Artificial Urinary Sphincter Clinical Outcomes

Exclusion Criteria

• •1. Previously had or currently has a device implanted (AUS/Sling, or otherwise) for treatment of SUI or urge incontinence
• •2. Primary urgency incontinence
• •3. Postvoid residual volume greater that 150 ml or a history of difficulty emptying the bladder
• •4. Recurrent vesicourethral anastomotic stricture or urethral stricture disease within the past 6 months
• •5. Known urogenital malignancy other than previously treated prostate cancer
• •6. Recurrent prostate cancer that is expected to require intervention during the study follow-up period
• •7. History of recurrent bladder stones within the past 12 months prior to signing the informed consent
• •8. Neurogenic bladder
• •9. Need for intermittent catheterization
• •10. Known history of bleeding diathesis or coagulopathy
• •11. Immunosuppressed or on medical therapy which would impact the immune system
• •12. Uncontrolled diabetes, defined as (HbA1c\>10)
• •13. Has a genitourinary mechanical prosthesis that was implanted within 3 months from the date of consent
• •14. Had a post-implantation infection associated with the device after genitourinary mechanical prosthesis was implanted
• •15. Undergone bulking procedure within 6 months of the baseline assessment
• •16. Poor candidate for surgical procedures and/or anesthesia due to physical or mental conditions
• •17. Urinary incontinence due to or complicated by an irreversibly obstructed lower urinary tract
• •18. Irresolvable detrusor hyperreflexia or bladder instability
• •19. Currently enrolled or plans to enroll in another device or drug clinical trial
• •20. 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
• •21. Known allergy or sensitivity to rifampin or to minocycline HCl or other tetracyclines (only applicable when implanting with InhibiZone version of this device)
• •22. Systemic lupus erythematosus because minocycline HCl has been reported to aggravate this condition (only applicable when implanting with InhibiZone version of this device)