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
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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.
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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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Academic Urology and Urogynecology of Arizona
Phoenix, Arizona, 85027, United States
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Adult & Pediatric Urology, PC
Omana, Nebraska, 68114, United States
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Advanced Urology Institute
Daytona Beach, Florida, 32114, United States
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Arkansas Urology
Little Rock, Arkansas, 72211, United States
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Carolina Urology Partners
Concord, North Carolina, 28025, United States
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Chesapeake Urology
Hanover, Maryland, 21076, United States
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Chesapeake Urology Research
Annapolis, Maryland, 21401, United States
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Columbia University Medical Center/New York-Presbyterian Hospital
New York, New York, 10032, United States
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Integrated Medical Professionals OBP
North Hills, New York, 11042, United States
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Iris Cantor Men's Health Center
New York, New York, 10065, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Minnesota Urology
Woodbury, Minnesota, 55125, United States
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New Jersey Urology
Voorhees Township, New Jersey, 08043, United States
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Oregon Urology Institute
Springfield, Oregon, 97477, United States
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Royal Victoria Hospital, Glen Site
Montreal, Quebec, H4A 3J1, Canada
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UT Southwestern
Dallas, Texas, 75390, United States
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University of Iowa
Iowa City, Iowa, 52242, United States
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University of Minnesota Department of Urology
Minneapolis, Minnesota, 55445, United States
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University of Washington Harborview Medical Center
Seattle, Washington, 98104, United States
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Urology San Antonio
San Antonio, Texas, 78229, United States
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Urology of Virginia
Virginia Beach, Virginia, 23462, United States
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Western New York Urology Associates
Cheektowaga, New York, 14225, United States