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New device aims to quiet an overactive bladder without drugs

NCT ID NCT07209397

Symptom relief Sponsor: InMode MD Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a device that uses radiofrequency energy inside the vagina to treat overactive bladder in women. It includes 202 women aged 22 to 80 who have had symptoms for at least 6 months. Half will get the real treatment and half a sham (fake) treatment to see if the device safely reduces urgent urine leaks.

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 202 people

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

Started

Nov 2025

Expected to finish

Nov 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.

Ages

22 to 80 years

Sex

Female participants only

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: * Female, aged 22 to 80 years inclusive at the time of consent. * History of idiopathic overactive bladder (OAB) symptoms for ≥6 months. * At least 7 episodes of urge urinary incontinence (UUI) over 3 days, as recorded in a 3-day bladder diary during screening. * Urge-predominant incontinence, defined as greater number of UUI episodes than stress urinary incontinence (SUI) episodes during screening. * Willing and able to complete the 3-day bladder diary. * Willing to discontinue OAB medications (e.g., anticholinergics, beta-3 agonists) at least 2 weeks prior to baseline treatment visit, if currently taking such medications. * Willing to use a reliable method of contraception during the study period, if of childbearing potential and sexually active. * Negative pregnancy test at screening (if applicable). * Willing and able to provide written informed consent and comply with study procedures and follow-up schedule. EXCLUSION CRITERIA: * Predominant stress urinary incontinence (SUI) based on bladder diary * Currently pregnant, breastfeeding, or planning pregnancy during the study * History of neurologic conditions affecting bladder function (e.g., multiple sclerosis, spinal cord injury, Parkinson's disease) * Active urinary tract infection (UTI) at screening * History of interstitial cystitis, bladder pain syndrome, or chronic pelvic pain * Prior or current bladder cancer, pelvic malignancy, or pelvic radiation * Pelvic organ prolapse beyond the hymen (POP-Q stage \> II) * Implanted neuromodulation device or prior sacral nerve stimulation * Use of bulking agents, Botox, or surgical treatment for incontinence within 12 months * Prior pelvic floor RF treatment or laser vaginal rejuvenation * Significant pelvic anatomical abnormalities that interfere with treatment * Use of investigational drug or device within 30 days before screening * Any condition that, in the investigator's opinion, would interfere with safe study participation or data integrity * Uncontrolled systemic disease (e.g., uncontrolled diabetes, cardiovascular disease) * Inability or unwillingness to comply with study requirements or follow-up

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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.

Idiopathic overactive bladder Idiopathic overactive bladder with urinary incontinence Mixed urinary incontinence Mixed urinary incontinence (urge-predominant) Overactive bladder Overactive bladder (OAB) 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

    9 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

  • Advanced Specialty Research

    RECRUITING

    Boise, Idaho, 83702, United States

  • Atrium Health Wake Forest Female Pelvic Health Division

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • Bay State Clinical Trials

    RECRUITING

    Watertown, Massachusetts, 02472, United States

  • Cypress Medical Research Center

    RECRUITING

    Wichita, Kansas, 67226, United States

  • MedStar Health Research Institute

    NOT_YET_RECRUITING

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

  • Stanford Medicine Department of Obstetrics & Gynecology

    NOT_YET_RECRUITING

    Palo Alto, California, 94304, United States

  • UNLV Kirk Kerkorian School of Medicine Department of Gynecologic Surgery & Obstetrics

    NOT_YET_RECRUITING

    Las Vegas, Nevada, 89154, United States

  • University of Chicago Medicine Urogynecology

    NOT_YET_RECRUITING

    Chicago, Illinois, 60062, United States

  • Urology Center, P.C.

    RECRUITING

    Omaha, Nebraska, 68114, United States

More trials for these conditions

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