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Completed

NCT Number: NCT04088331

Artificial Urinary Sphincter Clinical Outcomes

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Concord Repatriation General Hospital, Concord, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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
  • 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
  • Poor candidate for surgical procedures and/or anesthesia due to physical or mental conditions
  • Urinary incontinence due to or complicated by an irreversibly obstructed lower urinary tract
  • Irresolvable detrusor hyperreflexia or bladder instability
  • Currently enrolled or plans to enroll in another device or drug clinical trial
  • 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
  • Known allergy or sensitivity to rifampin or to minocycline HCl or other tetracyclines (only applicable when implanting with InhibiZone version of this device)
  • Systemic lupus erythematosus because minocycline HCl has been reported to aggravate this condition (only applicable when implanting with InhibiZone version of this device)

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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. 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

  7. 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

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: AUSCO

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Sep 12, 2019
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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