NCT07501676

Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: Female
• Age: 28 Years – 52 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	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 20-minute sessions each hour for up to 12 hours following uterine fibroid embolization (UFE).
DEVICE	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study