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New wearable device could zap overactive bladder symptoms without surgery

NCT ID NCT03784170

Symptom relief Sponsor: FemPulse Corporation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed trial tested a new non-implanted device that uses mild electrical stimulation to help control overactive bladder in women. 21 women with the condition used the FemPulse System, and researchers tracked side effects, urinary frequency, urgency, and quality of life. The goal was to see if the device is safe and can ease symptoms without the need for drugs or implants.

What this could mean

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

Active substance
FemPulse System (non-implanted electrical stimulation device)
What this could lead to
If it works, this could offer women with overactive bladder a non-surgical, drug-free option to reduce frequent urination and urgency.
What could go wrong
This was a very small early study (21 women) with no control group, so results may not apply broadly. The device may cause discomfort or fail to improve symptoms for some users.

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

21 people

The number who actually took part.

Started

Dec 2018

Finished

Dec 2019

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

21 years and older

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: * Females 21 years or older with a diagnosis of Overactive Bladder * If of reproductive age, must use a reliable form of contraception Exclusion Criteria: * Pregnant, was recently pregnant or is trying to conceive * Has a metal pelvic implant or any electrically active implanted medical device * Had a previous hysterectomy, pelvic radiation or pelvic cancer * Has significant pelvic organ prolapse * Had bladder treatment with onabotulinumtoxinA in the previous 12 months * Has a significant heart condition

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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.

Urinary bladder, overactive

Contacts and locations

Locations

  • McKay Urology

    Charlotte, North Carolina, 28207, United States

  • Minnesota Urology

    Woodbury, Minnesota, 55125, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

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