Implantable sphincter offers hope for Post-Surgery leakage

NCT ID NCT04088331

First seen Jun 24, 2026 · Last updated Jun 24, 2026

Summary

This completed trial tested the AMS 800 artificial urinary sphincter in 145 men with stress urinary incontinence after prostate surgery. The device is implanted to mimic natural bladder control. Researchers measured how many men had at least a 50% reduction in urine leakage after 12 months, and tracked safety issues like device revisions or serious side effects.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for STRESS URINARY INCONTINENCE are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

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 provide a reliable, long-term option for men to regain urinary control after prostate surgery.

What could go wrong

This is a completed device study, not a cure. Risks include infection, device malfunction, or need for revision surgery. Results may not apply to all patients.

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.