Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief
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.
Description
Pelvic pain after uterine fibroid embolization (UFE) is common and can slow recovery and increase the need for pain medication. There is growing interest in non-pharmacologic options that may help manage this discomfort. The TUNES device delivers gentle electrical stimulation through a vaginally placed disc, targeting sensory nerves involved in pelvic pain pathways. The components and stimulation levels fall within established safety parameters for similar FDA-cleared technologies. In this pilot study, participants will use the device for a short period after UFE under clinician supervision.…
Eligibility
- Age range
- 28–52 years
- Sex
- Female
- Healthy volunteers
- No
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…
Interventions
- DeviceTUNES (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).
- DeviceSham 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.
Location
- Weill Cornell MedicineNew York, New York