Artificial Urinary Sphincter Clinical Outcomes

NCT04088331 | Completed Results

• 1 other identifier: U0669
• Study Type: observational
• Target: 145
• Locations: 2 countries
• Sites: 18

Brief Summary

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

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Reduction in 24 Hour Pad Weight Test at 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 Outcomes (9)

• 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 3 Months

  3 months

• Number of Subjects Achieving ≥ 50% Reduction in 24 Hour Pad Weight Test at 6 Months

  6 months

Study Arms (1)

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

Interventions

AMS 800 Artificial Urinary Sphincter DEVICE

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.

AMS 800 Artificial Urinary Sphincter Recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male
• ≥ 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

You may not qualify if:

• 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
• Immunosuppressed or on medical therapy which would impact the immune system
• Uncontrolled diabetes, defined as (HbA1c\>10)
• Has a genitourinary mechanical prosthesis that was implanted within 3 months from the date of consent
• Had a post-implantation infection associated with the device after genitourinary mechanical prosthesis was implanted
• Undergone bulking procedure within 6 months of the baseline assessment

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (18)

University of California, San Francisco

San Francisco, California, 94110, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160-7234, United States

Location

Willis-Knighton Bossier Medical Center

Bossier City, Louisiana, 71111, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Lahey Clinic Hospital

Burlington, Massachusetts, 01805, United States

Location

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27103, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

The Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

Urology San Antonio Research, PA.

San Antonio, Texas, 78229, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

Location

Australian Urology Associates

Melbourne, Victoria, 3144, Australia

Location

Related Publications (1)

• Kaufman MR, Wood HM, Terlecki R, Moon D, Myers J, Vanni AJ, Jones L, Broghammer JA, Henry G, Breyer BN, Erickson B, Burnett AL, Johnsen NV, Loong Chan LW, Flynn BJ, Khavari R, Smith TG 3rd, Elliott S, Chaussee EL, Rainbow K, Peterson AC. The Artificial Urinary Sphincter Clinical Outcomes Trial: Primary Results. J Urol. 2026 Feb;215(2):194-202. doi: 10.1097/JU.0000000000004796. Epub 2025 Oct 3.

  PMID: 41042705 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Winnie Chen
• Organization: Boston Scientific

Winnie.Chen@bsci.com

952-930-6000

Study Officials

• Melissa Kaufman, MD

  Vanderbilt Urology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 12, 2019
• Study Start: October 14, 2019
• Primary Completion: May 13, 2024
• Study Completion: May 13, 2024
• Last Updated: January 14, 2026
• Results First Posted: August 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); US (16)