Actively Recruiting
Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Led by Urotronic Inc. · Updated on 2026-04-28
34
Participants Needed
9
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
Urotronic Inc.
Lead Sponsor
L
Laborie Medical Technologies Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research evaluates semen quality after treatment with the Optilume Urethral Drug Coated Balloon (DCB) in men aged 22 to 65 who have an anterior urethral stricture treatable with this device. It is a single-arm, prospective study involving 34 male participants across multiple sites in the United States. The study aims to assess various urinary and sexual function outcomes following treatment. Participants receive the Optilume Urethral DCB, a catheter with a balloon coated with the drug paclitaxel that transfers the medication to the urethral wall upon inflation. The study includes follow-up visits at 30 days, 3 months, 6 months, and 12 months after treatment to monitor symptoms and function. Semen quality is tested before treatment and at 3 and 6 months post-treatment, with additional testing up to 12 months if abnormalities are detected. During the study, participants undergo evaluations of urinary symptoms, sexual function, and voiding function at scheduled intervals. Semen samples are collected to assess sperm characteristics. Safety endpoints are reviewed at 3 and 6 months. Follow-up continues for up to a year or longer if semen abnormalities persist, ensuring comprehensive monitoring of treatment effects and participant well-being.
CONDITIONS
Brief Title
Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subjects between 22 and 65 years of age
- Diagnosed with a stricture in the anterior urethra treatable with the Optilume Urethral DCB
- Willing to provide written informed consent and comply with follow-up assessments
- Able to provide viable semen samples with baseline quality above reference values including total sperm ≥39 million, concentration ≥15 million/mL, total motility ≥40%, progressive motility ≥32%, and morphology ≥4%
You will not qualify if you...
- Known hypersensitivity to paclitaxel or related compounds
- History of vasectomy or conditions that inhibit semen or sperm production or ejaculatory function
- Currently taking certain medications like 5-alpha reductase inhibitors, alpha-blockers, SSRIs, or hormone therapy without proper washout
- Unwilling to abstain or use a condom for 30 days after the procedure
- Unwilling to use highly effective contraception for 6 months if partner could become pregnant
- History of cancer not in complete remission
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 - Single procedure with follow-up assessments up to 12 months
Participants receive the Optilume Urethral Drug Coated Balloon (DCB) treatment for their anterior urethral stricture.
1 treatment visit and follow-up visits at 30 days, 3 months, 6 months, and 12 months post-treatment
Duration - Up to 12 months post-treatment with periodic assessments thereafter if needed
Participants are monitored for Lower Urinary Tract Symptoms, sexual function, voiding function, and semen quality at specified intervals. Additional semen quality assessments occur if abnormalities are detected at 6 months.
Follow-up visits at 30 days, 3 months, 6 months, 12 months, and additional visits as needed for semen quality monitoring
Trial Site Locations
Total: 9 locations
1
Arkansas Urology
Little Rock, Arkansas, United States, 72211
Actively Recruiting
2
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
3
Florida Urology
Tampa, Florida, United States, 33615
Actively Recruiting
4
Regional Urology
Shreveport, Louisiana, United States, 71106
Completed
5
Chesapeake
Hanover, Maryland, United States, 21076
Completed
6
Freedman Urology
Las Vegas, Nevada, United States, 89144
Actively Recruiting
7
New Jersey Urolgy
Millburn, New Jersey, United States, 07041
Completed
8
Western New York
Cheektowaga, New York, United States, 14225
Actively Recruiting
9
Urology Clinics of North Texas
Dallas, Texas, United States, 75231
Actively Recruiting
Research Team
B
Brenda Johnson, MS
R
Reem Ennenga
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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