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NCT Number: NCT07501676

Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief

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.

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Key information

Conditions

Postoperative Pain After Uterine Fibroid Embolization Agnosia Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain Management Pathological Conditions, Signs and Symptoms Pelvic Pain Perceptual Disorders Signs and Symptoms Uterine Fibroids Uterine Fibroids (UF)

Age range

28 year–52 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Transvaginal Electrical Stimulation, TUNES Device, TUNES System

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.

Primary outcomes

  1. Mean number of patient-controlled analgesia (PCA) activations within 12 hours after uterine fibroid embolization

    Time frame: 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 outcomes

  1. Mean stimulation intensity over time during TUNES therapy

    Time frame: 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.

  2. Mean visual analog scale (VAS) pain score within 23 hours after uterine fibroid embolization

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marc Schiffman, M.D.

CONTACT

[email protected]

646-962-9185

Maurice Hurd, M.A.

CONTACT

[email protected]

646-962-8690

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Acronym: TUNES

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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