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Набор скоро начнётся NCT07501676

Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief

Без фазы С лечением Postoperative Pain After Uterine Fibroid Embolization Uterine Fibroids (UF) Uterine Fibroids Pelvic Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: TUNES (Transmucosal Uterosacral Electrical Stimulation), Sham TUNES Device.
Кому может быть актуально
Состояния в реестре: Postoperative Pain After Uterine Fibroid Embolization, Uterine Fibroids (UF), Uterine Fibroids, Pelvic Pain. Базовые параметры: 28 лет — 52 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство 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 emboli
  • Устройство 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.

Первичные конечные точки

  • Mean number of patient-controlled analgesia (PCA) activations within 12 hours after uterine fibroid embolization [Срок оценки: Up to 12 hours post-UFE]
Вторичные конечные точки (2)
  • Mean stimulation intensity over time during TUNES therapy [Срок оценки: 0 to 12 hours post-UFE]
  • Mean visual analog scale (VAS) pain score within 23 hours after uterine fibroid embolization [Срок оценки: Up to 23 hours post-UFE]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Weill Cornell Medicine — New York

Публикации

  • 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. PMID 22525915
  • Radtke S, Boren T, Depasquale S. Paracervical Block as a Strategy to Reduce Postoperative Pain after Laparoscopic Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2019 Sep-Oct;26(6):1164-1168. doi: 10.1016/j.jmig.2018.12.001. Epub 2018 Dec 6. PMID 30528725
  • de Bernardes NO, Marques A, Ganunny C, Bahamondes L. Use of intravaginal electrical stimulation for the treatment of chronic pelvic pain: a randomized, double-blind, crossover clinical trial. J Reprod Med. 2010 Jan-Feb;55(1-2):19-24. PMID 20337203
  • de Oliveira Bernardes N, Bahamondes L. Intravaginal electrical stimulation for the treatment of chronic pelvic pain. J Reprod Med. 2005 Apr;50(4):267-72. PMID 15916211
  • Fuentes-Marquez P, Cabrera-Martos I, Valenza MC. Physiotherapy interventions for patients with chronic pelvic pain: A systematic review of the literature. Physiother Theory Pract. 2019 Dec;35(12):1131-1138. doi: 10.1080/09593985.2018.1472687. Epub 2018 May 14. PMID 29757068
  • Mendes CF, Oliveira LS, Garcez PA, Azevedo-Santos IF, DeSantana JM. Effect of different electric stimulation modalities on pain and functionality of patients with pelvic pain: Systematic review with META-analysis. Pain Pract. 2024 Oct 14. doi: 10.1111/papr.13417. Online ahead of print. PMID 39400976
  • Goodwin SC, Bradley LD, Lipman JC, Stewart EA, Nosher JL, Sterling KM, Barth MH, Siskin GP, Shlansky-Goldberg RD; UAE versus Myomectomy Study Group. Uterine artery embolization versus myomectomy: a multicenter comparative study. Fertil Steril. 2006 Jan;85(1):14-21. doi: 10.1016/j.fertnstert.2005.05.074. PMID 16412720
  • Pron G, Mocarski E, Bennett J, Vilos G, Common A, Zaidi M, Sniderman K, Asch M, Kozak R, Simons M, Tran C, Kachura J; Ontario UFE Collaborative Group. Tolerance, hospital stay, and recovery after uterine artery embolization for fibroids: the Ontario Uterine Fibroid Embolization Trial. J Vasc Interv Radiol. 2003 Oct;14(10):1243-50. doi: 10.1097/01.rvi.0000092664.72261.f9. PMID 14551270

Идентификаторы

NCT: NCT07501676 · 25-10029448

Первоисточники (государственные реестры)

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