Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.
• Male subjects between 22 and 65 years of age
• 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
• Subject is willing to provide written informed consent and comply with study required follow-up assessments
• Subject able to provide viable semen samples and baseline semen quality characteristics are above reference values based on below criteria (average of 2 samples):
‣ total sperm ≥39 million
⁃ sperm concentration ≥15 million/mL
⁃ total motility ≥40%
⁃ progressive motility ≥32%
⁃ morphology ≥4%