CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 145 enrolled
Drug / intervention
AMS 800 Artificial Urinary Sphincterdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04088331
NCT04088331N/ACompleted
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Artificial Urinary Sphincter Clinical Outcomes

Boston Scientific Corporation·observational·Posted Sep 12, 2019·Updated Jan 14, 2026

In Brief

An observational study evaluating AMS 800 Artificial Urinary Sphincter for Stress Urinary Incontinence. Completed, enrolled 145 participants across 18 sites in 2 countries.

Detailed Summary

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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsStress Urinary Incontinence
CountriesAustralia, United States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 12, 2019
Enrollment StartOct 14, 2019
Primary CompletionMay 13, 2024
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 6.8 years ago

Interventions

AMS 800 Artificial Urinary Sphincterdevice

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.