Using the Optilume BPH Catheter System to treat men with benign prostatic hyperplasia
A Prospective Multi-site Registry of Real-world Experience With the OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH
This study is testing how well the Optilume BPH Catheter System works for men with symptoms of benign prostatic hyperplasia to help improve their treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Sex | Male |
| Sponsor | Urotronic Inc. Industry-sponsored |
| Locations | 9 sites (Sacramento, California and 8 other locations) |
| Trial ID | NCT06560476 on ClinicalTrials.gov |
What this trial studies
This observational study is a prospective multi-site registry that collects real-world data on the effectiveness of the Optilume BPH Catheter System for treating men with symptomatic benign prostatic hyperplasia (BPH). Patients treated with this catheter system will be monitored to assess outcomes and experiences. The study aims to gather valuable information that can help improve treatment protocols for BPH. Data collection will focus on patient-reported outcomes and clinical effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are men experiencing symptoms of benign prostatic hyperplasia who are treated with the Optilume BPH Catheter System.
Not a fit: Patients with certain conditions such as malignancies, urinary tract infections, or anatomical issues unsuitable for the catheter system may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into a new treatment option for men suffering from BPH, potentially improving their quality of life.
How similar studies have performed: While this specific approach is novel, similar studies involving catheter systems for BPH treatment have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 not suitable for treatment with the Optilume BPH Catheter System
Where this trial is running
Sacramento, California and 8 other locations
- Golden State Urology — Sacramento, California, United States (Withdrawn)
- Florida Urology Partners — Tampa, Florida, United States (Recruiting)
- Kearney Urology Center — Kearney, Nebraska, United States (Recruiting)
- The Urology Center, P.C. — Omaha, Nebraska, United States (Completed)
- Sheldon Freedman, Ltd — Las Vegas, Nevada, United States (Recruiting)
- Northwell Health - Smith Institute of Urology — Syosset, New York, United States (Recruiting)
- Good Samaritan Hospital — Corvallis, Oregon, United States (Completed)
- Midtown Urology — Austin, Texas, United States (Recruiting)
- Potomac Urology — Woodridge, Virginia, United States (Completed)
Study contacts
- Study coordinator: Kaitlyn Palm
- Email: kpalm@laborie.com
- Phone: 6128160068
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.