Clinical Efficacy Evaluation of Electroacupuncture as Adjuvant Therapy for Female Patients With Overactive Bladder
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: electroacupuncture, sham acupuncture.
- Кому может быть актуально
- Состояния в реестре: Overactive Bladder. Базовые параметры: 20 лет — 80 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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Обзор
Overactive bladder (OAB) is often accompanied by frequent urination and nocturia, and does not necessarily manifest as urge incontinence. Urgency to urinate and frequent urination can lead to psychological burdens, affect interpersonal relationships and reduce women's quality of life. Treatment of OAB includes lifestyle changes, behavioral therapy, drug therapy, neuromodulation, botulinum toxin therapy, and surgical intervention. At present, anticholinergic drugs are usually the first-line treatment for OAB, but the side effects of dry mouth often lead to poor patient compliance. Transcutaneous tibial nerve stimulation (PTNS) is a minimally invasive neuromodulation technique. Past studies have confirmed that PTNS has clinical efficacy in treating symptoms related to overactive bladder, while TCM's electroacupuncture is similar to PTNS. The main purpose of this study was to evaluate the specific acupoints in accordance with traditional Chinese medicine theory in women with OAB under conventional Western medicine treatment to evaluate the improvement of women's related urinary tract symptoms, quality of life and autonomic nervous system function.
Подробное описание
Overactive bladder (OAB) is often accompanied by frequent urination and nocturia, and does not necessarily manifest as urge incontinence. Urgency to urinate and frequent urination can lead to psychological burdens, affect interpersonal relationships and reduce women's quality of life.
Treatment of OAB includes lifestyle changes, behavioral therapy, drug therapy, neuromodulation, botulinum toxin therapy, and surgical intervention. At present, anticholinergic drugs are usually the first-line treatment for OAB, but the side effects of dry mouth often lead to poor patient compliance.
Transcutaneous tibial nerve stimulation (PTNS) is a minimally invasive neuromodulation technique. Past studies have confirmed that PTNS has clinical efficacy in treating symptoms related to overactive bladder, while TCM's electroacupuncture is similar to PTNS. The main purpose of this study was to evaluate the specific acupoints in accordance with traditional Chinese medicine theory in women with OAB under conventional Western medicine treatment to evaluate the improvement of women's related urinary tract symptoms, quality of life and autonomic nervous system function.
Вмешательства
- Устройство electroacupuncture
Electroacupuncture is a form of acupuncture where a small electric current is passed between pairs of acupuncture needles. According to some acupuncturists, this practice augments the use of regular acupuncture, can restore health and well-being, and is particularly good for treating pain. - Устройство sham acupuncture
Acupuncture does not penetrate the skin, and the electroacupuncture machine is not plugged in.
Первичные конечные точки
- Urinary tract related questionnair [Срок оценки: Study spans 8 weeks: initial data collection, biweekly collections, 1-week break after 6 weeks, final collection in week 8. 5 questionnaire rounds in total. Proposed timeline.]
- King's Health Quality of Life Questionnaire(KHQ) [Срок оценки: Study spans 8 weeks: initial data collection, biweekly collections, 1-week break after 6 weeks, final collection in week 8. 5 questionnaire rounds in total. Proposed timeline.]
- Heart rate variability(HRV) [Срок оценки: Study spans 8 weeks: initial data collection, biweekly collections, 1-week break after 6 weeks, final collection in week 8. 5 questionnaire rounds in total. Proposed timeline.]
Вторичные конечные точки (2)
- Is the dose of the drug reduced? [Срок оценки: Every week will record the dose that participants take.A total of 8 weeks.]
- Are the side effects reduced? [Срок оценки: Every week will record side effects of taking medicine.A total of 8 weeks.]
Критерии участия
Критерии включения
- Female patient aged 20-80 with overactive bladder.
Критерии исключения
- Patient has history of cancer, stroke, or hyperthyroidism..
- Patient isn't willing to accept acupuncture or moxibustion treatment.
- Patient who is pregnant or plan to pregnant.
- Patient with urinary tract infection.
- Patient who had injection of botulinum toxin (Botox®), PTNS or SMN treatment before.
- Patient recieved acupuncture treatment before.
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
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Тайвань · 1 центр
- Buddhist Taipei Tzu Chi General Hospital — New Taipei City
Идентификаторы
NCT: NCT05997992 · 11-XD-071