INTIBIA Pivotal Study

Running, not enrolling · Not applicable

Conditions studied: Urinary Incontinence, Urge, Urinary Bladder, Overactive, Urinary Bladder Diseases, Urologic Diseases, Lower Urinary Tract Symptoms, Urological Manifestations

In brief

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).

Key facts

Study ID: NCT05250908
Run by: Coloplast A/S
People needed: 208
Starts: 2022-03-07
Expected to finish: 2026-06-27
Last updated by the study team: 2026-03-02

Who can join

Age: 22 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Cedars-Sinai Medical Group — Beverly Hills, California, United States
Urology Group of Southern California — Los Angeles, California, United States
MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
Advanced Urology Associates — Daytona Beach, Florida, United States
Southeastern Urogynecology & Pelvic Surgery — Moultrie, Georgia, United States
Rosemark WomenCare Specialists — Idaho Falls, Idaho, United States
Cypress Medical Research Center, LLC — Wichita, Kansas, United States
Baystate Medical Center — Springfield, Massachusetts, United States
University of Michigan — Ann Arbor, Michigan, United States
Advanced Urogynecology of Michigan — Dearborn, Michigan, United States
Specialty Clinical Research of St. Louis — St Louis, Missouri, United States
Atlantic Health System - AMG Urology (Garden State Urology) — Denville, New Jersey, United States
Wake Forest University — Winston-Salem, North Carolina, United States
The Urology Group — Cincinnati, Ohio, United States
MetroHealth System — Cleveland, Ohio, United States
The Institute for Female Pelvic Medicine and Reconstructive Surgery- Axia Womens Health — Allentown, Pennsylvania, United States
MidLantic Urology — Bala-Cynwyd, Pennsylvania, United States
The Female Pelvic Health Center — Newtown, Pennsylvania, United States
Thomas Jefferson University — Philadelphia, Pennsylvania, United States
Houston Metro Urology — Houston, Texas, United States
Bergman Clinics, Women's Health, Department of Gynecology — Amsterdam, Netherlands
Isala Zwolle — Zwolle, Netherlands

Full record on ClinicalTrials.gov

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