga
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here