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New Nerve-Stimulating device tested for bladder control

NCT ID NCT07205445

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study is testing a new device called Tensi+ that uses mild electrical pulses to help people with overactive bladder. Researchers will track 500 adults for one year to see if the device improves symptoms like sudden urges to urinate. The goal is to learn how well it works and who benefits most.

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.

Participants

About 500 people

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

Started

Feb 2025

Expected to finish

Oct 2027

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.

Who is studied

Age ≥ 18 years Overactive bladder symptoms

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: * Age ≥ 18 years * Patients suffering from idiopathic or neurological overactive bladder Exclusion Criteria: * Patients with pacemaker, defibrillator, or any other electronic implant; * Patients with metal implant near the stimulation area; * Pregnant women; * People suffering from ankle joint problems, swollen ankles or a dermatological condition or damaged skin in the area where the electrodes are to be placed; * Patient with cognitive impairment; * Inability to complete a voiding diary; * No social security cover (for applicable countries).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    17 sites in 3 countries. 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

  • Addenbrooke's Hospital, Cambridge University Hospital Trust

    NOT_YET_RECRUITING

    Cambridge, CB22 0QQ, United Kingdom

  • Azienda Ospedaliero Universitaria Sant'Andrea

    NOT_YET_RECRUITING

    Roma, 00189, Italy

  • Azienda Ospedaliero Universitaria Sant'Andrea

    NOT_YET_RECRUITING

    Roma, 00189, Italy

  • Azienda Ospedaliero-Universitaria Careggi

    NOT_YET_RECRUITING

    Florence, 50139, Italy

  • Bristol Urological Institute

    NOT_YET_RECRUITING

    Bristol, BS10 5NB, United Kingdom

  • CHU de Rennes

    RECRUITING

    Rennes, 35033, France

  • CHU de Rennes

    RECRUITING

    Rennes, 35033, France

  • CHU de Rouen - Hôpital Charles Nicolle

    RECRUITING

    Rouen, 76031, France

  • Casa di Cura Villa Stuart

    NOT_YET_RECRUITING

    Roma, 00135, Italy

  • Clinica Nuova Villa Claudia

    NOT_YET_RECRUITING

    Roma, 00191, Italy

  • HFME - Hospices Civils de Lyon

    RECRUITING

    Bron, 69500, France

  • Hesperia Hospital

    NOT_YET_RECRUITING

    Modena, 41125, Italy

  • Nuova Villa Esther

    NOT_YET_RECRUITING

    Avellino, 83100, Italy

  • Policlinico Tor Vergata

    NOT_YET_RECRUITING

    Roma, 00133, Italy

  • Santa Maria la Gruccia Hospital

    NOT_YET_RECRUITING

    Montevarchi, 52025, Italy

  • University College Hospital London

    NOT_YET_RECRUITING

    London, NW1 2BU, United Kingdom

  • Villa Salaria Hospital

    NOT_YET_RECRUITING

    Roma, 00139, Italy

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