Pain Management, Pelvic Pain, Postoperative Pain After Uterine Fibroid Embolization, Uterine Fibroids, Uterine Fibroids (UF)
Conditions
Keywords
Transmucosal Uterosacral Electrical Stimulation, TUNES, Uterine Fibroid Embolization, UFE, Post-UFE Pain, Electrical Stimulation Therapy, Pelvic Pain Relief, Noninvasive Neuromodulation, Weill Cornell Medicine
Brief 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.
Detailed 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. The study will assess the feasibility, tolerability, and safety of this approach and explore whether this type of targeted stimulation may support improved comfort during early recovery. Findings from this work may help guide future investigation of transvaginal electrical stimulation as a potential adjunct to post-procedural pain management.
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.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants and investigators are blinded to treatment allocation. Only the unblinded device technician will know whether the device is active or inactive.
Eligibility
Sex/Gender
FEMALE
Age
28 Years to 52 Years
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 to fibroids * Known allergy or sensitivity to medical-grade silicone * Participation in another interventional study within 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean number of patient-controlled analgesia (PCA) activations within 12 hours after uterine fibroid embolization | Up 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean stimulation intensity over time during TUNES therapy | 0 to 12 hours post-UFE | For participants in the active and sham TUNES arms, the average stimulation intensity (measured in mA) will be recorded hourly during the 0-12 hour period following UFE. This measure assesses tolerance, comfort, and consistency of device use throughout this post-UFE window. |
| Mean visual analog scale (VAS) pain score within 23 hours after uterine fibroid embolization | Up to 23 hours post-UFE | Pain intensity will be measured using a standard 0-10 visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable. VAS scores will be collected periodically during the first 23 hours post-UFE. The mean VAS score will be compared across the active TUNES, sham TUNES, and control arms to evaluate potential differences in perceived pain. |
Countries
United States
Contacts
CONTACTMaurice Hurd, M.A.
CONTACTMarc Schiffman, M.D.
PRINCIPAL_INVESTIGATORMarc Schiffman
Weill Medical College of Cornell University
Outcome results
None listed