INTIBIA Pivotal Study

Inclusion Criteria: * Women or men 22-80 years of age * Symptoms of overactive bladder with urgency urinary incontinence (UUI) demonstrated on a 72-hour voiding diary defined as a minimum of four (4) leaking episodes associated with urgency, and at least one leaking episode each 24-hour period * Greater than or equal to 6-month history of UUI diagnosis * Failure of conservative or behavioral therapy (e.g., bladder diet, timed voiding, bladder training, bladder control strategies, pelvic floor muscle training, fluid management) * Willing to abstain from OAB medications for the duration of the study * Willing to maintain a stable dose of all other medications that affect bladder function (e.g., tricyclic antidepressants) for at least four (4) weeks prior to beginning the baseline voiding diary and baseline questionnaires * Ambulatory and able to use the toilet independently and without difficulty * Willing and capable of providing informed consent * Willing and able to complete all procedures and follow-up visits indicated in the protocol Exclusion Criteria: * Diagnosis of stress urinary incontinence or mixed urinary incontinence, as confirmed by cough stress test and with a response of Yes to Q3 on the UDI-6 questionnaire * Current symptomatic urinary tract infection (UTI), urethritis, or more than three (3) UTIs in past year * Have post-void residual urine volume \>30% of total voided volume * Inadequate skin integrity, any evidence of an infection, or lower leg edema limi…