Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Trial Parameters
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Brief Summary
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.
Eligibility Criteria
Inclusion Criteria: 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% 5. morphology ≥4% Exclusion Criteria: 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