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Artificial Urinary Sphincter

AMS 800 Artificial Urinary Sphincter Recipients for Stress Incontinence (AUSCO Trial)

N/A
Waitlist Available
Led By Melissa Kaufman, MD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 6 months and 12 months
Awards & highlights

Summary

This trial is testing the AMS 800 Artificial Urinary Sphincter in men with primary stress urinary incontinence. The device is meant to help with incontinence by giving the person more control over their urinary functions. The trial will use pad weight tests to measure the success of the device.

Eligible Conditions
  • Stress Incontinence

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months, 6 months and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of subjects with reduction in 24 hour pad weight test at 12 months
Secondary outcome measures
Incidence of safety parameters
Number of pads per day
Number of subjects achieving ≥ 50% reduction in 24 hour pad weight test at 6 months
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: AMS 800 Artificial Urinary Sphincter RecipientsExperimental Treatment1 Intervention
Adult males with moderate to severe primary stress urinary incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications for surgical correction of urinary incontinence.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AMS 800 Artificial Urinary Sphincter
2019
N/A
~150

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Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
737 Previous Clinical Trials
854,092 Total Patients Enrolled
Melissa Kaufman, MDPrincipal InvestigatorVanderbilt Urology
~24 spots leftby Sep 2025
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