INTIBIA Pivotal Study

About

Brief Summary

Prospective, randomized, double-blind, multicenter study to evaluate the safety and efficacy of an implantable tibial nerve stimulator in subjects with urgency urinary incontinence (UUI).

Primary Purpose

Treatment

Study Type

Interventional

Phase

N/A

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

22 Years

Maximum Age

80 Years

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 or any evidence of an infection, edema or inflammation in either lower leg
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 twelve (12) months
Any neurological condition that could interfere with normal bladder or tibial nerve function, including 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 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

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