New balloon could ease urinary blockages without surgery

NCT ID NCT03499964

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a special balloon coated with the drug paclitaxel to treat urethral stricture, a narrowing of the urine tube in men. The balloon is inflated to open the stricture and deliver the drug to prevent it from closing again. The trial involves 127 men who have had at least two prior treatments, comparing the drug-coated balloon to standard dilation or incision. The goal is to see if the balloon keeps the urethra open longer and improves urine flow.

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 (Optilume Drug Coated Balloon)

What this could lead to

If successful, this could offer a less invasive, longer-lasting treatment for urethral stricture, reducing the need for repeat surgeries.

What could go wrong

This is a mid-stage trial with 127 participants, so results may not apply to all patients. The balloon uses a drug (paclitaxel) that has risks, and the device may not work better than standard treatments.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

Bites and Stings Lower Urinary Tract Symptoms urethral stricture

As listed by the trial registrant

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

Contacts and locations

Locations

  • Academic Urology and Urogynecology of Arizona

    Phoenix, Arizona, 85027, United States

  • Adult & Pediatric Urology, PC

    Omana, Nebraska, 68114, United States

  • Advanced Urology Institute

    Daytona Beach, Florida, 32114, United States

  • Arkansas Urology

    Little Rock, Arkansas, 72211, United States

  • Carolina Urology Partners

    Concord, North Carolina, 28025, United States

  • Chesapeake Urology

    Hanover, Maryland, 21076, United States

  • Chesapeake Urology Research

    Annapolis, Maryland, 21401, United States

  • Columbia University Medical Center/New York-Presbyterian Hospital

    New York, New York, 10032, United States

  • Integrated Medical Professionals OBP

    North Hills, New York, 11042, United States

  • Iris Cantor Men's Health Center

    New York, New York, 10065, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Minnesota Urology

    Woodbury, Minnesota, 55125, United States

  • New Jersey Urology

    Voorhees Township, New Jersey, 08043, United States

  • Oregon Urology Institute

    Springfield, Oregon, 97477, United States

  • Royal Victoria Hospital, Glen Site

    Montreal, Quebec, H4A 3J1, Canada

  • UT Southwestern

    Dallas, Texas, 75390, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Minnesota Department of Urology

    Minneapolis, Minnesota, 55445, United States

  • University of Washington Harborview Medical Center

    Seattle, Washington, 98104, United States

  • Urology San Antonio

    San Antonio, Texas, 78229, United States

  • Urology of Virginia

    Virginia Beach, Virginia, 23462, United States

  • Western New York Urology Associates

    Cheektowaga, New York, 14225, United States