Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

Launched by UROTRONIC INC. · May 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how a specific treatment called the Optilume Urethral Drug-Coated Balloon (DCB) affects semen quality in men who have a condition known as urethral stricture, which is a narrowing of the urethra. The study is looking for male participants aged 22 to 65 who have been diagnosed with this condition and can provide viable semen samples that meet certain quality standards. Participants will need to give their consent and agree to follow-up assessments after the treatment.

To be eligible, men must have a good baseline semen quality, meaning their sperm counts and motility (how well the sperm move) meet specific criteria. However, those with certain medical histories, such as a previous vasectomy or specific allergies, may not qualify. Participants will be asked to refrain from certain medications and to use contraception for a period after the procedure to ensure safety. This trial is currently recruiting participants, and it aims to gather important information about how this treatment impacts male reproductive health.

Gender

MALE

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, 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