Electrical Stimulation for Pelvic Pain

(TUNES Trial)

This trial aims to determine if gentle electrical stimulation to nerves near the uterus can reduce pelvic pain after uterine fibroid embolization, a treatment to shrink non-cancerous growths in the uterus. Participants will receive either a real TUNES device (Transmucosal Uterosacral Electrical Stimulation) that provides electrical stimulation, a sham device that does not, or just standard care to assess effectiveness. Women scheduled for uterine fibroid embolization at Weill Cornell Medicine who can follow the study procedures and speak English may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance future treatment options.

The trial does not specify whether you need to stop taking your current medications. However, if you are using opioid pain medication, you cannot participate in the trial.

Research has shown that electrical stimulation, like the TUNES device, is usually well-tolerated. In past studies, similar treatments had low rates of serious side effects, with most issues being minor, such as slight discomfort during the procedure. This suggests that TUNES could be safe for many people.

The TUNES device uses gentle electrical currents to target nerves near the uterus, helping to reduce pelvic pain. As a non-invasive treatment, it often results in fewer complications than surgery.

Unlike the standard of care for pelvic pain, which often involves medications like NSAIDs or opioids, TUNES (Transmucosal Uterosacral Electrical Stimulation) offers a novel approach by targeting the uterosacral ligaments and nerve plexuses directly with electrical stimulation. This treatment uses a unique delivery method, a modified menstrual disc with stainless-steel electrodes, to provide low-amplitude electrical pulses. Researchers are excited about TUNES because it could provide targeted pain relief without the side effects associated with systemic medications, potentially offering a more effective and safer option for managing pelvic pain.

Research has shown that electrical stimulation, such as the TUNES device, can help reduce pelvic pain. In this trial, participants may receive the active TUNES device, which targets specific nerves near the uterus to ease pain after a fibroid-shrinking procedure. This therapy resembles TENS, known to relieve pain from conditions like painful periods and chronic pelvic pain. Although limited data exists on TUNES itself, its method relies on proven pain-relief techniques. Early results suggest it may improve recovery by directly targeting pain.¹²⁴⁵⁶