The Effect of Blood Flow Restriction Training on Postmenopausal Stress Urinary Incontinence

Обзор

the purpose of the study is to investigate the effect of blood flow restriction training on postmenopausal SUI.

Подробное описание

We have two groups: control group (A) and experimental group (B) are two matched post-menopausal stress urinary incontinence. Group A will receive PFMT-associated EMG biofeedback, whereas Group B will receive PFMT-associated EMG biofeedback while applying blood flow restriction to the proximal thigh. Our primary outcome measures will be the severity of SUI symptoms, while the secondary outcome measures will involve QOL, self-esteem, patient's global impression of improvement, maximum voluntary isometric contraction (MVIC) of pelvic floor muscles, pelvic floor muscle resting tone, and the endurance of pelvic floor muscles,

Вмешательства

• Другое pelvic floor muscle training -associated EMG-biofeedback.
  The control group will receive pelvic floor muscle training-associated EMG biofeedback for 10 weeks
• Другое blood flow restriction
  experimental group will receive Pelvic floor muscle training-associated EMG biofeedback while applying blood flow restriction to the proximal thigh for 10 weeks.

Первичные конечные точки

• severity of stress urinary incontinence (SUI) symptoms. [Срок оценки: baseline,10 weeks, 16 weeks]

Вторичные конечные точки (6)

• Quality of life (QOL) [Срок оценки: baseline,10 weeks, 16 weeks]
• self-esteem [Срок оценки: baseline,10 weeks, 16 weeks]
• patient's global impression of improvement [Срок оценки: baseline,10 weeks, 16 weeks]
• maximum voluntary isometric contraction (MVIC) of pelvic floor muscles [Срок оценки: baseline,10 weeks, 16 weeks]
• pelvic floor muscle resting tone [Срок оценки: baseline,10 weeks, 16 weeks]
• pelvic floor muscle endurance [Срок оценки: baseline,10 weeks, 16 weeks]

Критерии участия

Критерии включения

• post-menopausal women, defined by the absence of vaginal bleeding for 12 months,
• body mass index (BMI) < 30
• They should have faced at least two leakage episodes each week and fall into the mild to moderate range of urinary incontinence, measured by (ICIQ-UI SF).
• Two standard questions about stress and urgency UI were used to determine the patient's eligibility.

Критерии исключения

• pelvic organ prolapse greater than grade II on Baden-Walker classification system
• previous treatment for UI or hormone therapy, ongoing urinary tract infections, cognitive or neurological disorder, or inability to perform the proposed procedures.
• anyone with past or current injuries to the pelvis, hip joint, or spine, as well as those with uncontrolled diabetes, or those with prior experience in pelvic floor muscle training .
• the presence of uncontrolled hypertension.
• patients with a history of deep venous thrombosis (DVT), varicose Veins, cardiac disease, or lymphedema.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07322250 · KFSIRB200-800

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗