INTIBIA Pivotal Study

February 5, 2024 updated by: Coloplast A/S

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

225

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1081 GG
      • Zwolle, Netherlands, 8025 AB
        • Recruiting
        • Isala Zwolle
        • Contact:
        • Principal Investigator:
          • H.W.F. van Eijndhoven, Dr.
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Cedars-Sinai Medical Group
        • Contact:
        • Principal Investigator:
          • Karyn Eilber, MD
      • Los Angeles, California, United States, 90017
        • Recruiting
        • Urology Group of Southern California
        • Contact:
        • Principal Investigator:
          • John Kowalczyk, DO
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • MedStar Washington Hospital Center
        • Contact:
        • Principal Investigator:
          • Alexis Dieter, MD
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Recruiting
        • Advanced Urology Associates
        • Contact:
        • Principal Investigator:
          • Samuel Lawindy, MD
    • Georgia
      • Moultrie, Georgia, United States, 31768
        • Recruiting
        • Southeastern Urogynecology & Pelvic Surgery
        • Principal Investigator:
          • Cheau Williams, MD
        • Contact:
    • Idaho
      • Idaho Falls, Idaho, United States, 83402
        • Recruiting
        • Rosemark WomenCare Specialists
        • Contact:
        • Principal Investigator:
          • Ty Erickson, MD
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Recruiting
        • Cypress Medical Research Center, LLC
        • Contact:
        • Principal Investigator:
          • Kevin Miller, MD
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02138
        • Recruiting
        • Boston Urogynecology Associates, Inc
        • Principal Investigator:
          • Peter Rosenblatt, MD
        • Contact:
          • Kathleen Rogers
          • Phone Number: 617-354-5452
      • Springfield, Massachusetts, United States, 01199
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Principal Investigator:
          • John Stoffel, MD
        • Contact:
      • Dearborn, Michigan, United States, 48124
        • Active, not recruiting
        • Advanced Urogynecology of Michigan
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Specialty Clinical Research of St. Louis
        • Principal Investigator:
          • Travis Bullock, MD
        • Contact:
    • New Jersey
      • Denville, New Jersey, United States, 07834
        • Recruiting
        • Atlantic Health System - AMG Urology (Garden State Urology)
        • Contact:
        • Principal Investigator:
          • Michael Ingber, MD
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Wake Forest University
        • Contact:
        • Principal Investigator:
          • Catherine Matthews, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Recruiting
        • The Urology Group
        • Principal Investigator:
          • Marc Pliskin, DO
        • Contact:
      • Cleveland, Ohio, United States, 44109
        • Recruiting
        • MetroHealth System
        • Contact:
        • Principal Investigator:
          • Jeffrey Mangel, MD
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • The Institute for Female Pelvic Medicine and Reconstructive Surgery- Axia Womens Health
        • Contact:
        • Principal Investigator:
          • Vincent Lucente, MD
      • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Newtown, Pennsylvania, United States, 18940
        • Recruiting
        • The Female Pelvic Health Center
        • Contact:
        • Principal Investigator:
          • Stephanie Molden, MD
      • Philadelphia, Pennsylvania, United States, 19107
    • Texas
      • Houston, Texas, United States, 77027
        • Recruiting
        • Houston Metro Urology
        • Contact:
        • Principal Investigator:
          • Lawrence Baum, MD
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 3 Months
≥50% reduction in UUI episodes between INTIBIA therapeutic and INTIBIA non-therapeutic
3 Months
Response Rate
Time Frame: 12 Months
≥50% reduction in UUUI episodes in the INTIBIA therapeutic group
12 Months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate
Time Frame: 6 Months
≥50% reduction in UUUI episodes in the INTIBIA therapeutic group
6 Months
Response Rate
Time Frame: 3, 6, and 12 Months
≥50% reduction in number of voids or a return to normal voiding frequency (< 8 voids/day)
3, 6, and 12 Months
Daily Voids
Time Frame: 6 and 12 Months
Change in mean number of daily voids relative to baseline
6 and 12 Months
Urgency Score
Time Frame: 6 and 12 Months
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
Time Frame: 3, 6, and 12 Months
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
Time Frame: 3, 6, and 12 Months
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
Time Frame: 3, 6, and 12 Months
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
Time Frame: 3, 6, and 12 Months
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)
Time Frame: 3 Months
Surgical Satisfaction Questionnaire (SSQ-8)
3 Months
EQ-5D-5L Questionnaire
Time Frame: 3, 6, and 12 Months
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

This is where you will find people and organizations involved with this study.

Sponsor

Coloplast A/S

Investigators

  • Principal Investigator: Catherine Matthews, MD, Wake Forest University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2022

Primary Completion (Estimated)

March 7, 2024

Study Completion (Estimated)

March 7, 2025

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 (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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