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Идёт набор NCT07243028

Ultrasound and Electromyography Biofeedback for Pelvic Floor Muscle Training

Без фазы С лечением Pelvic Floor Dysfunction Pelvic Floor Muscle Weakness

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: Ultrasound Biofeedback Device, Manometer Biofeedback Device.
Кому может быть актуально
Состояния в реестре: Pelvic Floor Dysfunction, Pelvic Floor Muscle Weakness. Базовые параметры: от 21 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
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Application of Simultaneous Pelvic Floor Ultrasonography and Electromyography Biofeedback on Pelvic Floor Muscle Training

Обзор

This study aims to investigate the factors influencing adherence to pelvic floor muscle training (PFMT) devices among patients with pelvic floor dysfunction (PFD) through structured questionnaires, while simultaneously comparing the effectiveness of different feedback modalities, including non-invasive ultrasound imaging and invasive manometry with electromyography (EMG). By integrating subjective adherence data with objective performance outcomes, the project seeks to evaluate the potential of system-level integration for personalized therapeutic strategies, ultimately enhancing treatment efficacy, improving patient satisfaction, and promoting sustained engagement in PFMT.

Вмешательства

  • Устройство Ultrasound Biofeedback Device
    Application of trans-abdominal ultrasonography as a biofeedback tool during pelvic floor muscle training
  • Устройство Manometer Biofeedback Device
    Application of manometry as a biofeedback tool during pelvic floor muscle training. The manometer is a routinely used clinical device in hospital-based pelvic floor rehabilitation programs to provide quantitative intravaginal pressure feedback and guide patients in performing correct pelvic floor muscle contractions.

Первичные конечные точки

  • Bladder base displacement (cm) during pelvic floor muscle contractions measured by transabdominal ultrasound [Срок оценки: Baseline and at each of the six pelvic floor muscle training sessions (Sessions 1-6). The six training sessions will be completed within approximately one month, and study parameters will be measured at each of these six sessions by the research staff.]
  • Change in bladder base angle (degrees) relative to the horizontal line during pelvic floor muscle contractions measured by transabdominal ultrasound [Срок оценки: Baseline and at each of the six pelvic floor muscle training sessions (Sessions 1-6). The six training sessions will be completed within approximately one month, and study parameters will be measured at each of these six sessions by the research staff.]
  • Survey on Willingness to Use Pelvic Floor Muscle Training Devices [Срок оценки: A total of six pelvic floor muscle training sessions will be completed within approximately one month. Questionnaires will be administered at the 3rd session (midpoint of the treatment) and the 6th session (completion of all training sessions)]
Вторичные конечные точки (2)
  • Surface Electromyography [Срок оценки: At each of the six pelvic floor muscle training sessions (Sessions 1-6). The six training sessions will be completed within approximately one month, and outcome parameters will be measured at each of these six sessions by the research staff.]
  • Vaginal manometry measurement [Срок оценки: Measurements will be performed during either the 1st to 3rd sessions (approximately days 1-14 after baseline) or the 4th to 6th sessions (approximately days 15-30 after baseline), according to each participant's assigned randomization sequence.]

Критерии участия

Критерии включения

  • Women aged 21 years or older diagnosed with pelvic floor muscle dysfunction and requiring pelvic floor muscle training (e.g., for symptomatic pelvic organ prolapse, stress urinary incontinence, or dysfunctional voiding).
  • A Pelvic Floor Disability Index (PFDI-20) score greater than 1.
  • Ability and willingness to provide written informed consent and authorization for the release of personal health information.
  • Willingness and ability to complete all required questionnaires

Критерии исключения

  • Individuals planning a future pregnancy.
  • Inability to read, understand, or sign the written consent form prior to participation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Тайвань · 1 центр
  • National Cheng-Kung University Hospital — Tainan

Публикации

  • Chao YH, Chiang CJ, Tsai CH, Cheng YM, Kuo LC, Su FC. Adherence and continuance intention of biofeedback-assisted pelvic floor muscle training: a theory-driven study among women with pelvic floor disorders. BMC Womens Health. 2026 Jul 18. doi: 10.1186/s12905-026-04711-9. Online ahead of print. PMID 42471707

Идентификаторы

NCT: NCT07243028 · A-ER-112-385

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗