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New implant zaps nerves to stop bladder leaks

NCT ID NCT05226286

Disease control Sponsor: MedtronicNeuro 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a small implantable device that stimulates the tibial nerve to treat overactive bladder. 188 adults with urge incontinence who had not improved with other treatments received the implant. The main goal was to see if at least half of participants had a 50% or greater reduction in daily leakage episodes after 6 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Medtronic Implantable Tibial Neuromodulation (TNM) System
What this could lead to
If successful, this device could offer a long-term, implantable option for people with overactive bladder who haven't improved with other treatments.
What could go wrong
This is a completed pivotal study, but results may not apply to everyone. Risks include surgical implantation, device malfunction, or lack of symptom relief.

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

188 people

The number who actually took part.

Started

Jan 2022

Finished

May 2025

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

18 years and older

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: 1. Subjects 18 years of age or older 2. Qualifying voiding diary 3. Have a diagnosis of UUI for at least 6 months 4. Failed and/or are not a candidate for conservative therapies. 5. Willing and able to accurately complete study diaries, questionnaires, attend visits, operate the system, and comply with the study protocol 6. Willing and able to provide signed and dated informed consent Exclusion Criteria: 1. Have primary stress incontinence 2. History of a prior implantable tibial neuromodulation system 3. Anatomical defects, clinically significant edema or previous surgeries which precludes use of the device 4. Previous pelvic floor surgery in the last 6 months 5. Women who are pregnant or planning to become pregnant during the course of the study 6. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements. 7. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.

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Conditions

The condition(s) this trial relates to.

overactive bladder

As listed by the trial registrant

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

Overactive bladder

Contacts and locations

Locations

  • Alliance Urology Specialists

    Greensboro, North Carolina, 27403, United States

  • Ascension Columbia St. Mary's

    Milwaukee, Wisconsin, 53211, United States

  • Associated Medical Professionals

    Syracuse, New York, 13210, United States

  • Atrium Health Carolinas Medical Center

    Charlotte, North Carolina, 28203, United States

  • Central Ohio Urology Group

    Gahanna, Ohio, 43230, United States

  • Chesapeake Urology Associates

    Towson, Maryland, 21204, United States

  • FirstHealth Urogynecology

    Hamlet, North Carolina, 28345, United States

  • Georgia Urology

    Cartersville, Georgia, 30120, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Louisiana State University Health Sciences Center

    New Orleans, Louisiana, 70006, United States

  • Mayo Clinic Urology

    Rochester, Minnesota, 55905, United States

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503, United States

  • Michigan Institute of Urology

    Troy, Michigan, 48084, United States

  • Minnesota Urology

    Plymouth, Minnesota, 55441, United States

  • Northwestern Medicine

    Chicago, Illinois, 60611, United States

  • Prisma Health

    Greenville, South Carolina, 29605, United States

  • Providea Health Partners

    Evergreen Park, Illinois, 60805, United States

  • Sanford Female Pelvic Medicine & Reconstructive Surgery Clinic

    Sioux Falls, South Dakota, 57105, United States

  • Stony Brook University Hospital

    Stony Brook, New York, 11794, United States

  • Summit Health Englewood

    Englewood, New Jersey, 07631, United States

  • Summit Health Voorhees

    Voorhees Township, New Jersey, 08043, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Texas Medical Branch

    Galveston, Texas, 77555, United States

  • Urology Centers of Alabama

    Homewood, Alabama, 35209, United States

  • Urology Partners of North Texas Research Institute

    Arlington, Texas, 46017, United States

  • Urology Surgeons of Oklahoma

    Oklahoma City, Oklahoma, 73120, United States

  • Virginia Mason Medical Center

    Seattle, Washington, 98101, United States

  • Wright State Physicians

    Fairborn, Ohio, 45234, United States

More trials for these conditions

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