INTIBIA Pivotal Study
A Prospective, Randomized Clinical Trial Evaluating INTIBIA, an Investigational Implantable Tibial Nerve Stimulator, Through 24-Months (INTIBIA Pivotal Study IU024)
1 other identifier
interventional
208
2 countries
22
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
Longer than P75 for not_applicable
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2022
CompletedFirst Posted
Study publicly available on registry
February 22, 2022
CompletedStudy Start
First participant enrolled
March 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2026
ExpectedMarch 2, 2026
February 1, 2026
3.2 years
February 11, 2022
February 28, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Response Rate
≥50% reduction in UUI episodes between INTIBIA therapeutic and INTIBIA non-therapeutic
3 Months
Response Rate
≥50% reduction in UUUI episodes in the INTIBIA therapeutic group
12 Months
Secondary Outcomes (2)
Urgency Score
3 Months
Daily Voids
3 Months
Other Outcomes (10)
Response Rate
6 Months
Response Rate
3, 6, and 12 Months
Daily Voids
6 and 12 Months
- +7 more other outcomes
Study Arms (2)
INTIBIA Therapeutic
EXPERIMENTALImplanted with INTIBIA device and programmed to therapeutic stimulation for the duration of the study.
INTIBIA Non-Therapeutic
EXPERIMENTALImplanted with INTIBIA device and programmed to non-therapeutic stimulation for the first 3 months, then to therapeutic stimulation for the duration of the study.
Interventions
INTIBIA implantable tibial nerve stimulator with therapeutic stimulation
INTIBIA implantable tibial nerve stimulator with non-therapeutic stimulation for 3 months, then therapeutic stimulation
Eligibility Criteria
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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coloplast A/Slead
Study Sites (22)
Cedars-Sinai Medical Group
Beverly Hills, California, 90211, United States
Urology Group of Southern California
Los Angeles, California, 90017, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Advanced Urology Associates
Daytona Beach, Florida, 32114, United States
Southeastern Urogynecology & Pelvic Surgery
Moultrie, Georgia, 31768, United States
Rosemark WomenCare Specialists
Idaho Falls, Idaho, 83402, United States
Cypress Medical Research Center, LLC
Wichita, Kansas, 67226, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Advanced Urogynecology of Michigan
Dearborn, Michigan, 48124, United States
Specialty Clinical Research of St. Louis
St Louis, Missouri, 63141, United States
Atlantic Health System - AMG Urology (Garden State Urology)
Denville, New Jersey, 07834, United States
Wake Forest University
Winston-Salem, North Carolina, 27103, United States
The Urology Group
Cincinnati, Ohio, 45212, United States
MetroHealth System
Cleveland, Ohio, 44109, United States
The Institute for Female Pelvic Medicine and Reconstructive Surgery- Axia Womens Health
Allentown, Pennsylvania, 18103, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
The Female Pelvic Health Center
Newtown, Pennsylvania, 18940, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Houston Metro Urology
Houston, Texas, 77027, United States
Bergman Clinics, Women's Health, Department of Gynecology
Amsterdam, 1081 GG, Netherlands
Isala Zwolle
Zwolle, 8025 AB, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine Matthews, MD
Wake Forest University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Subjects and investigator/site personnel are blinded until the Month 3 visit.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2022
First Posted
February 22, 2022
Study Start
March 7, 2022
Primary Completion
May 12, 2025
Study Completion (Estimated)
June 27, 2026
Last Updated
March 2, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share