New balloon catheter aims to relieve prostate troubles

NCT ID NCT06312722

First seen Jun 26, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study tests the Optilume BPH Catheter System, a device with a drug-coated balloon that opens the prostate to improve urine flow. About 92 men aged 50 and older with moderate to severe symptoms will be treated. Researchers will check if symptoms improve and track any serious side effects over 12 months.

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 catheter
What this could lead to
If successful, this could offer a minimally invasive option to relieve urinary symptoms caused by an enlarged prostate.
What could go wrong
This is a small, post-market study with no control group, so results may not apply to everyone. Risks include serious side effects like urinary retention or bleeding.

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.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Arkansas Urology

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Florida Urology Partners, LLP

    RECRUITING

    Tampa, Florida, 33615, United States

  • Houston Methodist Urology Associates

    RECRUITING

    Houston, Texas, 77030, United States

  • Midtown Urology Associates

    RECRUITING

    Austin, Texas, 78705, United States

  • Ochsner LSU Health Shreveport - Regional Urology

    RECRUITING

    Shreveport, Louisiana, 71106, United States

  • Oregon Urology Institute

    RECRUITING

    Springfield, Oregon, 97477, United States

  • Sheldon Freedman MD, Ltd

    RECRUITING

    Las Vegas, Nevada, 89144, United States

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