Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Implantable nerve stimulator shows promise for bladder control

NCT ID NCT05250908

Disease control Sponsor: Coloplast A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a small implant called INTIBIA that stimulates a nerve in the leg to help control sudden, strong urges to urinate. About 208 adults with overactive bladder and frequent leaking episodes will receive the implant. The goal is to see if it safely reduces leaking by at least half compared to a non-working device.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

208 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Lower urinary tract symptoms are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Lower Urinary Tract Symptoms overactive bladder urinary bladder disorder Urinary Incontinence, Urge urinary system disorder Urological Manifestations

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lower urinary tract symptoms Urinary bladder diseases Urinary bladder, overactive Urinary incontinence, urge Urologic diseases Urological manifestations

Contacts and locations

Locations

  • Advanced Urogynecology of Michigan

    Dearborn, Michigan, 48124, United States

  • Advanced Urology Associates

    Daytona Beach, Florida, 32114, United States

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

    Denville, New Jersey, 07834, United States

  • Baystate Medical Center

    Springfield, Massachusetts, 01199, United States

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

    Amsterdam, 1081 GG, Netherlands

  • Cedars-Sinai Medical Group

    Beverly Hills, California, 90211, United States

  • Cypress Medical Research Center, LLC

    Wichita, Kansas, 67226, United States

  • Houston Metro Urology

    Houston, Texas, 77027, United States

  • Isala Zwolle

    Zwolle, 8025 AB, Netherlands

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • MetroHealth System

    Cleveland, Ohio, 44109, United States

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Rosemark WomenCare Specialists

    Idaho Falls, Idaho, 83402, United States

  • Southeastern Urogynecology & Pelvic Surgery

    Moultrie, Georgia, 31768, United States

  • Specialty Clinical Research of St. Louis

    St Louis, Missouri, 63141, United States

  • The Female Pelvic Health Center

    Newtown, Pennsylvania, 18940, United States

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

    Allentown, Pennsylvania, 18103, United States

  • The Urology Group

    Cincinnati, Ohio, 45212, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • Urology Group of Southern California

    Los Angeles, California, 90017, United States

  • Wake Forest University

    Winston-Salem, North Carolina, 27103, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.