Not Yet RecruitingNot Applicable

Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief

United States60 participantsStarted 2026-04-01

Plain-language summary

This study will test whether gentle electrical stimulation to nerves near the uterus can reduce pelvic pain after uterine fibroid embolization. The investigators hypothesize that participants receiving active TUNES stimulation will experience lower pain levels and improved early recovery compared to those receiving sham stimulation or standard care.

Who can participate

Age range

28 Years – 52 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean number of patient-controlled analgesia (PCA) activations within 12 hours after uterine fibroid embolization

Timeframe: Up to 12 hours post-UFE

Trial details

NCT IDNCT07501676

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Maurice Hurd, M.A.

646-962-8690 mah4011@med.cornell.edu

View on ClinicalTrials.gov More Postoperative Pain After Uterine Fibroid Embolization trials