AzTrials
AzTrials

Urinary Incontinence, UrgeNCT05250908

INTIBIA Pivotal Study

A study testing INTIBIA Therapeutic and INTIBIA Non-Therapeutic in people with Urinary Incontinence, Urge and Urinary Bladder, Overactive, run by Coloplast A/S at 22 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 22 to 80 years
What is being tested?
INTIBIA Therapeutic and INTIBIA Non-Therapeutic
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
22 sitesin 2 countries
Study dates
7 Mar 2022to Jun 2029
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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])
Show all 25Show fewer
  • 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

Trial locations and contacts

22 sites in 2 countries.

22 sites in 2 countries

United States20 sites

  • The Institute for Female Pelvic Medicine and Reconstructive Surgery- Axia Womens Health

    Allentown, Pennsylvania, 18103

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

  • Cedars-Sinai Medical Group

    Beverly Hills, California, 90211

  • The Urology Group

    Cincinnati, Ohio, 45212

  • MetroHealth System

    Cleveland, Ohio, 44109

  • Advanced Urology Associates

    Daytona Beach, Florida, 32114

  • Advanced Urogynecology of Michigan

    Dearborn, Michigan, 48124

  • Atlantic Health System - AMG Urology (Garden State Urology)

    Denville, New Jersey, 07834

  • Houston Metro Urology

    Houston, Texas, 77027

  • Rosemark WomenCare Specialists

    Idaho Falls, Idaho, 83402

  • Urology Group of Southern California

    Los Angeles, California, 90017

  • Southeastern Urogynecology & Pelvic Surgery

    Moultrie, Georgia, 31768

  • The Female Pelvic Health Center

    Newtown, Pennsylvania, 18940

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Specialty Clinical Research of St. Louis

    St Louis, Missouri, 63141

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Cypress Medical Research Center, LLC

    Wichita, Kansas, 67226

  • Wake Forest University

    Winston-Salem, North Carolina, 27103

Other trials in United States

Netherlands2 sites

  • Bergman Clinics, Women's Health, Department of Gynecology

    Amsterdam, 1081 GG

  • Isala Zwolle

    Zwolle, 8025 AB

Other trials in Netherlands

About this study

Official title: A Prospective, Randomized Clinical Trial Evaluating INTIBIA, an Investigational Implantable Tibial Nerve Stimulator (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).

Read the 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, 24, 36, 48, and 60. Subjects will be offered to keep the device or have it explanted at the end of the study.

Being tested
INTIBIA Therapeutic, INTIBIA Non-Therapeutic
Medical subject headings
Urinary Incontinence, Urge, Urinary Bladder, Overactive, Urinary Bladder Diseases, Urologic Diseases, Lower Urinary Tract Symptoms, Urological Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INTIBIA TherapeuticDevice

    INTIBIA implantable tibial nerve stimulator with therapeutic stimulation

  • INTIBIA Non-TherapeuticDevice

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

Study groups in NCT05250908
Study groupRoleWhat they receive
INTIBIA TherapeuticExperimentalImplanted with INTIBIA device and programmed to therapeutic stimulation for the duration of the study.
Receives: Device: INTIBIA Therapeutic
INTIBIA Non-TherapeuticExperimentalImplanted with INTIBIA device and programmed to non-therapeutic stimulation for the first 3 months, then to therapeutic stimulation for the duration of the study.
Receives: Device: INTIBIA Non-Therapeutic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Rate

    ≥50% reduction in UUI episodes between INTIBIA therapeutic and INTIBIA non-therapeutic

    Measured: 3 Months

  2. Response Rate

    ≥50% reduction in UUUI episodes in the INTIBIA therapeutic group

    Measured: 12 Months

Secondary outcomes (2)

  1. Urgency Score

    Change in mean urgency score relative to baseline on a scale of 0 (no urgency) to 4 (urge incontinence)

    Measured: 3 Months

  2. Daily Voids

    Change in mean number of daily voids relative to baseline

    Measured: 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2022
  2. Study start7 Mar 2022
  3. Primary completion12 May 2025
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model 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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05250908
Sponsor's protocol ID
IU024
Status last verified
Oct 2026
First submitted
11 Feb 2022
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in