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Artificial Urinary Sphincter Clinical Outcomes

NCT04088331 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 145

Last updated 2026-01-14

Study results available
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Summary

To evaluate the AMS 800 Artificial Urinary Sphincter (AUS) in men with primary stress urinary incontinence as measured by pad weight tests.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

AMS 800 Artificial Urinary Sphincter

The AMS 800 Artificial Urinary Sphincter (AUS) is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence due to reduced urethral/bladder outlet resistance (intrinsic sphincter deficiency). It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra under the control of the patient.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Melissa Kaufman, MD · Vanderbilt Urology

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-14
Primary Completion
2024-05-13
Completion
2024-05-13

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04088331 on ClinicalTrials.gov