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

Key Inclusion Criteria

• Age 18 years and above.
• Diagnosed with urinary urge incontinence.
• Have no reported history of urethral obstruction/stricture, bladder calculi or bladder tumor.
• Have normal upper urinary tract function.
• Be capable of giving informed consent.
• Be capable and willing to follow all study related procedures.

Key Exclusion Criteria

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