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

New implant aims to quiet bladder urgency for years

NCT ID NCT07456865

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 6 times

Summary

This study is checking how well the Altaviva™ device works over five years for people with sudden, strong urges to urinate (urge incontinence). The device sends mild electrical pulses to a nerve in the ankle to calm bladder signals. Researchers will track 256 adults to see if at least half of them get a 50% or greater reduction in leakage episodes each year.

What this could mean

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

Active substance
Altaviva™ system (implantable neurostimulation device)
What this could lead to
If successful, this could confirm a durable, long-term treatment option for people with urge urinary incontinence who do not respond well to medication.
What could go wrong
This is an observational post-approval study, not a randomized controlled trial. Results may be influenced by patient selection and lack of a control group. Device-related risks include infection, discomfort, or need for removal.

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

About 256 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Nov 2032

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

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. Candidate for Altaviva™ therapy per Altaviva™ labeling 2. Have a diagnosis of UUI as demonstrated on a 3-day voiding diary by having a minimum of 3 episodes of urinary urge incontinence in 72 hours 3. If taking OAB medications, subjects should be on a stable dose for at least 3 months prior to baseline and willing to remain on stable treatment through completion of the 12-month voiding diary 4. Patient must be willing and able to accurately complete study questionnaires, attend visits, operate the system, and comply with the study protocol 5. Willing and able to provide signed and dated informed consent Exclusion Criteria: 1. Patient who is not a candidate for Altaviva™ therapy per Altaviva™ labeling, including: * Patients who are considered to be poor surgical candidates or who are at risk for poor wound healing per Altaviva™ labeling * Have progressive, systemic neurological disease * Have clinically significant peripheral neuropathy in the lower leg * Severe, uncontrolled diabetes 2. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component based on physician judgment 3. Current symptomatic urinary tract infection 4. Patients who have been treated with percutaneous tibial nerve stimulation (PTNS)/percutaneous tibial neuromodulation (PTNM) therapy in the past 4 weeks, or longer if the investigator judges that the therapeutic effect is still present 5. Patients who have had treatment of urinary symptoms with botulinum toxin therapy or sacral neuromodulation in the past 6 months 6. History of a prior implantable tibial neuromodulation system 7. Patients who are pregnant or planning to become pregnant during the course of the study 8. Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound study results

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Urge urinary incontinence are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

overactive bladder Urinary Incontinence, Urge

As listed by the trial registrant

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

Urge urinary incontinence

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Central Ohio Urology Group

    RECRUITING

    Gahanna, Ohio, 43230, United States

  • Institute for Female Pelvic Medicine and Reconstructive Surgery

    RECRUITING

    Allentown, Pennsylvania, 18103, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Penn Medicine Washington Square

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Rosemark Women Care Specialists

    RECRUITING

    Idaho Falls, Idaho, 83404, United States

  • Sanford Female Pelvic Medicine & Reconstructive Surgery Clinic

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • Southern Urogynecology

    RECRUITING

    West Columbia, South Carolina, 29169-3456, United States

  • TriHealth Hatton Research Institute

    RECRUITING

    Cincinnati, Ohio, 45242, United States

  • UPNT Research Institute

    RECRUITING

    Arlington, Texas, 76017, United States

  • University Hospitals

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Urology Centers of Alabama

    RECRUITING

    Homewood, Alabama, 35209, United States

  • Urology Specialists

    RECRUITING

    Sioux Falls, South Dakota, 57108, United States

  • Urology Specialists of the Carolinas

    RECRUITING

    Greensboro, North Carolina, 27403, United States

  • Urology of Saint Louis

    RECRUITING

    St Louis, Missouri, 63141-8657, United States

More trials for these conditions

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