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Artificial Urinary Sphincter Clinical Outcomes

Recruiting

The study objective is to evaluate the AMS 800 Artificial Urinary Sphincter™ (AUS) in men with primary stress urinary incontinence as measured by pad weight tests. The AMS 800 Artificial Urinary Sphincter is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. Treatment success defined as ≥ 50% reduction in 24-hour pad weight test from baseline at 12 months post device activation.

I'm interested

Male
18 Years and over
This study is NOT accepting healthy volunteers
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)

Device: AMS 800 Artificial Urinary Sphincter

Stress Urinary Incontinence

Clinics and Surgery Center (CSC)

Maressa Twedt - twedt050@umn.edu
Sean Elliott
NA
STUDY00008574
NCT04088331
See this study on ClinicalTrials.gov

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