Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

Eligibility 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%
• 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