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TUNES for Pelvic Pain After Uterine Fibroid Embolization

This study is testing a device called TUNES (Transmucosal Uterosacral Electrical Stimulation) to see if it can help reduce pelvic pain after uterine fibroid embolization (UFE). The TUNES device delivers gentle electrical stimulation through a modified menstrual disc to nerves near the uterus. Researchers want to know if this stimulation can lead to less pain and a better recovery compared to a non-working (sham) device. You may be eligible if you are a woman between 28 and 52 years old, scheduled for UFE at Weill Cornell Medicine, and can speak English. The main goal is to see if participants use less pain medication in the first 12 hours after UFE.

Study design
This is an interventional study planning to enroll 60 women. Participants will either receive the active TUNES device or a sham device, which looks identical but provides no stimulation.
What's involved
Participants will use the device for a short period after UFE under clinician supervision. The study will assess feasibility, tolerability, and safety.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured up to 12 hours after UFE.

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NCT07501676

Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief

Not Yet Recruiting
NAAges 28–52InterventionalTreatment
Weill Medical College of Cornell University
~60 participants
Updated 2026-03-30 on ClinicalTrials.gov
What's tested:TUNES (Transmucosal Uterosacral Electrical Stimulation)Sham TUNES Device

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean number of patient-controlled analgesia (PCA) activations within 12 hours after uterine fibroid embolization
Measured over Up to 12 hours post-UFE

Conditions

Postoperative Pain After Uterine Fibroid Embolization
Uterine Fibroids (UF)
Uterine Fibroids
Pelvic Pain
Pain Management

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Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Marc Schiffman · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University

Who to contact

Maurice Hurd, M.A.
[email protected]
646-962-8690
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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Mean number of patient-controlled analgesia (PCA) activations within 12 hours after uterine fibroid embolizationUp to 12 hours post-UFE

    The mean number of patient-controlled analgesia (PCA) pump activations (button presses) within the first 12 hours after uterine fibroid embolization will be recorded. This measure reflects the frequency of patient-initiated pain medication use and serves as a quantitative indicator of post-procedural pain intensity. The mean number of activations will be compared across the active TUNES, sham TUNES, and control arms.