Artificial Urinary Sphincter Clinical Outcomes

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

Official Title
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Artificial Urinary Sphincter Clinical Outcomes

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: AMS 800 Artificial Urinary Sphincter


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AMS 800 Artificial Urinary Sphincter Recipients<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of safety parameters | 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 | 3 months, 6 months and 12 months | 
| Number of subjects achieving ≥ 50% reduction in 24 hour pad weight test at 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 | Device Activation and 6 months | 
| Number of subjects achieving ≥ 75% reduction in 24 hour pad weight test at 6 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 | Device Activation, 6 months, and 12 months | 
| Number of pads per day | Reduction in # of pads per day at 3 months, 6 months and 12 months post-device activation compared to baseline | 3 months, 6 months, and 12 months |