Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief
Key facts
- Who runs it
- Weill Medical College of Cornell University
- Where
- New York, United StatesSee the site
- Trial code
- Status
- Not yet recruiting
- People taking part
- 60 people, planned
- Started
- 1 Apr 2026
- Planned end
- 30 Sept 2026
- Type of study
- Interventional, 3 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- TUNES (Transmucosal Uterosacral Electrical Stimulation)
- Sham TUNES Device
- Record updated
- 30 March 2026
Who can take part
- Age
- 28 years to 52 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Current use of opioid pain medication prior to procedure
- Active pelvic infection
- History of pelvic inflammatory disease within the past 6 months
- History of chronic pelvic pain not related to fibroids
- Known allergy or sensitivity to medical-grade silicone
- Known or suspected pregnancy
- Implanted electrical device (e.g., pacemaker, neurostimulator)
- Participation in another interventional study within 30 days
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 28 and 52 years old?
Where in United States
- Weill Cornell MedicineNew York, United StatesContact: Marc Schiffman, M.D.Not yet recruiting
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Active TUNES DeviceTreatment being tested
Participants will receive the active TUNES device, which delivers low-amplitude transvaginal electrical stimulation (0-10 mA, 80-120 Hz, 100-200 µs pulse width) using a modified menstrual disc with stainless-steel electrodes. Stimulation targets the uterosacral ligaments and associated nerve plexuses involved in pelvic pain. Sessions last 20 minutes each hour for up to 12 hours after uterine fibroid embolization (UFE).
Treatment: TUNES (Transmucosal Uterosacral Electrical Stimulation)
- Sham TUNES DeviceSham treatment, for comparison
Participants will receive an identical TUNES device that appears and feels the same as the active version but delivers no electrical current. The device will be placed for the same duration and under the same conditions as the active arm to maintain blinding and control for placebo effects.
- Standard Care ControlNo study treatment, for comparison
Participants will receive standard post-procedure care following uterine fibroid embolization, including access to patient-controlled analgesia (PCA) and non-opioid pain medications as clinically indicated. No TUNES device will be used in this arm.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT07501676, who can take part
- Record updated
- 30 March 2026