Clinical Trial Radar

Name: Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief
Creator: Weill Medical College of Cornell University
Published: 2026-03-30
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT07501676 (TUNES) for Postoperative Pain After Uterine Fibroid Embolization, Uterine Fibroids (UF), Uterine Fibroids, Pelvic Pain, Pain Management is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief (TUNES) 60

Not yet recruiting

Clinical Trial NCT07501676 (TUNES) is an interventional study for Postoperative Pain After Uterine Fibroid Embolization, Uterine Fibroids (UF), Uterine Fibroids, Pelvic Pain, Pain Management and is currently not yet recruiting. Enrollment is planned to begin on 1 April 2026 and continue until the study accrues 60 participants. Led by Weill Medical College of Cornell University, this study is expected to complete by 30 September 2026. The latest data from ClinicalTrials.gov was last updated on 30 March 2026.

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 e...Show More

Official Title

Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief

Conditions

Postoperative Pain After Uterine Fibroid EmbolizationUterine Fibroids (UF)Uterine FibroidsPelvic PainPain Management

Publications

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.

Other Study IDs

TUNES
25-10029448

NCT ID Number

NCT07501676

Start Date (Actual)

2026-04-01

Last Update Posted

2026-03-30

Completion Date (Estimated)

2026-09-30

Enrollment (Estimated)

Study Type

Interventional

PHASE

N/A

Status

Not yet recruiting

Keywords

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

Primary Purpose

Treatment

Design Allocation

Randomized

Interventional Model

Parallel

Masking

Double

Arms / Interventions

Participant Group/Arm	Intervention/Treatment
ExperimentalActive 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...Show More	TUNES (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 ...Show More
Sham ComparatorSham 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.	Sham 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.
No InterventionStandard 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.	N/A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean stimulation intensity over time during TUNES therapy	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.	0 to 12 hours post-UFE
Mean visual analog scale (VAS) pain score within 23 hours after uterine fibroid embolization	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.	Up to 23 hours post-UFE

Participation Assistant

Eligibility Criteria

Eligible Ages

Adult

Minimum Age

28 Years

Eligible Sexes

Female

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)

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

Weill Medical College of Cornell University

Study Central Contact

Contact: Maurice Hurd, M.A., 646-962-8690, [email protected]

Contact: Marc Schiffman, M.D., 646-962-9185, [email protected]

1 Study Locations in 1 Countries

United States

New York

Weill Cornell Medicine, New York, New York, 10022, United States

Marc Schiffman, M.D., Contact, 646-962-9185, [email protected]

Maurice Hurd, M.A., Contact, [email protected]

Marc Schiffman, M.D., Principal Investigator

Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief (TUNES) 60

Inclusion Criteria

Exclusion Criteria