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)