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L'essai clinique NCT07501676 (TUNES) pour Postoperative Pain After Uterine Fibroid Embolization, Uterine Fibroids (UF), Fibromes utérins, Douleur pelvienne, Gestion de la douleur est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief (TUNES) 60

Pas encore en recrutement
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L'essai clinique NCT07501676 (TUNES) est une étude interventionnel pour Postoperative Pain After Uterine Fibroid Embolization, Uterine Fibroids (UF), Fibromes utérins, Douleur pelvienne, Gestion de la douleur. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 avril 2026, avec un objectif de 60 participants. Dirigée par Weill Medical College of Cornell University, l'étude devrait être terminée d'ici le 30 septembre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 30 mars 2026.
Résumé succinct
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.
Description détaillée
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...Afficher plus
Titre officiel

Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief

Pathologies
Postoperative Pain After Uterine Fibroid EmbolizationUterine Fibroids (UF)Fibromes utérinsDouleur pelvienneGestion de la douleur
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'étude
  • TUNES
  • 25-10029448
Numéro NCT
NCT07501676
Date de début (réel)
2026-04-01
Dernière mise à jour publiée
2026-03-30
Date de fin (estimée)
2026-09-30
Inscription (estimée)
60
Type d'étude
Interventionnel
PHASE
N/A
Statut
Pas encore en recrutement
Mots clés
Transmucosal Uterosacral Electrical Stimulation
TUNES
Uterine Fibroid Embolization
UFE
Post-UFE Pain
Electrical Stimulation Therapy
Pelvic Pain Relief
Noninvasive Neuromodulation
Weill Cornell Medicine
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Double aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalActive 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...Afficher plus
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 ...Afficher plus
Comparateur facticeSham 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.
Aucune 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
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
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
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
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
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Adulte
Âge minimum
28 Years
Sexes éligibles
Femme
  • 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 logoWeill Medical College of Cornell University
Contact central de l'étude
Contact: Maurice Hurd, M.A., 646-962-8690, [email protected]
Contact: Marc Schiffman, M.D., 646-962-9185, [email protected]
1 Centres de l'étude dans 1 pays

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., Investigateur principal