Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief

NCT07501676 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 25-10029448
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Transmucosal Uterosacral Electrical Stimulation; TUNES; Uterine Fibroid Embolization; UFE; Post-UFE Pain; Electrical Stimulation Therapy; Pelvic Pain Relief; Noninvasive Neuromodulation; Weill Cornell Medicine

Outcome Measures

Primary Outcomes (1)

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

  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.

  Up to 12 hours post-UFE

Secondary Outcomes (2)

• Mean stimulation intensity over time during TUNES therapy

  0 to 12 hours post-UFE

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

  Up to 23 hours post-UFE

Study Arms (3)

Active TUNES Device

EXPERIMENTAL

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).

Device: TUNES (Transmucosal Uterosacral Electrical Stimulation)

Sham TUNES Device

SHAM COMPARATOR

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.

Device: Sham TUNES Device

Standard Care Control

NO INTERVENTION

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.

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).

Also known as: Transvaginal Electrical Stimulation, TUNES Device, TUNES System

Active TUNES Device

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.

Sham TUNES Device

Eligibility Criteria

• Age: 28 Years - 52 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10022, United States

Location

Related Publications (8)

• Renner RM, Nichols MD, Jensen JT, Li H, Edelman AB. Paracervical block for pain control in first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2012 May;119(5):1030-7. doi: 10.1097/AOG.0b013e318250b13e.

  PMID: 22525915 BACKGROUND

• Radtke S, Boren T, Depasquale S. Paracervical Block as a Strategy to Reduce Postoperative Pain after Laparoscopic Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2019 Sep-Oct;26(6):1164-1168. doi: 10.1016/j.jmig.2018.12.001. Epub 2018 Dec 6.

  PMID: 30528725 BACKGROUND

• de Bernardes NO, Marques A, Ganunny C, Bahamondes L. Use of intravaginal electrical stimulation for the treatment of chronic pelvic pain: a randomized, double-blind, crossover clinical trial. J Reprod Med. 2010 Jan-Feb;55(1-2):19-24.

  PMID: 20337203 BACKGROUND

• de Oliveira Bernardes N, Bahamondes L. Intravaginal electrical stimulation for the treatment of chronic pelvic pain. J Reprod Med. 2005 Apr;50(4):267-72.

  PMID: 15916211 BACKGROUND

• Fuentes-Marquez P, Cabrera-Martos I, Valenza MC. Physiotherapy interventions for patients with chronic pelvic pain: A systematic review of the literature. Physiother Theory Pract. 2019 Dec;35(12):1131-1138. doi: 10.1080/09593985.2018.1472687. Epub 2018 May 14.

  PMID: 29757068 BACKGROUND

• Mendes CF, Oliveira LS, Garcez PA, Azevedo-Santos IF, DeSantana JM. Effect of different electric stimulation modalities on pain and functionality of patients with pelvic pain: Systematic review with META-analysis. Pain Practice 2025;25:e13417

  BACKGROUND

• Goodwin SC, Bradley LD, Lipman JC, et al. Uterine artery embolization versus myomectomy: a multicenter comparative study. Fertility and sterility 2006;85:14-21

  BACKGROUND

• Pron G, Mocarski E, Bennett J, et al. Tolerance, Hospital Stay, and Recovery after Uterine Artery Embolization for Fibroids: The Ontario Uterine Fibroid Embolization Trial. Journal of Vascular and Interventional Radiology 2003;14:1243-50.

  BACKGROUND

MeSH Terms

Conditions

Leiomyoma; Pelvic Pain; Agnosia

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Marc Schiffman

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maurice Hurd, M.A.

CONTACT

646-962-8690; mah4011@med.cornell.edu

Marc Schiffman, M.D.

CONTACT

646-962-9185; mas9252@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigators are blinded to treatment allocation. Only the unblinded device technician will know whether the device is active or inactive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)