An Implantable Microstimulator for the Chronic Treatment of Urinary Urgency-Frequency Syndrome

Key Inclusion criteria: Age 18 years and above. Diagnosed with urinary urgency-frequency syndrome. 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 month period. Less than one year post partum and/or are breast-feeding. Have any large passive implant that contains metal located within 30 cm of the chair pad while seated (e.g., hip replacement). 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 pelvic pain in the absence of voiding dysfunction. 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. Cannot independently comprehend and complete the questionnaires.