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

4 de junio de 2026 actualizado por: Riphah International University

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

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.

Descripción general del estudio

Estado

Reclutamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • Punjab Province
      • Sargodha, Punjab Province, Pakistán, 40100
        • Reclutamiento
        • Bilal Medicare, Sargodha
        • Investigador principal:
          • Khadeeja Cheema, MSWHPT

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Hafiza Iqra Rubab, MSWHPT, Riphah International University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de octubre de 2025

Finalización primaria (Estimado)

1 de julio de 2026

Finalización del estudio (Estimado)

1 de julio de 2026

Fechas de registro del estudio

Enviado por primera vez

1 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

4 de junio de 2026

Publicado por primera vez (Actual)

5 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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