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.
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
- Conditions the study is for
- Urinary Incontinence, Urge, Urinary Bladder, Overactive, Urinary Bladder Diseases
- 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
- Are there results?
- Not yet: the study is under way
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
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- 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])
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- 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
Netherlands2 sites
Bergman Clinics, Women's Health, Department of Gynecology
Amsterdam, 1081 GG
Isala Zwolle
Zwolle, 8025 AB
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.
- Conditions
- Urinary Incontinence, Urge, Urinary Bladder, Overactive, Urinary Bladder Diseases, Urologic Diseases, Lower Urinary Tract Symptoms, Urological Manifestations
- 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 group | Role | What they receive |
|---|---|---|
| INTIBIA Therapeutic | Experimental | Implanted with INTIBIA device and programmed to therapeutic stimulation for the duration of the study. Receives: Device: INTIBIA Therapeutic |
| INTIBIA Non-Therapeutic | Experimental | 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. Receives: Device: INTIBIA Non-Therapeutic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
≥50% reduction in UUI episodes between INTIBIA therapeutic and INTIBIA non-therapeutic
Measured: 3 Months
Response Rate
≥50% reduction in UUUI episodes in the INTIBIA therapeutic group
Measured: 12 Months
Secondary outcomes (2)
Urgency Score
Change in mean urgency score relative to baseline on a scale of 0 (no urgency) to 4 (urge incontinence)
Measured: 3 Months
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.
- First posted22 Feb 2022
- Study start7 Mar 2022
- Primary completion12 May 2025
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, UrgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Catherine Matthews, MD, Principal investigator, Wake Forest University
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Clinical Trial Evaluating INTIBIA, an Investigational Implantable Tibial Nerve Stimulator (INTIBIA Pivotal Study IU024)
- ClinicalTrials.gov ID
- NCT05250908
- Acronym / sponsor ID
- IU024
- Conditions
- Urinary Incontinence, Urge, Urinary Bladder, Overactive, Urinary Bladder Diseases, Urologic Diseases, Lower Urinary Tract Symptoms, Urological Manifestations
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- Jun 2029 (estimated)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 24, 36, 48, and 60. Subjects will be offered to keep the device or have it explanted at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| INTIBIA Therapeutic | Experimental | Device: INTIBIA TherapeuticImplanted with INTIBIA device and programmed to therapeutic stimulation for the duration of the study. |
| INTIBIA Non-Therapeutic | Experimental | Device: INTIBIA Non-TherapeuticImplanted with INTIBIA device and programmed to non-therapeutic stimulation for the first 3 months, then to therapeutic stimulation for the duration of the study. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INTIBIA TherapeuticINTIBIA implantable tibial nerve stimulator with therapeutic stimulation | Device | INTIBIA Therapeutic |
| INTIBIA Non-TherapeuticINTIBIA implantable tibial nerve stimulator with non-therapeutic stimulation for 3 months, then therapeutic stimulation | Device | INTIBIA Non-Therapeutic |
Primary outcome
Response Rate
Time frame: 3 Months
≥50% reduction in UUI episodes between INTIBIA therapeutic and INTIBIA non-therapeutic
Response Rate
Time frame: 12 Months
≥50% reduction in UUUI episodes in the INTIBIA therapeutic group
2 secondary outcomes
Urgency Score
Time frame: 3 Months
Daily Voids
Time frame: 3 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Matthews, MD principal investigator
Wake Forest University
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: 3 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.