Overview
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.
Description
Male subject diagnosed with a stricture in the anterior urethra that can be treated with the Optilume Urethral DCB. Thirty-Four (34) subjects will be enrolled at up to ten (10) sites in the United States. Clinical follow-up will be conducted at 30 days, 3 months, 6 months, and 12 months post-treatment evaluating Lower Urinary Tract Symptoms (LUTS), sexual function, and voiding function. Semen quality parameters will be assessed at Baseline, 3 months, and 6 months post-treatment. Subjects with an abnormal semen quality result at 6 months will have an additional assessment at 12 months post-treatment and periodically thereafter until results return to normal.
Eligibility
Inclusion Criteria:
- 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%
Exclusion Criteria:
- Subjects with a known hypersensitivity to paclitaxel or structurally related compounds
- Subjects with a history of vasectomy or other condition that may inhibit semen/sperm production or ejaculatory function
- Subjects currently taking 5-alpha reductase inhibitors, alpha-blockers, selective serotonin reuptake inhibitors, or hormone replacement therapy without appropriate washout
- Subject is unwilling to abstain or utilize a condom for 30 days after the procedure
- Subject is unwilling to utilize highly effective contraception for 6 months after the procedure if partner is of childbearing potential
- History of cancer in any body system that is not considered in complete remission
