Evaluation of semen quality after urethral stricture treatment
Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
This study is testing how a new treatment for urethral stricture affects semen quality in men aged 22 to 65 over six months.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 22 Years to 65 Years |
| Sex | Male |
| Sponsor | Urotronic Inc. Industry-sponsored |
| Locations | 9 sites (Little Rock, Arkansas and 8 other locations) |
| Trial ID | NCT05383274 on ClinicalTrials.gov |
What this trial studies
This is a single-arm, prospective study that evaluates semen quality in men aged 22 to 65 years who have been diagnosed with anterior urethral stricture and treated with the Optilume Urethral Drug-Coated Balloon (DCB). A total of 34 subjects will be enrolled across up to ten sites in the United States. Participants will undergo clinical follow-up at various intervals post-treatment to assess lower urinary tract symptoms, sexual function, and voiding function, with semen quality evaluated at baseline, 3 months, and 6 months after treatment. Additional assessments will be conducted for those with abnormal semen quality results at 6 months.
Who should consider this trial
Good fit: Ideal candidates are men aged 22 to 65 with anterior urethral stricture who can provide viable semen samples and meet specific semen quality criteria.
Not a fit: Patients with a history of vasectomy or conditions that inhibit semen production or ejaculatory function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve semen quality and overall reproductive health in men undergoing treatment for urethral stricture.
How similar studies have performed: While similar studies have explored the effects of urethral treatments on urinary function, this specific evaluation of semen quality post-treatment is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Little Rock, Arkansas and 8 other locations
- Arkansas Urology — Little Rock, Arkansas, United States (Recruiting)
- Orlando Health — Orlando, Florida, United States (Recruiting)
- Florida Urology — Tampa, Florida, United States (Recruiting)
- Regional Urology — Shreveport, Louisiana, United States (Completed)
- Chesapeake — Hanover, Maryland, United States (Completed)
- Freedman Urology — Las Vegas, Nevada, United States (Recruiting)
- New Jersey Urolgy — Millburn, New Jersey, United States (Completed)
- Western New York — Cheektowaga, New York, United States (Recruiting)
- Urology Clinics of North Texas — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Karl Coutinho, MD — New Jersey Urology
- Study coordinator: Brenda Johnson, MS
- Email: bjohnson@laborie.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.