- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07628322
Comparative Effects of Hypopressive Exercises and Paula Method in Postpartum Women.
Comparative Effects of Hypopressive Exercises and Paula Method on Urinary Incontinence, Pelvic Floor Muscle Strength and Quality of Life in Postpartum Women
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Imran Amjad, PhD
- Número de telefone: 03324390125
- E-mail: imran.amjad@riphah.edu.pk
Locais de estudo
-
-
Punjab Province
-
Sargodha, Punjab Province, Paquistão, 40100
- Recrutamento
- Bilal Medicare, Sargodha
-
Investigador principal:
- Khadeeja Cheema, MSWHPT
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
• 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)
Exclusion Criteria:
• 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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Hypopressive exercise
Group A will be given Hypopressive exercise
|
(n=30) Each participant will receive treatment with hypopressive exercises for entire 08 weeks' intervention period.
|
|
Experimental: Paula exercise
Group B will be given Paula exercise protocol.
|
Each participant will receive treatment with the Paula method for entire 08 weeks' intervention period.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
Prazo: 8 weeks
|
The ICIQ-UI SF is a standardized and internationally recognized tool for assessing the severity of urinary incontinence and its impact on quality of life.
It consists of 4 questions; frequency of leakage, amount of urine lost, overall impact on daily life and self-diagnostic items (non-scored).
|
8 weeks
|
|
Modified Oxford Grading Scale (Manual Muscle Testing of Pelvic Floor)
Prazo: 8 weeks
|
This clinical scale is used to assess pelvic floor muscle strength through vaginal palpation, grading the strength from 0 (no contraction) to 5 (strong contraction).
It helps determine the baseline function and progress of pelvic floor rehabilitation.
The scale uses a single-item score ranging from 0 to 5, based on the therapist's tactile evaluation of the pelvic floor contraction.
Though subjective, its validity is supported through clinical correlation with manometric and EMG readings.
It is especially useful in low-resource settings where instrumentation is unavailable.
|
8 weeks
|
|
Urinary Incontinence Impact Questionnaire - 7 (UIQ-7)
Prazo: 8 weeks
|
The UIQ-7 is a subscale of the PFIQ-7 and is used to evaluate the impact of urinary incontinence on daily activities and social functioning.
It is especially useful for measuring the subjective burden of incontinence on the patient's life.
The UIQ-7 consists of 7 questions, each scored on a scale of 0 (not at all) to 3 (quite a bit), with a total score ranging from 0 to 21.
Higher scores indicate greater impact on quality of life.
|
8 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hafiza Iqra Rubab, MSWHPT, Riphah International University
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Urogenitais Masculinas
- Doenças Urológicas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Distúrbios da micção
- Sintomas do Trato Urinário Inferior
- Manifestações Urológicas
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Incontinencia urinaria
Outros números de identificação do estudo
- REC/PCR & AHS/25/0513
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .