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Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief
Sponsor: Weill Medical College of Cornell University
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.
Key Details
Gender
FEMALE
Age Range
28 Years - 52 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-04-01
Completion Date
2026-09-30
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
TUNES (Transmucosal Uterosacral Electrical Stimulation)
The TUNES device delivers low-amplitude transvaginal electrical stimulation (0-10 mA, 80-120 Hz, 100-200 µs pulse width) through stainless steel electrodes embedded in a modified menstrual disc. The device targets sensory nerves near the uterosacral ligaments and Frankenhauser plexus involved in pelvic pain signaling. It is powered by an FDA-cleared portable TENS unit (TENS 7000®). The stimulation is administered in 20-minute sessions each hour for up to 12 hours following uterine fibroid embolization (UFE).
Sham TUNES Device
A non-functioning version of the TUNES device that is identical in appearance, placement, and handling but delivers no electrical stimulation. It is used to maintain blinding and control for placebo effects.
Locations (1)
Weill Cornell Medicine
New York, New York, United States