An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence

Exclusion Criteria

• •1. Have any active implantable device regardless of whether stimulation status is ON or OFF.
• •2. Are pregnant as confirmed by a urine pregnancy test or plan to become pregnant during the following 12 months period.
• •3. Less than one year post partum and/or are breast-feeding.
• •4. Have any passive implant that contains metal or electrically conductive materials.
• •5. Have conditions requiring Magnetic Resonance Imaging (MRI) evaluation.
• •6. Have conditions requiring diathermy procedures.
• •7. Have an inability to operate the bion Remote Control and bion Recharging System either by self or caregiver.
• •8. Have diabetes with peripheral nerve involvement or have severe uncontrolled diabetes.
• •9. Have history of coagulopathy or bleeding disorder.
• •10. Have a history of pelvic pain as primary diagnosis.
• •11. Have anatomical restrictions such that the study device placement is not possible.
• •12. Are currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function.
• •13. Have a life expectancy of less than 1 year.
• •14. Cannot independently comprehend and complete the QoL questionnaires.