New balloon treatment for urethral stricture under scrutiny for sperm safety

NCT ID NCT05383274

Recruiting now Disease control Sponsor: Urotronic Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a special balloon coated with the drug paclitaxel, called Optilume, used to open narrowed areas in the urethra. Researchers want to see if it affects semen quality in men aged 22 to 65. The trial will measure changes in sperm concentration over 3 to 6 months in 34 participants.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: paclitaxel-coated balloon
What this could lead to: If successful, this could show that Optilume is safe for semen quality, offering a treatment option for urethral stricture without harming fertility.
What could go wrong: This is a small, single-arm study with only 34 men, so results may not apply widely. The drug paclitaxel could affect sperm, and long-term effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

urethral stricture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

URETHRAL STRICTURE

Contacts and locations

Locations

Arkansas Urology
RECRUITING

Little Rock, Arkansas, 72211, United States
Chesapeake
COMPLETED

Hanover, Maryland, 21076, United States
Florida Urology
RECRUITING

Tampa, Florida, 33615, United States
Freedman Urology
RECRUITING

Las Vegas, Nevada, 89144, United States
New Jersey Urolgy
COMPLETED

Millburn, New Jersey, 07041, United States
Orlando Health
RECRUITING

Orlando, Florida, 32806, United States
Regional Urology
COMPLETED

Shreveport, Louisiana, 71106, United States
Urology Clinics of North Texas
RECRUITING

Dallas, Texas, 75231, United States
Western New York
RECRUITING

Cheektowaga, New York, 14225, United States

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