INTIBIA Pivotal Study

Inclusion Criteria:

• Women or men 22-80 years of age

• Symptoms of overactive bladder with urgency urinary incontinence (UUI) demonstratedon a 72-hour voiding diary defined as a minimum of four (4) leaking episodesassociated 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, fluidmanagement)

• Willing to abstain from OAB medications for the duration of the study

• Willing to maintain a stable dose of all other medications that affect bladderfunction (e.g., tricyclic antidepressants) for at least four (4) weeks prior tobeginning 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 theprotocol

Exclusion Criteria:

• Diagnosis of stress urinary incontinence or mixed urinary incontinence, as confirmedby 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 limitingplacement of device per physician discretion

• Evidence of anatomic abnormalities that could jeopardize the placement of the deviceor pose a hazard to the subject

• Prior treatment of urinary symptoms with nerve stimulation (e.g., percutaneoustibial nerve stimulation [PTNS] or sacral nerve stimulation [SNS])

• History of chronic pain (e.g., chronic pelvic pain, fibromyalgia, Lyme disease,chronic back pain)

• An active implantable electronic device regardless of whether stimulation is ON orOFF

• Treatment of urinary symptoms with botulinum toxin therapy within six (6) months

• Any neurological condition that could interfere with normal bladder or tibial nervefunction, including debilitating stroke, epilepsy, multiple sclerosis, Parkinson'sdisease, peripheral neuropathy, fibromyalgia, or spinal cord injury (e.g.,paraplegia)

• Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement orurethral stricture)

• Other urinary tract dysfunction (e.g., abnormal upper urinary tract function,vesicoureteral reflux, bladder stone or tumor, urinary fistula)

• End stage renal failure, GFR < 35, or dialysis

• History of pelvic cancer requiring radiation or chemotherapy treatment within thepast two years

• Pelvic organ prolapse at or beyond the hymenal ring

• Interstitial cystitis or bladder pain syndrome as defined by either AmericanUrological Association (AUA) or European Association of Urology (EAU) guidelinesprior to INTIBIA implant date

• Diabetes with peripheral nerve compromise or uncontrolled diabetes

• Pregnant as confirmed by urine or serum pregnancy test, plans to become pregnantover the study period, is less than one-year post-partum, is breast-feeding

• Current active or a chronic systemic infection

• Condition requiring magnetic resonance imaging (MRI) of lower leg

• Condition requiring diathermy

• Allergy to polyethylene terephthalate, silicone rubber, platinum, iridium, orpolyurethane

• Allergy to local anesthetic or adhesives

• Deemed unsuitable for enrollment by the investigator based on history or physicalexamination (e.g., bleeding disorders, current anticoagulant medications)

• Enrolled in another investigational or interventional device or drug trial over thestudy period