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Набор скоро начнётся NCT07265700

Is Treatment With FMS Tesla Chair Equal to Physiotherapy in First and Second-degree Urinary Incontinence?

Без фазы С лечением Urinary Incontinence

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: Tesla-Chair, Physiotherapy.
Кому может быть актуально
Состояния в реестре: Urinary Incontinence. Базовые параметры: от 18 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
Список центров уточняется — проверьте первичный протокол.
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

Monocentric Prospective, Randomized, Non-blinded, Active-controlled Trial to Evaluate the Non-inferiority of Functional Magnetic Stimulation (FMS) on the Tesla Chair Compared to Physiotherapy in First or Second-degree Urinary Incontinence

Обзор

100 patients with mild to moderate urinary incontinence will be randomly divided into two groups. One half will receive functional magnetic stimulation with the Tesla Chair for three months, while the other half will be treated with pelvic floor physiotherapy for the same period. After three and six months, a comparison will be made to determine which patient groups experience an improvement in urinary incontinence and how their muscle strength improves.

Подробное описание

Urinary incontinence is a debilitating condition that significantly impacts patients' quality of life, contributing to anxiety, depression, and social withdrawal. The severity of stress urinary incontinence (SUI) is directly correlated with increased physical and psychological burden. Although lifestyle modifications can offer moderate symptom relief, the current gold-standard first-line treatment is pelvic floor physiotherapy, with surgical intervention reserved for refractory cases.

Functional magnetic stimulation (FMS) has demonstrated positive effects in patients with urinary incontinence, including improvements in urodynamic parameters. However, limited research has directly compared the efficacy of FMS as a first-line therapy with standard pelvic floor physiotherapy. Addressing this gap is essential for informing clinical practice and expanding evidence-based therapeutic options. The efficacy of pelvic floor physiotherapy is commonly evaluated using the Oxford Scale, which provides an objective measure of pelvic floor muscle contraction strength. Additionally, patient-reported outcomes are assessed using validated instruments, including the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF UI) and the German Pelvic Floor Questionnaire (Deutscher Beckenbodenfragebogen), capturing symptom severity and quality of life. Together, these endpoints-objective assessments and patient-reported outcomes-offer a comprehensive evaluation of treatment effectiveness.

Вмешательства

  • Устройство Tesla-Chair
    Magnetic stimulation using the Tesla-Chair
  • Процедура Physiotherapy
    Pelvicfloor physiotherapy

Первичные конечные точки

  • Change in ICIQ-SF UI Score [Срок оценки: 3 months post-treatment (6 months from baseline)]
  • Change in ICIQ-SF UI Score [Срок оценки: 6-months post-treatment (9 months from baseline)]
Вторичные конечные точки (2)
  • Change in pelvic floor muscle strength, measured by the Oxford Scale [Срок оценки: 3 months post-treatment (6 months from baseline)]
  • Change in pelvic floor muscle strength, measured by the Oxford Scale [Срок оценки: 6 months post-treatment (9 months from baseline)]

Критерии участия

Критерии включения

  • Age ≥ 18 years
  • Urinary incontinence of first or second degree
  • Written informed consent
  • German speaking (Study information and IC available only in German)

Критерии исключения

  • Pregnancy or desire to become pregnant
  • Urinary incontinence of third degree
  • Third or fourth degree pelvic organ prolapses
  • no noticeable voluntary muscle activity according to Oxford = O/5
  • Genital infections
  • Malignant tumors
  • Severe neurological diseases
  • Cardiac arrhythmia
  • Active internal medical devices e.g. cardiac pacemakers, medication pumps etc.
  • Ferromagnetic implants at or near the site of stimulation
  • Recent surgery at the site of stimulation
  • Thrombosis or thrombophlebitis
  • Epilepsy or suspected epilepsy
  • Acute stages of kidney stones
  • Gastrointestinal and internal disease at the site of stimulation
  • Known or suspected non-compliance, drug or alcohol abuse
  • Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
  • Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation
  • Previous enrolment into the current investigation
  • Enrolment of the Sponsor or PI, their family members, employees and other dependent persons

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
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07265700 · Tesla-UI

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗