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Идёт набор NCT07628322

Comparative Effects of Hypopressive Exercises and Paula Method in Postpartum Women.

Без фазы С лечением Urinary Incontinence (UI)

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: Hypopressive exercise, Paula exercise.
Кому может быть актуально
Состояния в реестре: Urinary Incontinence (UI). Базовые параметры: 25 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
Пакистан
Следующий шаг
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Официальное название

Comparative Effects of Hypopressive Exercises and Paula Method on Urinary Incontinence, Pelvic Floor Muscle Strength and Quality of Life in Postpartum Women

Обзор

This study will be a randomized clinical trial with a sample size of 60 postpartum females. The setting of the study will be Bilal Medicare, Sargodha. 60 postpartum women will be included based on age, parity, mode of delivery and type of urinary incontinence. Women with primary gravida, cesarean section and urge and mixed urinary incontinence will be excluded. This study aims to compare the effectiveness of Hypopressive Exercises and the Paula Method in improving urinary incontinence severity, pelvic floor muscle strength and quality of life in postpartum women. Patients of both groups receive two treatment sessions per week over an 8-week period. Group A will be given Hypopressive exercise and Group B will be given Paula exercise protocol. Both groups will perform a standardized kegel exercises for pelvic floor muscle activation and strengthening as baseline treatment followed by their assigned interventions.

Подробное описание

Stress urinary incontinence (SUI) is a prevalent pelvic floor disorder among postpartum women specially with multi-parity, significantly affecting their physical, psychological, and social well-being. Repeated vaginal deliveries can lead to pelvic floor muscle weakness, reduced support to pelvic organs, and impaired urinary control. Many non-invasive physical therapy strategies have gained popularity, particularly among women unable to effectively contract their pelvic floor muscles voluntarily. Two such techniques are Hypopressive Exercises and the Paula Method. Hypopressive exercises involve specific breathing patterns combined with postural adjustments that activate the pelvic floor through reflex mechanisms. In contrast, the Paula Method is based on the concept of muscular synergy among circular muscles. It utilizes rhythmic contractions of peripheral circular muscles (such as the eyes, lips, and sphincters) to stimulate the pelvic floor, making it especially beneficial for individuals with coordination issues or discomfort performing direct pelvic contractions.

This study will be a randomized clinical trial with a sample size of 60 postpartum females. The setting of the study will be Bilal Medicare, Sargodha. 60 postpartum women will be included based on age, parity, mode of delivery and type of urinary incontinence. Women with primary gravida, cesarean section and urge and mixed urinary incontinence will be excluded. This study aims to compare the effectiveness of Hypopressive Exercises and the Paula Method in improving urinary incontinence severity, pelvic floor muscle strength and quality of life in postpartum women. Patients of both groups receive two treatment sessions per week over an 8-week period. Group A will be given Hypopressive exercise and Group B will be given Paula exercise protocol. Both groups will perform a standardized kegel exercises for pelvic floor muscle activation and strengthening as baseline treatment followed by their assigned interventions. Outcome measures will include the International Consultation on Incontinence Questionnaire (ICIQ-UI SF), Modified Oxford Scale for muscle strength, and Incontinence Impact Questionnaire (IIQ-7) for QoL assessment. Data will be statistically analyzed using SPSS version 25.

Вмешательства

  • Другое Hypopressive exercise
    (n=30) Each participant will receive treatment with hypopressive exercises for entire 08 weeks' intervention period.
  • Другое Paula exercise
    Each participant will receive treatment with the Paula method for entire 08 weeks' intervention period.

Первичные конечные точки

  • International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) [Срок оценки: 8 weeks]
  • Modified Oxford Grading Scale (Manual Muscle Testing of Pelvic Floor) [Срок оценки: 8 weeks]
  • Urinary Incontinence Impact Questionnaire - 7 (UIQ-7) [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

  • • Multipara women from 25-40 years
  • Six weeks postpartum
  • Vaginal delivery method
  • Reported ≥1 episodes of urine leakage per week
  • Diagnosed with SUI (ICIQ-UI SF ≥6)

Критерии исключения

  • • No pelvic floor physiotherapy in last 6 months
  • Patients with any medical and gynaecological risk factors and /or conditions
  • Patients with any neurological problems, urinary tract infection, diabetes mellitus, hepatitis and ascites
  • Pelvic surgery in last 6 months
  • Mental or cognitive impairment

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

Пакистан · 1 центр
  • Bilal Medicare, Sargodha — Sargodha

Публикации

  • Li C, Li K. Effect of pelvic floor muscle exercise combined with infrared physiotherapy on postpartum urinary incontinence. Technol Health Care. 2025;33(1):225-234. doi: 10.3233/THC-240831. PMID 39302396
  • Sherif Mohamed MM, Hanafy HM, Awad MA, Samir SH. Effect of Hip Strengthening Exercises and Pelvic Floor Exercises on Stress Urinary Incontinence in Postnatal Women. Frontiers in Health Informatics. 2024;13(3).
  • Mahmoud NSA. Effect of hypopressive exercises versus pelvic floor muscle exercises on stress urinary incontinence among multiparous women. Assiut Scientific Nursing Journal. 2023;11(40):162-74.
  • Zhong R, Zeng L, Wang X, Wang Y. A retrospective study of risk factors for stress urinary incontinence 1 year after delivery in multiparous women. Int Urogynecol J. 2022 Aug;33(8):2275-2281. doi: 10.1007/s00192-021-04802-1. Epub 2021 May 4. PMID 33944979
  • Katz CMS, Barbosa CP. Effects of hypopressive exercises on pelvic floor and abdominal muscles in adult women: A systematic review of randomized clinical trials. J Bodyw Mov Ther. 2024 Jan;37:38-45. doi: 10.1016/j.jbmt.2023.03.003. Epub 2023 Aug 24. PMID 38432833

Идентификаторы

NCT: NCT07628322 · REC/PCR & AHS/25/0513

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗