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.