New sphincter implant shows promise for Post-Prostate surgery leakage

NCT ID NCT04088331

Completed Disease control Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

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.

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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.

STRESS URINARY INCONTINENCE

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

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