AUSCO: Artificial Urinary Sphincter Clinical Outcomes
Study Details
Study Description
Brief Summary
To evaluate the AMS 800 Artificial Urinary Sphincter (AUS) in men with primary stress urinary incontinence as measured by pad weight tests.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
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Outcome Measures
Primary Outcome Measures
- Number of subjects with reduction in 24 hour pad weight test at 12 months [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 Outcome Measures
- Incidence of safety parameters [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 [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 [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 [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male
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≥ 18 years of age
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Has undergone either a radical prostatectomy, transurethral resection of the prostate or other invasive prostate surgery
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Demonstrates primary stress urinary incontinence
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Positive screening 24-hour pad weight test (≥100 grams)
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Experiences at least 3 incontinence episodes per day during baseline diary or presents with continuous incontinence
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Negative urine culture
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Willing and able to undergo surgical implantation of the AUS device
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Willing and able to comply with the follow-up requirements
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Willing and able to forego any other surgical urinary incontinence treatments while participating in the study
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Willing and able to sign the informed consent
Exclusion Criteria:
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Previously had or currently has a device implanted (AUS/Sling, or otherwise) for treatment of SUI or urge incontinence
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Primary urgency incontinence
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Postvoid residual volume greater that 150 ml or a history of difficulty emptying the bladder
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Recurrent vesicourethral anastomotic stricture or urethral stricture disease within the past 6 months
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Known urogenital malignancy other than previously treated prostate cancer
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Recurrent prostate cancer that is expected to require intervention during the study follow-up period
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History of recurrent bladder stones within the past 12 months prior to signing the informed consent
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Neurogenic bladder
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Need for intermittent catheterization
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Known history of bleeding diathesis or coagulopathy
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Immunosuppressed or on medical therapy which would impact the immune system
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Uncontrolled diabetes, defined as (HbA1c>10)
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Has a genitourinary mechanical prosthesis that was implanted within 3 months from the date of consent
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Had a post-implantation infection associated with the device after genitourinary mechanical prosthesis was implanted
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Undergone bulking procedure within 6 months of the baseline assessment
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Poor candidate for surgical procedures and/or anesthesia due to physical or mental conditions
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Urinary incontinence due to or complicated by an irreversibly obstructed lower urinary tract
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Irresolvable detrusor hyperreflexia or bladder instability
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Currently enrolled or plans to enroll in another device or drug clinical trial
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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
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Known allergy or sensitivity to rifampin or to minocycline HCl or other tetracyclines (only applicable when implanting with InhibiZone version of this device)
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Systemic lupus erythematosus because minocycline HCl has been reported to aggravate this condition (only applicable when implanting with InhibiZone version of this device)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, San Francisco | San Francisco | California | United States | 94110 |
| 2 | University of Colorado Hospital | Aurora | Colorado | United States | 80045 |
| 3 | University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States | 52242 |
| 4 | University of Kansas Hospital | Kansas City | Kansas | United States | 66160-7234 |
| 5 | Willis-Knighton Bossier Medical Center | Bossier City | Louisiana | United States | 71111 |
| 6 | Johns Hopkins Hospital | Baltimore | Maryland | United States | 21287 |
| 7 | Lahey Clinic Hospital | Burlington | Massachusetts | United States | 01805 |
| 8 | University of Minnesota Medical Center | Minneapolis | Minnesota | United States | 55455 |
| 9 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 10 | Wake Forest University School of Medicine | Winston-Salem | North Carolina | United States | 27103 |
| 11 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 12 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
| 13 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 14 | The Methodist Hospital Research Institute | Houston | Texas | United States | 77030 |
| 15 | Urology San Antonio Research, PA. | San Antonio | Texas | United States | 78229 |
| 16 | University of Utah | Salt Lake City | Utah | United States | 84132 |
| 17 | Concord Repatriation General Hospital | Concord | New South Wales | Australia | 2139 |
| 18 | Australian Urology Associates | Melbourne | Victoria | Australia | 3144 |
Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
- Principal Investigator: Melissa Kaufman, MD, Vanderbilt Urology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- U0669