RecruitingUrethral Stricture
Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Eligible age
22–65 yrs
Accepts
Men
Locations
8 states
Healthy volunteers
No
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About this study
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.
Sponsor: Urotronic Inc.
You may qualify if…
- ✓ 1. Male subjects between 22 and 65 years of age
- ✓ 2. Subject diagnosed with a stricture in the anterior urethra that is able to be treated with the Optilume Urethral DCB in accordance with the approved Instructions for Use
- ✓ 3. Subject is willing to provide written informed consent and comply with study required follow-up assessments
- ✓ 4. Subject able to provide viable semen samples and baseline semen quality characteristics are above reference values based on below criteria (average of 2 samples):
- ✓ 1. total sperm ≥39 million
- ✓ 2. sperm concentration ≥15 million/mL
- ✓ 3. total motility ≥40%
- ✓ 4. progressive motility ≥32%
You may not qualify if…
- ✕ 1. Subjects with a known hypersensitivity to paclitaxel or structurally related compounds
- ✕ 2. Subjects with a history of vasectomy or other condition that may inhibit semen/sperm production or ejaculatory function
- ✕ 3. Subjects currently taking 5-alpha reductase inhibitors, alpha-blockers, selective serotonin reuptake inhibitors, or hormone replacement therapy without appropriate washout
- ✕ 4. Subject is unwilling to abstain or utilize a condom for 30 days after the procedure
- ✕ 5. Subject is unwilling to utilize highly effective contraception for 6 months after the procedure if partner is of childbearing potential
- ✕ 6. History of cancer in any body system that is not considered in complete remission
Where it's recruiting
Source: ClinicalTrials.gov · NCT05383274 · last updated 2026-04-28