Can a Drug-Coated balloon ease an enlarged prostate without surgery?

NCT ID NCT04131907

Ongoing Symptom relief Sponsor: Urotronic Inc. Source: ClinicalTrials.gov ↗

First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This trial tests a device called the Optilume BPH Catheter System, a balloon coated with the drug paclitaxel that is inflated inside the prostate to widen the urinary passage. The study enrolls men aged 50 to 80 with moderate to severe BPH symptoms who have not responded well to medication. Half receive the active device and half a sham procedure to see if the treatment safely improves urine flow and symptom scores.

What this could mean

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

Active substance: a drug-coated balloon catheter called Optilume BPH Catheter System that dilates the prostatic urethra and releases paclitaxel
What this could lead to: If it works, this could offer a minimally invasive, one-time procedure to relieve bothersome urinary symptoms from an enlarged prostate without daily medication.
What could go wrong: This is an early-stage device trial with a sham control, so benefits may be modest or no better than placebo. Risks include serious complications like fistula, bleeding, or urinary retention.

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.

benign prostatic hyperplasia Color Vision Defects

As listed by the trial registrant

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

BENIGN PROSTATIC HYPERPLASIA

Contacts and locations

Locations

AccuMed Research Associates

Garden City, New York, 11530, United States
Advanced Urology Institute

Daytona Beach, Florida, 32114, United States
Arkansas Urology

Little Rock, Arkansas, 72211, United States
Associated Urologists of NC

Raleigh, North Carolina, 27612, United States
Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States
Chesapeake Urology Research Associates

Hanover, Maryland, 21076, United States
Chesapeake Urology Research Associates

Towson, Maryland, 21204, United States
Clear Lake Specialties

Webster, Texas, 77598, United States
Colorado Clinical Research

Golden, Colorado, 80401, United States
Comprehensive Urologic Care

Lake Barrington, Illinois, 60010, United States
Florida Urology Partners

Tampa, Florida, 33615, United States
Manhattan Medical Research Practice, PLLC

New York, New York, 10016, United States
New Jersey Urology

Englewood, New Jersey, 07631, United States
North Austin Urology

Austin, Texas, 78750, United States
Regional Urology, LLC

Shreveport, Louisiana, 71106, United States
Rio Grande Urology

El Paso, Texas, 79912, United States
Sheldon Freedman MD, Ltd

Las Vegas, Nevada, 89144, United States
University Urology Associates

Toronto, Ontario, M5G 1E2, Canada
University of Montreal Hospital Center (CHUM)

Montreal, Quebec, H2X 3E4, Canada
Urology Austin, PLLC

Austin, Texas, 78745, United States
Weill Cornell Medical College

New York, New York, 10065, United States

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