[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631514":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":38,"centralContacts":42,"locations":52,"responsibleParty":69,"collaborators":24,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":24,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":94,"overallStatus":102,"whyStopped":24,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Weill Medical College of Cornell University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"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).",[13],"Device: TUNES (Transmucosal Uterosacral Electrical Stimulation)",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Device: Sham TUNES Device",{"label":21,"type":22,"description":23,"interventionNames":24},"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.",null,[26,35],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"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).",[9],[32,33,34],"Transvaginal Electrical Stimulation","TUNES Device","TUNES System",{"type":27,"name":15,"description":36,"armGroupLabels":37,"otherNames":24},"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.",[15],[39],{"name":40,"affiliation":5,"role":41},"Marc Schiffman","PRINCIPAL_INVESTIGATOR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":24,"email":47},"Maurice Hurd, M.A.","CONTACT","646-962-8690","mah4011@med.cornell.edu",{"name":49,"role":45,"phone":50,"phoneExt":24,"email":51},"Marc Schiffman, M.D.","646-962-9185","mas9252@med.cornell.edu",[53],{"facility":54,"status":24,"city":55,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Weill Cornell Medicine","New York","10022","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-74.00597,40.71427,{"lat":63,"lon":62},[66,67,68],{"name":49,"role":45,"phone":50,"phoneExt":24,"email":51},{"name":44,"role":45,"phone":24,"phoneExt":24,"email":47},{"name":49,"role":41,"phone":24,"phoneExt":24,"email":24},{"type":70,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100631514","transmucosal-uterosacral-electrical-stimulation-for-pelvic-pain-relief-100631514",false,"NCT07501676","Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief","TUNES","Inclusion Criteria:\n\n* Female, 28-52 years of age\n* Scheduled to undergo uterine fibroid embolization (UFE) at Weill Cornell Medicine\n* Able to provide informed consent\n* Willing to comply with all study procedures and follow-up\n* Fluent in English (for completion of study assessments)\n\nExclusion Criteria:\n\n* Known or suspected pregnancy\n* Active pelvic infection\n* History of pelvic inflammatory disease within the past 6 months\n* Implanted electrical device (e.g., pacemaker, neurostimulator)\n* Current use of opioid pain medication prior to procedure\n* History of chronic pelvic pain not related to fibroids\n* Known allergy or sensitivity to medical-grade silicone\n* Participation in another interventional study within 30 days","FEMALE","28 Years","52 Years",{"count":82,"type":83},60,"ESTIMATED","INTERVENTIONAL",[86],"NA","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.",[89,90,91,92,93],"Postoperative Pain After Uterine Fibroid Embolization","Uterine Fibroids (UF)","Uterine Fibroids","Pelvic Pain","Pain Management",[95,76,96,97,98,99,100,101,54],"Transmucosal Uterosacral Electrical Stimulation","Uterine Fibroid Embolization","UFE","Post-UFE Pain","Electrical Stimulation Therapy","Pelvic Pain Relief","Noninvasive Neuromodulation","NOT_YET_RECRUITING","2026-03-24",{"date":105,"type":106},"2026-03-30","ACTUAL",{"date":108,"type":83},"2026-04-01",{"date":110,"type":83},"2026-09-30",{"name":5,"class":6},1]