INTIBIA Pivotal Study

A Prospective, Randomized Clinical Trial Evaluating INTIBIA, an Investigational Implantable Tibial Nerve Stimulator, Through 24-Months (INTIBIA Pivotal Study IU024)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Urologic Diseases; Urinary Bladder, Overactive; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence, Urge
• Intervention / Treatment: Device: INTIBIA Therapeutic; Device: INTIBIA Non-Therapeutic

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.

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1081 GG
    • Bergman Clinics, Women's Health, Department of Gynecology
  • Zwolle, Netherlands, 8025 AB
    • Isala Zwolle
• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Cedars-Sinai Medical Group
    • Los Angeles, California, United States, 90017
      • Urology Group of Southern California
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Florida
    • Daytona Beach, Florida, United States, 32114
      • Advanced Urology Associates
  • Georgia
    • Moultrie, Georgia, United States, 31768
      • Southeastern Urogynecology & Pelvic Surgery
  • Idaho
    • Idaho Falls, Idaho, United States, 83402
      • Rosemark WomenCare Specialists
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Cypress Medical Research Center, LLC
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Dearborn, Michigan, United States, 48124
      • Advanced Urogynecology of Michigan
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Specialty Clinical Research of St. Louis
  • New Jersey
    • Denville, New Jersey, United States, 07834
      • Atlantic Health System - AMG Urology (Garden State Urology)
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Wake Forest University
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • The Urology Group
    • Cleveland, Ohio, United States, 44109
      • MetroHealth System
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • The Institute for Female Pelvic Medicine and Reconstructive Surgery- Axia Womens Health
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • MidLantic Urology
    • Newtown, Pennsylvania, United States, 18940
      • The Female Pelvic Health Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Texas
    • Houston, Texas, United States, 77027
      • Houston Metro Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INTIBIA Therapeutic; Implanted with INTIBIA device and programmed to therapeutic stimulation for the duration of the study.	Device: INTIBIA Therapeutic; INTIBIA implantable tibial nerve stimulator with therapeutic stimulation
Experimental: 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.	Device: INTIBIA Non-Therapeutic; INTIBIA implantable tibial nerve stimulator with non-therapeutic stimulation for 3 months, then therapeutic stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urgency Score	Change in mean urgency score relative to baseline on a scale of 0 (no urgency) to 4 (urge incontinence)	3 Months
Daily Voids	Change in mean number of daily voids relative to baseline	3 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response Rate	≥50% reduction in UUUI episodes in the INTIBIA therapeutic group	6 Months
Response Rate	≥50% reduction in number of voids or a return to normal voiding frequency (< 8 voids/day)	3, 6, and 12 Months
Daily Voids	Change in mean number of daily voids relative to baseline	6 and 12 Months
Urgency Score	Change in mean urgency score relative to baseline on a scale of 0 (no urgency) to 4 (urge incontinence)	6 and 12 Months
International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form	Change in ICIQ-UI SF questionnaire total score compared to baseline. Scoring 0 (best outcome) - 21 (worst outcome)	3, 6, and 12 Months
OverActive Bladder questionnaire - Short Form	Change in the OABq-SF questionnaire total score compared to baseline. Scoring 1 (best) - 6 (worst) on 19 questions.	3, 6, and 12 Months
Dry	The proportion of dry subjects, defined as those with 0 incontinence episodes associated with urgency as captured on the 72-hour voiding diary	3, 6, and 12 Months
Patient's Global Impression of Improvement Questionnaire	The proportion of subjects reporting "much better" or "very much better" on the Patient Global Impression of Improvement (PGI-I) questionnaire	3, 6, and 12 Months
Surgical Satisfaction Questionnaire (SSQ-8)	Surgical Satisfaction Questionnaire (SSQ-8)	3 Months
EQ-5D-5L Questionnaire	Change in the EQ-5D-5L index score compared to baseline, on a 1-5 scale with 1 being the best outcome and 5 being the worst outcome. VAS scale measures overall health with 0 being the worst outcome and 100 being the best outcome.	3, 6, and 12 Months

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Catherine Matthews, MD, Wake Forest University

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): May 12, 2025
• Study Completion (Estimated): June 27, 2026

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: February 11, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 28, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urologic Diseases; Lower Urinary Tract Symptoms; Urinary Bladder, Overactive; Urinary Bladder Diseases; Urological Manifestations; Urinary Incontinence, Urge
• Other Study ID Numbers: IU024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No