INTIBIA Pivotal Study

All eligible subjects will be implanted with the INTIBIA device. Subjects will be randomized to either INTIBIA therapeutic or INTIBIA non-therapeutic in a 2:1 ratio for the first 3 months of the study, at which point all subjects will receive therapeutic stimulation. Subjects will complete voiding diaries and questionnaires at Baseline and prior to each follow-up visit, which will occur at Months 3, 6, 12, and 24. Subjects will be offered to keep the device or have it explanted at the end of the 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 limiting placement of device per physician discretion
• Evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject
• Prior treatment of urinary symptoms with nerve stimulation (e.g., percutaneous tibial 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 or OFF
• Treatment of urinary symptoms with botulinum toxin therapy within six (6) months
• Any neurological condition that could interfere with normal bladder or tibial nerve function, including debilitating stroke, epilepsy, multiple sclerosis, Parkinson's disease, peripheral neuropathy, fibromyalgia, or spinal cord injury (e.g., paraplegia)
• Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral 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 the past two years
• Pelvic organ prolapse at or beyond the hymenal ring
• Interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines prior to INTIBIA implant date
• Diabetes with peripheral nerve compromise or uncontrolled diabetes
• Pregnant as confirmed by urine or serum pregnancy test, plans to become pregnant over 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, or polyurethane
• Allergy to local anesthetic or adhesives
• Deemed unsuitable for enrollment by the investigator based on history or physical examination (e.g., bleeding disorders, current anticoagulant medications)
• Enrolled in another investigational or interventional device or drug trial over the study period