Recruiting

Observational Study

Sponsor:

Urotronic Inc.

Code:

NCT05383274

Conditions

Urethral Stricture

Eligibility Criteria

Sex: Male

Age: 22 - 65

Healthy Volunteers: Not accepted

Interventions

Optilume Urethral DCB

Study Details

Brief summary:

Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.

Conditions

Urethral Stricture

Study ID

NCT05383274

Start date

Feb 14, 2022

Status verified date

Apr, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 22 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

34 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Optilume Urethral DCB

The Optilume Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation.

Interventions

Optilume Urethral DCB

The Optilume Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation.

Primary outcome measure

  • Primary Safety Endpoint [ Time Frame: 3-months ]

Central Contacts and Locations

Central contacts

Locations

Arkansas Urology

Recruiting

Little Rock, Arkansas, United States, 72211

Contacts

Orlando Health

Recruiting

Orlando, Florida, United States, 32806

Contacts

Florida Urology

Recruiting

Tampa, Florida, United States, 33615

Contacts

Freedman Urology

Recruiting

Las Vegas, Nevada, United States, 89144

Contacts

Western New York

Recruiting

Cheektowaga, New York, United States, 14225

Contacts

Urology Clinics of North Texas

Recruiting

Dallas, Texas, United States, 75231

Contacts

More Information

Sponsor

Urotronic Inc.

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Urotronic Inc. on 2026-04-28.