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NCT05383274PHASE4Recruiting

Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

Urotronic Inc.

Start Date

2/14/2022

Completion Date

12/30/2026

Summary

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

Detailed 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 Criteria

Age Range: 22 years to 65 years

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

Interventions

COMBINATION_PRODUCT

Optilume Urethral DCB

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Conditions

Urethral Stricture

Locations

Arkansas Urology

Little Rock, Arkansas 72211

United States

Orlando Health

Orlando, Florida 32806

United States

Florida Urology

Tampa, Florida 33615

United States

Regional Urology

Shreveport, Louisiana 71106

United States

Chesapeake

Hanover, Maryland 21076

United States

Freedman Urology

Las Vegas, Nevada 89144

United States

New Jersey Urolgy

Millburn, New Jersey 07041

United States

Western New York

Cheektowaga, New York 14225

United States

Urology Clinics of North Texas

Dallas, Texas 75231

United States