INTIBIA Pivotal Study

NCT ID: NCT05250908

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-07
• Study Completion Date: 2026-06-27

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).

Detailed Description

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.

Conditions

Urinary Incontinence, Urge; Urinary Bladder, Overactive; Urinary Bladder Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

INTIBIA Therapeutic

Implanted with INTIBIA device and programmed to therapeutic stimulation for the duration of the study.

Group Type: EXPERIMENTAL

INTIBIA Therapeutic

Intervention Type: DEVICE

INTIBIA implantable tibial nerve stimulator with therapeutic stimulation

INTIBIA Non-Therapeutic

Implanted with INTIBIA device and programmed to non-therapeutic stimulation for the first 3 months, then to therapeutic stimulation for the duration of the study.

Group Type: EXPERIMENTAL

INTIBIA Non-Therapeutic

Intervention Type: DEVICE

INTIBIA implantable tibial nerve stimulator with non-therapeutic stimulation for 3 months, then therapeutic stimulation

Interventions

INTIBIA Therapeutic

INTIBIA implantable tibial nerve stimulator with therapeutic stimulation

Intervention Type: DEVICE

INTIBIA Non-Therapeutic

INTIBIA implantable tibial nerve stimulator with non-therapeutic stimulation for 3 months, then therapeutic stimulation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Matthews, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University

Locations

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

Countries

United States; Netherlands

Other Identifiers

IU024

Identifier Type: -

Identifier Source: org_study_id