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.
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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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Contacts and locations
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Locations
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Australian Urology Associates
Melbourne, Victoria, 3144, Australia
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Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
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Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
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Duke University Medical Center
Durham, North Carolina, 27710, United States
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Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
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Lahey Clinic Hospital
Burlington, Massachusetts, 01805, United States
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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The Methodist Hospital Research Institute
Houston, Texas, 77030, United States
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University of California, San Francisco
San Francisco, California, 94110, United States
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University of Colorado Hospital
Aurora, Colorado, 80045, United States
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University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
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University of Kansas Hospital
Kansas City, Kansas, 66160-7234, United States
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University of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
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University of Utah
Salt Lake City, Utah, 84132, United States
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Urology San Antonio Research, PA.
San Antonio, Texas, 78229, United States
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Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
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Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27103, United States
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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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.