Artificial Urinary Sphincter Clinical Outcomes (AUSCO)

December 19, 2025 updated by: Boston Scientific Corporation
To evaluate the AMS 800 Artificial Urinary Sphincter (AUS) in men with primary stress urinary incontinence as measured by pad weight tests.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
145

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3144
        • Australian Urology Associates
  • United States
    • California
      • San Francisco, California, United States, 94110
        • University of California, San Francisco
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160-7234
        • University of Kansas Hospital
    • Louisiana
      • Bossier City, Louisiana, United States, 71111
        • Willis-Knighton Bossier Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States, 27103
        • Wake Forest University School of Medicine
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Md Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • The Methodist Hospital Research Institute
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio Research, PA.
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This study will enroll 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.

Description

Inclusion Criteria:

  1. Male
  2. ≥ 18 years of age
  3. Has undergone either a radical prostatectomy, transurethral resection of the prostate or other invasive prostate surgery
  4. Demonstrates primary stress urinary incontinence
  5. Positive screening 24-hour pad weight test (≥100 grams)
  6. Experiences at least 3 incontinence episodes per day during baseline diary or presents with continuous incontinence
  7. Negative urine culture
  8. Willing and able to undergo surgical implantation of the AUS device
  9. Willing and able to comply with the follow-up requirements
  10. Willing and able to forego any other surgical urinary incontinence treatments while participating in the study
  11. Willing and able to sign the informed consent

Exclusion Criteria:

  1. Previously had or currently has a device implanted (AUS/Sling, or otherwise) for treatment of SUI or urge incontinence
  2. Primary urgency incontinence
  3. Postvoid residual volume greater that 150 ml or a history of difficulty emptying the bladder
  4. Recurrent vesicourethral anastomotic stricture or urethral stricture disease within the past 6 months
  5. Known urogenital malignancy other than previously treated prostate cancer
  6. Recurrent prostate cancer that is expected to require intervention during the study follow-up period
  7. History of recurrent bladder stones within the past 12 months prior to signing the informed consent
  8. Neurogenic bladder
  9. Need for intermittent catheterization
  10. Known history of bleeding diathesis or coagulopathy
  11. Immunosuppressed or on medical therapy which would impact the immune system
  12. Uncontrolled diabetes, defined as (HbA1c>10)
  13. Has a genitourinary mechanical prosthesis that was implanted within 3 months from the date of consent
  14. Had a post-implantation infection associated with the device after genitourinary mechanical prosthesis was implanted
  15. Undergone bulking procedure within 6 months of the baseline assessment
  16. Poor candidate for surgical procedures and/or anesthesia due to physical or mental conditions
  17. Urinary incontinence due to or complicated by an irreversibly obstructed lower urinary tract
  18. Irresolvable detrusor hyperreflexia or bladder instability
  19. Currently enrolled or plans to enroll in another device or drug clinical trial
  20. Currently using an indwelling catheter or condom catheter for treatment of incontinence and is not willing to discontinue use at least 4 weeks prior to baseline assessment
  21. Known allergy or sensitivity to rifampin or to minocycline HCl or other tetracyclines (only applicable when implanting with InhibiZone version of this device)
  22. Systemic lupus erythematosus because minocycline HCl has been reported to aggravate this condition (only applicable when implanting with InhibiZone version of this device)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related
Time Frame: 3 months, 6 months, and 12 months
Percentage of Participants that Required Revision (Revision Rates), had Serious Adverse Events, and had Serious Adverse Events that are Device and/or Procedure Related at 3 months, 6 months, and 12 months. Adverse event and revision rates are summarized by the Kaplan-Meier estimate with revision/event timing relative to the index procedure.
3 months, 6 months, and 12 months
Number of Subjects Achieving ≥ 50% Reduction in 24 Hour Pad Weight Test at Device Activation
Time Frame: Device Activation
Number of subjects achieving ≥ 50% reduction in urinary incontinence as measured by 24-hour pad weight test at device activation compared to baseline
Device Activation
Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at Device Activation
Time Frame: Device Activation
≥ 75% reduction in urinary incontinence as measured by 24-hour pad weight test at device activation compared to baseline
Device Activation
Change in Number of Pads Per Day at 3 Months
Time Frame: 3 months
Change in number of pads per day at 3 months compared to baseline. Change was calculated by subtracting the number of pads per day at baseline from the number of pads per day at 3 months.
3 months
Number of Subjects Achieving ≥ 50% Reduction in 24 Hour Pad Weight Test at 6 Months
Time Frame: 6 months
Number of subjects achieving ≥ 50% reduction in urinary incontinence as measured by 24-hour pad weight test at 6 months post device activation compared to baseline
6 months
Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at 6 Months
Time Frame: 6 months
≥ 75% reduction in urinary incontinence as measured by 24-hour pad weight test at 6 months post device activation compared to baseline
6 months
Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at 12 Months
Time Frame: 12 months
≥ 75% reduction in urinary incontinence as measured by 24-hour pad weight test at 12 months post device activation compared to baseline
12 months
Change in Number of Pads Per Day at 6 Months
Time Frame: 6 months
Change in number of pads per day at 6 months post-device activation compared to baseline. Change was calculated by subtracting the number of pads per day at baseline from the number of pads per day at 6 months.
6 months
Change in Number of Pads Per Day at 12 Months
Time Frame: 12 months
Change in number of pads per day at 12 months post-device activation compared to baseline. Change was calculated by subtracting the number of pads per day at baseline from the number of pads per day at 12 months.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Melissa Kaufman, MD, Vanderbilt Urology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 14, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 13, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 13, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • U0669

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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