NCT04088331

Artificial Urinary Sphincter Clinical Outcomes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 145 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Study is designed to evaluate the performance of 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

Type	Name	Description
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.

Timeline

• Start date: 2019-10-14
• Primary completion: 2024-05-13
• Completion: 2024-05-13
• First posted: 2019-09-12
• Last updated: 2026-01-14
• Results posted: 2025-08-03

Locations

18 sites across 2 countries: United States, Australia