New sphincter implant shows promise for Post-Prostate surgery leakage

NCT ID NCT04088331

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested an artificial urinary sphincter implant in 145 men with stress urinary incontinence after prostate surgery. The device is designed to mimic natural bladder control by opening and closing the urethra. Researchers measured how many men had at least a 50% reduction in urine leakage after 12 months. The study also tracked complications and the need for device revisions.

What this could mean

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

Active substance

AMS 800 Artificial Urinary Sphincter (implantable device)

What this could lead to

If successful, this device could offer a reliable, long-term way to control urinary leakage in men after prostate surgery, improving quality of life.

What could go wrong

The device requires surgery to implant and may need revision or cause complications like infection or device malfunction. Results may not apply to all men with incontinence.

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.

female stress incontinence Urinary Incontinence, Stress

As listed by the trial registrant

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

Contacts and locations

Locations

  • Australian Urology Associates

    Melbourne, Victoria, 3144, Australia

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139, Australia

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Lahey Clinic Hospital

    Burlington, Massachusetts, 01805, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • The Methodist Hospital Research Institute

    Houston, Texas, 77030, United States

  • University of California, San Francisco

    San Francisco, California, 94110, United States

  • University of Colorado Hospital

    Aurora, Colorado, 80045, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Kansas Hospital

    Kansas City, Kansas, 66160-7234, United States

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

  • Urology San Antonio Research, PA.

    San Antonio, Texas, 78229, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27103, United States

  • Willis-Knighton Bossier Medical Center

    Bossier City, Louisiana, 71111, United States