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Набор скоро начнётся NCT07661264

Effect of Different Pelvic Floor Loading Techniques on Women With Stress Urinary Incontinence

Без фазы С лечением Stress 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: Graduated loading positions, Graduated Vaginal Weights (Vaginal Cones).
Кому может быть актуально
Состояния в реестре: Stress Urinary Incontinence. Базовые параметры: 30 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
Египет
Следующий шаг
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Обзор

The purpose of this study is to compare the effects of different pelvic floor loading techniques (graduated positions versus graduated weights) on women with stress urinary incontinence.

Подробное описание

Stress incontinence results from an inability of the urethra to provide adequate resistance to the flow of urine with increased abdominal pressures. From a pathophysiologic perspective, stress incontinence may result from a lack of mechanical urethral support, resulting in urethral hypermobility and/or poor coaptation of the urethral tissues. Normally, forces that occur during the Valsalva maneuver are transmitted to the proximal urethra, resulting in compression of the urethra against the anterior vaginal wall; this process is disrupted in the setting of stress incontinence with urethral hypermobility.

The pelvic floor muscles (PFMs), including the levator ani muscle (LAMs), coccygeus, perineal muscles, striated urethral sphincter (SUS), and external anal sphincter, form the base of the abdomino-pelvic cavity and contribute to the support of the pelvic contents and continence control. The LAMs are considered a functional unit that provides support to the pelvic organs in the transverse plane (lifting) and compresses the urethra against the anterior vagina in the mid-sagittal plane (squeezing). Damage to or dysfunction of the LAMs is thought to be a contributor to stress urinary incontinence (SUI).

PFM-training, the most commonly used physical therapy treatment for women with SUI, is effective and therefore recommended as a first-line therapy.

According to traditional recommendations for PFM training programs, it is important to consider a gradual progression in the difficulty of the exercises, starting with less demanding positions (supine, standing, or side plank) and progressing to more complex challenges (quadruped hold, plank, and squat).

Vaginal Weights may be an effective training aid for women with mild to moderate stress incontinence, particularly in the absence of severe pelvic organ prolapse. They also may be useful for pelvic floor strengthening during the immediate postpartum period, as a behavioral program for continence maintenance, and for self-management programs.

Вмешательства

  • Другое Graduated loading positions
    The participants will be instructed to perform and repeat each exercise 10 times to build core muscle strength. They will then maintain the position comfortably for 1-5 minutes without engaging the pelvic floor muscles. Afterward, they will begin pelvic floor muscle exercises from each position, including quick flicks, slow contractions, and sustained contractions. The maintenance time will be gradually increased. Each position will be performed under both stable and unstable conditions: (i) S
  • Устройство Graduated Vaginal Weights (Vaginal Cones)
    The participants will perform pelvic floor exercises using graduated vaginal weights (cones). The vaginal cone is inserted into the vagina, and pelvic muscle contractions are used to hold it in place during a standing position. The procedure will begin with the lightest cone (white), in a position preferred by each patient. After inserting the vaginal cone, the pelvic muscles will contract for around 2 seconds to hold the cone in place. Initially, contractions of a few seconds will be repeated

Первичные конечные точки

  • Assessment of pelvic floor muscle strength [Срок оценки: 3 months]
Вторичные конечные точки (3)
  • Measurement of urethral angle (α) [Срок оценки: 3 months]
  • Assessment of stress urinary incontinence Severity [Срок оценки: 3 months]
  • Assessment of stress urinary incontinence Impact on Quality of Life [Срок оценки: 3 months]

Критерии участия

Критерии включения

  • All women are suffering from Stress urinary incontinence.
  • Their age will range from 30-40 years.
  • Their body mass index will range from 25-30 kg/m2.
  • They are multiparous women (2-3 times).

Критерии исключения

  • Patient with denervated pelvic floor muscle, urinary tract infection, severe prolapse of pelvic organs, fibroid uterus, or intrauterine devices.
  • Renal disease, pulmonary illness, chronic cough, and constipation.
  • Underwent surgery for stress urinary incontinence.
  • Other types of urinary incontinence (e.g., urge incontinence and mixed incontinence).
  • Diabetic patients.
  • Patient with anatomic changes (ectopic ureter, genito-urinary fistula)
  • Patient with knee or back symptoms (Osteoarthritis or lumbar disc).

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

Египет · 1 центр
  • Heba Allah Abdel salam Al-Bahrawy — Cairo

Идентификаторы

NCT: NCT07661264 · P.T.REC/012/006107

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗