Artificial Urinary Sphincter Clinical Outcomes (AUSCO)
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ClinicalTrials.gov Identifier: NCT04088331 |
Recruitment Status :
Active, not recruiting
First Posted : September 12, 2019
Last Update Posted : January 20, 2023
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Condition or disease | Intervention/treatment |
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Stress Urinary Incontinence | Device: AMS 800 Artificial Urinary Sphincter |
Study Type : | Observational |
Actual Enrollment : | 144 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Artificial Urinary Sphincter Clinical Outcomes |
Actual Study Start Date : | October 14, 2019 |
Estimated Primary Completion Date : | June 2024 |
Estimated Study Completion Date : | June 2024 |

Group/Cohort | Intervention/treatment |
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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.
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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. |
- 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
- Incidence of safety parameters [ Time Frame: 3 months, 6 months and 12 months ]Incidence of safety parameters at 3 months, 6 months, and 12 months. Safety parameters include device and/or procedure related adverse events, revision rates, and serious adverse events
- Number of subjects achieving ≥ 50% reduction in 24 hour pad weight test at 6 months [ Time Frame: Device Activation and 6 months ]Number of subjects achieving ≥ 50% reduction in urinary incontinence as measured by 24-hour pad weight test at device activation and 6 months post device activation compared to baseline
- Number of subjects achieving ≥ 75% reduction in 24 hour pad weight test at 6 and 12 months [ Time Frame: Device Activation, 6 months, and 12 months ]≥ 75% reduction in urinary incontinence as measured by 24-hour pad weight test at device activation, 6 months, and 12 months post device activation compared to baseline
- Number of pads per day [ Time Frame: 3 months, 6 months, and 12 months ]Reduction in # of pads per day at 3 months, 6 months and 12 months post-device activation compared to baseline

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088331

Principal Investigator: | Melissa Kaufman, MD | Vanderbilt Urology |
Responsible Party: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT04088331 |
Other Study ID Numbers: |
U0669 |
First Posted: | September 12, 2019 Key Record Dates |
Last Update Posted: | January 20, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Urinary Incontinence Urinary Incontinence, Stress Urination Disorders |
Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations |