• Diagnosis of overactive bladder with urgency urinary incontinence or mixed incontinence (urge and stress) with predominate urge, as confirmed by the MESA questionnaire;

• Women and men ≥ 18 years of age;

• Women of child-bearing age willing to practice birth control;

• At least 4 incontinent episodes associated with urgency on a 3-day voiding diary;

• At least 10 voids per day;

• Average urgency score of at least 2 as measured with IUSS on a 3-day voiding diary;

• Self-reported bladder symptoms present \> 6 months;

• Documented failure of an adequate trial of first and second line therapy;

• Off all antimuscarinics and beta-3 adrenergic agonists for at least 2 weeks prior to enrollment;

• If on Tricyclic antidepressants, dosage must be stabilized for at least 3 months;

• Have no active urethral obstruction/stricture, bladder calculi or bladder tumor based on medical history;

• Normal upper urinary tract function based on medical history;

• Based on the medical opinion of the Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject;

• Based on the medical opinion of the Investigator, subject is willing and able to operate the patient programmer, recharging equipment, diary and has the ability to undergo study assessments and provide accurate responses;

• Based on the medical opinion of the Investigator, subject is a good surgical subject for the implant procedure;

• Capable of giving informed consent;

• Capable and willing to follow all study related procedures.