Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT07501676
Status
Not Yet Recruiting

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Conditions

  • Pain Management
  • Pelvic Pain
  • Postoperative Pain After Uterine Fibroid Embolization
  • Uterine Fibroids
  • Uterine Fibroids (UF)

Eligibility Criteria

Sex
FEMALE
Age
28 Years - 52 Years
Healthy Volunteers
Not accepted

Interventions

  • TUNES (Transmucosal Uterosacral Electrical Stimulation) — DEVICE
    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 — 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.

Study Details

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 Dates

Start date
Apr 1, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active TUNES Device
    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).
  • Sham Comparator: Sham TUNES Device
    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.
  • No Intervention: Standard Care Control
    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.

Primary Outcome Measure

Mean number of patient-controlled analgesia (PCA) activations within 12 hours after uterine fibroid embolization [ Time Frame: Up to 12 hours post-UFE ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10022
Marc Schiffman, M.D.
[email protected]
646-962-9185
Maurice Hurd, M.A.
[email protected]
Marc Schiffman, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Weill Cornell Medicine· New York, NY

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