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Набор скоро начнётся NCT07644273

Effects of a Multimodal and Multidimensional Intervention on Urinary Incontinence in Young Nulliparous Female Athletes.

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: Combined pelvic health education and lumbar-pelvic-abdominal stability strengthening programme., Usual activities.
Кому может быть актуально
Состояния в реестре: Urinary Incontinence. Базовые параметры: 15 лет — 40 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
Франция
Следующий шаг
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Официальное название

Effects of a Multimodal and Multidimensional Intervention on Urinary Incontinence in Young Nulliparous Female Athletes. Single-Center Randomized Controlled Stepped-Wedge Trial

Обзор

A prevalence of urinary incontinence ranging from 5.7% to 80% has been observed in young nulliparous athletes during their activity. The usual recommendations for managing adult women do not seem to be transferable. Young nulliparous athletes need specific educational and behavioral interventions and an alternative to pelvic floor muscle strengthening. A multimodal and multidimensional intervention for athletes and coaches combining specific pelvic health education and strengthening of lumbopelvic-abdominal stability appears to be an innovative and optimal solution for reducing the symptoms of urinary incontinence in young nulliparous women who participate in athletics.

Вмешательства

  • Другое Combined pelvic health education and lumbar-pelvic-abdominal stability strengthening programme.
    The intervention will consist of participants: i) reviewing educational content (8 educational videos online) ii) participating in two in-person sessions at the athletics club and performing lumbar-pelvic-abdominal stability exercises iii) learning and implementing recommendations for empowering themselves in pelvic health management. iv) complete reports in 6 questionnaires during follow-up.
  • Другое Usual activities
    Collection of data on routine activities

Первичные конечные точки

  • Urinary incontinence symptoms [Срок оценки: Week 1, 7, 13, 19, 25, 31]
Вторичные конечные точки (12)
  • The program's effects on the prevalence of urinary incontinence [Срок оценки: Week 1, 7, 13, 19, 25, 31]
  • Effects of the intervention on athletes' knowledge of the pelvic-perineal region [Срок оценки: Week 1, 31]
  • The program's effects on associated pelvic and perineal symptoms [Срок оценки: Week 1, 31]
  • The program's effects on urinary dysfunction. [Срок оценки: Week 1, 31]
  • Number of educational contents viewed [Срок оценки: Week 13, 19, 25]
  • Practicing lower back, pelvic, and abdominal stability exercises [Срок оценки: Week 1, 7, 13, 19, 25, 31]
  • The dose-response effect related to adherence [Срок оценки: Week 1, 7, 13, 19, 25, 31]
  • Program satisfaction [Срок оценки: Week 31]
  • Trends in Top Athletic Performance [Срок оценки: Week 1, 7, 13, 19, 25, 31]
  • Number of educational contents viewed by coaches [Срок оценки: Week 13, 19, 25]
  • Coaches' level of knowledge regarding the pelvic-perineal region [Срок оценки: Week 1, 31]
  • Practicing lumbar-pelvic-abdominal stability exercises [Срок оценки: Week 1, 7, 13, 19, 25, 31]

Критерии участия

Критерии включения

  • Female subject, nulliparous
  • Member of an athletics club affiliated with the French Athletics Federation (FFA)
  • At least 15 years old at the start of the study and belonging to the U16/U18/U20/U23 categories (born between January 1, 2005, and September 1, 2011)
  • Having internet access
  • Having access to a digital device (computer, tablet, mobile phone)
  • Affiliated with or covered by a social security scheme
  • Having freely given their express consent, as well as the express consent of both parents for minor participants

Критерии исключения

  • Any individual deprived of their liberty or subject to legal protection (guardianship, curatorship, or protective supervision).
  • A pregnant woman, a woman who has been pregnant, or a woman planning a pregnancy within the last nine months.
  • Any individual unable to understand the purpose and conditions of the study.
  • Any individual unable to give their consent.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Франция · 1 центр
  • CHU de Saint-Etienne — Saint-Etienne

Идентификаторы

NCT: NCT07644273 · 26CH163 · ANSM

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗