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治験 NCT07501676 (TUNES)（対象：Postoperative Pain After Uterine Fibroid Embolization、Uterine Fibroids (UF)、子宮筋腫、骨盤痛、痛みの管理）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。
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Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief (TUNES) 60

募集準備中
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07501676 (TUNES) は 介入研究 臨床試験 で、Postoperative Pain After Uterine Fibroid Embolization、Uterine Fibroids (UF)、子宮筋腫、骨盤痛、痛みの管理 に関するものです。現在は 募集準備中 で、2026年4月1日 に開始予定です。60 名の参加者 の募集が計画されています。この試験は Weill Medical College of Cornell University によって主導され、2026年9月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月30日 です。
概要
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.
詳細説明
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...もっと見る
公式タイトル

Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief

疾患名
Postoperative Pain After Uterine Fibroid EmbolizationUterine Fibroids (UF)子宮筋腫骨盤痛痛みの管理
刊行物
この臨床試験について発表された科学記事と研究論文：
その他の研究識別子
  • TUNES
  • 25-10029448
NCT番号
NCT07501676
開始日
2026-04-01
最終更新日
2026-03-30
終了予定日
2026-09-30
目標参加者数
60
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集準備中
キーワード
Transmucosal Uterosacral Electrical Stimulation
TUNES
Uterine Fibroid Embolization
UFE
Post-UFE Pain
Electrical Stimulation Therapy
Pelvic Pain Relief
Noninvasive Neuromodulation
Weill Cornell Medicine
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
二重盲検
群（アーム）／介入
参加グループ/群介入/治療法
実験的Active 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...もっと見る
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 ...もっと見る
シャム対照薬Sham 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.
非介入Standard 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.
該当なし
主要評価項目
評価指標指標の説明時間枠
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
副次評価項目
評価指標指標の説明時間枠
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
参加アシスタント
適格基準

対象年齢
成人
試験の最低年齢
28 Years
対象性別
女性
  • 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
試験中央連絡先
連絡先: Maurice Hurd, M.A., 646-962-8690, [email protected]
連絡先: Marc Schiffman, M.D., 646-962-9185, [email protected]
1 1カ国の場所

New York

Weill Cornell Medicine, New York, New York, 10022, United States
Marc Schiffman, M.D., 連絡先, 646-962-9185, [email protected]
Maurice Hurd, M.A., 連絡先, [email protected]
Marc Schiffman, M.D., 主任研究者