Artificial Urinary Sphincter Clinical Outcomes

Boston Scientific Corporation18 sites in 2 countries145 target enrollmentOctober 14, 2019

ConditionsStress Urinary Incontinence

InterventionsAMS 800 Artificial Urinary Sphincter

Overview

Phase: Not Applicable
Intervention: AMS 800 Artificial Urinary Sphincter
Conditions: Stress Urinary Incontinence
Sponsor: Boston Scientific Corporation
Enrollment: 145
Locations: 18
Primary Endpoint: Number of Subjects With Reduction in 24 Hour Pad Weight Test at 12 Months
Status: Completed
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 14, 2019

End Date

May 13, 2024

Last Updated

3 months ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•≥ 18 years of age
•Has undergone either a radical prostatectomy, transurethral resection of the prostate or other invasive prostate surgery
•Demonstrates primary stress urinary incontinence
•Positive screening 24-hour pad weight test (≥100 grams)
•Experiences at least 3 incontinence episodes per day during baseline diary or presents with continuous incontinence
•Negative urine culture
•Willing and able to undergo surgical implantation of the AUS device
•Willing and able to comply with the follow-up requirements
•Willing and able to forego any other surgical urinary incontinence treatments while participating in the study
•Willing and able to sign the informed consent

Exclusion Criteria

•Previously had or currently has a device implanted (AUS/Sling, or otherwise) for treatment of SUI or urge incontinence
•Primary urgency incontinence
•Postvoid residual volume greater that 150 ml or a history of difficulty emptying the bladder
•Recurrent vesicourethral anastomotic stricture or urethral stricture disease within the past 6 months
•Known urogenital malignancy other than previously treated prostate cancer
•Recurrent prostate cancer that is expected to require intervention during the study follow-up period
•History of recurrent bladder stones within the past 12 months prior to signing the informed consent
•Neurogenic bladder
•Need for intermittent catheterization
•Known history of bleeding diathesis or coagulopathy

Arms & Interventions

AMS 800 Artificial Urinary Sphincter Recipients

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.

Intervention: AMS 800 Artificial Urinary Sphincter

Outcomes

Primary Outcomes

Number of Subjects With Reduction in 24 Hour Pad Weight Test at 12 Months

Time Frame: 12 months

Number of subjects achieving 50% reduction or greater in baseline urinary incontinence as measured by 24-hour pad weight test at 12 months post device activation

Secondary Outcomes

Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related(3 months, 6 months, and 12 months)
Number of Subjects Achieving ≥ 50% Reduction in 24 Hour Pad Weight Test at Device Activation(Device Activation)
Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at Device Activation(Device Activation)
Change in Number of Pads Per Day at 6 Months(6 months)
Change in Number of Pads Per Day at 3 Months(3 months)
Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at 6 Months(6 months)
Number of Subjects Achieving ≥ 50% Reduction in 24 Hour Pad Weight Test at 6 Months(6 months)
Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at 12 Months(12 months)
Change in Number of Pads Per Day at 12 Months(12 months)