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Could a tiny electrical zap ease pelvic pain after fibroid procedure?

NCT ID NCT07501676

Symptom relief Sponsor: Weill Medical College of Cornell University 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a device called TUNES, which delivers gentle electrical stimulation through a menstrual disc to nerves near the uterus. The goal is to see if it can reduce pain and the need for pain medication in 60 women after uterine fibroid embolization. Participants will be randomly assigned to active TUNES, a sham device, or standard care, and pain levels will be compared.

What this could mean

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

Active substance
TUNES device (transvaginal electrical stimulation)
What this could lead to
If it works, this could offer a non-drug option for managing pain after uterine fibroid embolization.
What could go wrong
This is a small, early-stage trial (60 participants) testing a device for short-term pain relief. It may not show a significant benefit over sham or standard care.

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 60 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

28 to 52 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, 28-52 years of age * Scheduled to undergo uterine fibroid embolization (UFE) at Weill Cornell Medicine * Able to provide informed consent * Willing to comply with all study procedures and follow-up * Fluent in English (for completion of study assessments) Exclusion Criteria: * Known or suspected pregnancy * Active pelvic infection * History of pelvic inflammatory disease within the past 6 months * Implanted electrical device (e.g., pacemaker, neurostimulator) * Current use of opioid pain medication prior to procedure * History of chronic pelvic pain not related to fibroids * Known allergy or sensitivity to medical-grade silicone * Participation in another interventional study within 30 days

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Conditions

The condition(s) this trial relates to.

agnosia leiomyoma Pelvic Pain uterine corpus leiomyoma

As listed by the trial registrant

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

Pain management Pelvic pain Postoperative pain after uterine fibroid embolization Uterine fibroids Uterine fibroids (UF)

How to take part

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

  1. The places running it

    1 site. 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

  • Weill Cornell Medicine

    New York, New York, 10022, United States

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