The Efficacy of Transcutaneous Tibial Nerve Stimulation in Women With Idiopathic 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: Transcutaneous Tibial Nerve Stimulation, sham Transcutaneous Tibial Nerve Stimulation.
- Кому может быть актуально
- Состояния в реестре: Overactive Bladder. Базовые параметры: 18 лет — 50 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
- Turkey (Türkiye)
- 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
Investigation of the Efficacy of Transcutaneous Tibial Nerve Stimulation in the Treatment of Women Diagnosed With Idiopathic Overactive Bladder
Обзор
This study will be conducted on women of reproductive age diagnosed with idiopathic overactive bladder who either do not want to use drug treatment or cannot tolerate it due to side effects. Our aim is to examine the effects of a treatment method called transcutaneous tibial nerve stimulation on overactive bladder symptoms, urine flow measurements (uroflowmetry), post-voiding residue, pelvic floor muscle activity, heart rate variability, and quality of life in these individuals.
Вмешательства
- Другое Transcutaneous Tibial Nerve Stimulation
The treatment will be conducted twice a week for 30 minutes each time, for a total of 12 sessions over 6 weeks. - Другое sham Transcutaneous Tibial Nerve Stimulation
Sham Transcutaneous Tibial Nerve Stimulation will be performed for 6 weeks, 2 days a week, for 30 minutes each day, for a total of 12 sessions.
Первичные конечные точки
- Incontinence Impact Questionnaire scale [Срок оценки: From enrollment to the end of treatment at 6 weeks]
- Overactive bladder validation score 8 [Срок оценки: From enrollment to the end of treatment at 6 weeks]
- Voiding volume [Срок оценки: From enrollment to the end of treatment at 6 weeks]
- Voiding time [Срок оценки: From enrollment to the end of treatment at 6 weeks]
- Maximum flow rate [Срок оценки: From enrollment to the end of treatment at 6 weeks]
- Time to reach maximum flow [Срок оценки: From enrollment to the end of treatment at 6 weeks]
- Average flow rate [Срок оценки: From enrollment to the end of treatment at 6 weeks]
- Post-voiding residual urine [Срок оценки: From enrollment to the end of treatment at 6 weeks]
- SDNN (msn) [Срок оценки: From enrollment to the end of treatment at 6 weeks]
- RMSSD (msn) [Срок оценки: From enrollment to the end of treatment at 6 weeks]
Критерии участия
Критерии включения
- Eligibility criteria include being between 18 and 50 years of age, having an overactive bladder validation score of 8 (AAM-V8) above 7, refusing or being unable to tolerate antimuscarinic or mirabegron treatment, and being able to understand and follow verbal stimuli.
Критерии исключения
- The following criteria were defined as contraindications: pelvic organ prolapse or other anatomical abnormality, being in the postmenopausal period, having used anticholinergic and/or mirabegron treatment within the last 4 weeks, being pregnant or planning to become pregnant during treatment, having an active genitourinary infection, having a mechanical obstruction in the bladder, having a neurological/congenital disorder, having undergone urogynecological surgery within the last 2 months, having concomitant stress incontinence, having previously received transcutaneous tibial nerve stimulation (TTNS) treatment, and having sensory loss in the area where the treatment will be applied.
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
Turkey (Türkiye) · 1 центр
- Inonu University — Malatya
Идентификаторы
NCT: NCT07463326 · 2025/7708 · TTU-2025-4064