Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

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 betreated with the Optilume Urethral DCB in accordance with the approved Instructionsfor Use

3. Subject is willing to provide written informed consent and comply with studyrequired follow-up assessments

4. Subject able to provide viable semen samples and baseline semen qualitycharacteristics are above reference values based on below criteria (average of 2samples):

5. total sperm ≥39 million

6. sperm concentration ≥15 million/mL

7. total motility ≥40%

8. progressive motility ≥32%

9. morphology ≥4%

Exclusion Criteria:

1. Subjects with a known hypersensitivity to paclitaxel or structurally relatedcompounds

2. Subjects with a history of vasectomy or other condition that may inhibit semen/spermproduction or ejaculatory function

3. Subjects currently taking 5-alpha reductase inhibitors, alpha-blockers, selectiveserotonin reuptake inhibitors, or hormone replacement therapy without appropriatewashout

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 afterthe procedure if partner is of childbearing potential

6. History of cancer in any body system that is not considered in complete remission