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Идёт набор NCT07337278

Posturography Rehabilitation and Pelvic Floor Training on Urinary Incontinence in Women

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: Pelvic Floor Muscle Training, Posturography Rehabilitation.
Кому может быть актуально
Состояния в реестре: Urinary Incontinence. Базовые параметры: 18 лет — 65 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
Morocco
Следующий шаг
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Официальное название

Effect of Lumbopelvic Rehabilitation Using Posturography Combined With Pelvic Floor Training on Urinary Incontinence in Women

Обзор

The goal of this clinical trial is to evaluate whether lumbopelvic postural rehabilitation combined with pelvic floor muscle training (PFMT) is more effective than PFMT alone in women with urinary incontinence. The main questions it aims to answer are: * Does the addition of lumbopelvic postural rehabilitation improve the severity of urinary incontinence as measured by the ICIQ-UI-SF questionnaire? * Does it improve urinary symptom profile, pelvic floor muscle strength, patient-reported overall improvement, and quality of life compared to PFMT alone? Participants will be randomly assigned to one of two groups: * Experimental group (Group A): PFMT (3 sessions/week) plus lumbopelvic postural rehabilitation (2 sessions/week) for 12 weeks. * Control group (Group B): PFMT alone (3 sessions/week) for 12 weeks. Participants will perform pelvic floor exercises in supine and seated positions, with supervised sessions at the hospital and home exercises. Postural rehabilitation includes stability and mobility exercises for the lumbopelvic region using Posturography. Outcomes will be assessed at baseline, at 6 weeks, and at 12 weeks.

Вмешательства

  • Поведенческое Pelvic Floor Muscle Training
    Pelvic floor training consists of voluntary contractions of the pelvic floor muscles, using short, rapid contractions combined with slow, sustained contractions, aimed at improving strength and endurance. Training is performed in supine and seated positions, with one supervised session per week at the hospital and three home sessions per week, over a total duration of 12 weeks.
  • Поведенческое Posturography Rehabilitation
    Postural rehabilitation consists of seated exercises focusing on stability and mobility of the lumbopelvic region, using posturography. Sessions last 30 minutes, conducted twice weekly, over a total duration of 12 weeks.

Первичные конечные точки

  • International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) [Срок оценки: 6 weeks and 12 weeks from start of intervention]
Вторичные конечные точки (4)
  • Patient Global Impression of Improvement (PGI-I) [Срок оценки: 6 weeks and 12 weeks from start of intervention]
  • Urinary Symptom Profile (USP) scores [Срок оценки: 6 weeks and 12 weeks from start of intervention]
  • Pelvic Floor Muscle Strength (Modified Oxford Scale) [Срок оценки: 6 weeks and 12 weeks from start of intervention]
  • Incontinence Impact Questionnaire - Short Form (IIQ-7) [Срок оценки: 6 weeks and 12 weeks from start of intervention]

Критерии участия

Критерии включения

  • Female participants aged between 18 and 65 years
  • Presence of clinical signs of urinary incontinence (stress urinary incontinence and/or urge urinary incontinence and/or mixed urinary incontinence) diagnosed according to the International Continence Society (ICS) terminology
  • USP (urinary symptom profile) scores for stress urinary incontinence and/or overactive bladder ≥ 1
  • Normal neuro-perineal examination
  • Written informed consent provided prior to participation in the study

Критерии исключения

  • Known detrusor overactivity or reduced bladder compliance of neurological origin
  • Associated voiding dysfunction, defined as a Urinary Symptom Profile (USP) dysuria subscale score ≥ 1
  • Known organic or morphological pathology of the lower urinary tract
  • Pelvic organ prolapse grade II or higher according to the Pelvic Organ Prolapse Quantification system (POP-Q)
  • Current urinary tract infection or vaginal infection
  • Cognitive or visual impairments that may interfere with understanding or performing the exercise program
  • Pregnant women or women within 10 months postpartum
  • Anticholinergic medication use or hormone replacement therapy within the last 6 months
  • Recent pelvic or abdominal surgery within the last 6 months

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

Morocco · 1 центр
  • Al Ayachi Hospital, CHU Ibn Sina — Rabat

Идентификаторы

NCT: NCT07337278 · UM5-MPR-2025-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗