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Effects of Pelvic Floor Rehab Protocol on Urinary Incontinence

17 de julio de 2026 actualizado por: Riphah International University

Effects of Pregnancy Specific Pelvic Floor Rehab Protocol on Urinary Incontinence

Urinary incontinence is a serious health issue that deeply affects a person's daily life and overall well-being. The global prevalence of UI is between 5 to 69% during a woman's lifetime, with higher prevalence in older age groups. The goal of this randomized controlled trial is to compare the effects of pregnancy specific pelvic floor rehab protocol with the standard protocol on urinary incontinence. Participants will be randomly assigned to one of the two groups. The results of this trial would be helpful in this way that how Pregnancy specific pelvic floor rehab protocol can provide support for pregnant ladies with urinary incontinence and improve health outcomes.

Descripción general del estudio

Descripción detallada

The International Continence Society defines urinary incontinence as the 'unintentional or involuntary leakage of urine'. Urinary incontinence is a serious health issue that deeply affects a person's daily life and overall well-being. It can be physically exhausting and emotionally overwhelming, often leading to embarrassment, loss of confidence, and feelings of helplessness. Many people dealing with it also struggle with anxiety and depression, as it limits their freedom and makes even simple daily tasks feel challenging. Urinary incontinence (UI) is common during pregnancy with prevalence rates of 31% in nulliparous women and 42% in parous women. The global prevalence of UI is between 5 to 69% during a woman's lifetime, with higher prevalence in older age groups. . Urinary incontinence during pregnancy affects women's physical comfort, emotional well-being, and quality of life, yet it remains under-identified and undertreated in standard antenatal care. Although pelvic floor exercises are widely recommended, most existing programs are not adapted to the unique demands of pregnancy. A structured, pregnancy-specific pelvic floor rehabilitation protocol can address these needs more effectively by offering trimester-based guidance, functional training, and education. . This pregnancy-specific pelvic floor rehabilitation protocol follows a progressive 4-week plan focused on pelvic floor muscle training, core activation, and functional strengthening. Exercises such as Kegels, abdominal drawing-in, bridging, and clamshells are performed in various positions with controlled breathing. Each 30-minute session, conducted twice weekly, includes a structured warm-up, weekly targeted exercises (Week 1-4), and a cool-down phase for relaxation, flexibility, and bladder/postural education. Participants will be randomly assigned through convenient sampling method to each groups. Ethical considerations will be completely taken and data will be analyzed through SPSS version 26. This study aims to evaluate the impact of such a protocol and provide evidence to support its integration into routine prenatal care, potentially improving maternal outcomes and long-term recovery.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

48

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.

Ubicaciones de estudio

    • Islamabad
      • Islamabad, Islamabad, Pakistán, 44000
        • Riphah International Hospital

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:

  • Pregnant women aged 18-35 yrs.
  • Score ≥1 on stress or urge subscale of the Questionnaire for Incontinence Diagnosis
  • No participation in a structured pelvic floor rehabilitation program within the last six months.

Exclusion Criteria:

  • • Patients with High-risk pregnancy.

    • Known neurological disorders.
    • History of pelvic surgery.
    • ACOG Contraindications for Exercise

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: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Standard Pelvic floor Rehab Protocol Group
This group receives standard protocol for strengthening of pelvic floor to prevent urinary incontinence.
in this group, standard exercises used for strengthening of pelvic floor to prevent urinary incontinence will be implemented.
Experimental: Pregnancy Specific Pelvic floor Rehab Protocol (PSPFR) Group (2nd Trimester)
This group will receive a pregnancy-specific supervised pelvic floor rehabilitation protocol and basic antenatal education. There will be 2 sessions per week for 4 weeks. Each 30-minute session, conducted twice weekly, includes a structured warm-up, weekly targeted exercises (Week 1-4), and a cool-down phase for relaxation, flexibility, and bladder/postural education.
This pregnancy-specific pelvic floor rehabilitation protocol follows a progressive 4-week plan focused on pelvic floor muscle training, core activation, and functional strengthening. Exercises such as Kegels, abdominal drawing-in, bridging, and clamshells are performed in various positions with controlled breathing. Each 30-minute session, conducted twice weekly, includes a structured warm-up, weekly targeted exercises (Week 1-4), and a cool-down phase for relaxation, flexibility, and bladder/postural education. The instructions of the supervised exercises would be Hold for 2 s in 3 repetitions, 5 seconds rest, 1 minute of rest between each exercise & 2 sets each. The record of each session will be written in diaries.
Experimental: Pregnancy Specific Pelvic floor Rehab Protocol (PSPFR) Group (3rd Trimester)
This group will receive a pregnancy-specific supervised pelvic floor rehabilitation protocol and basic antenatal education. There will be 2 sessions per week for 4 weeks. Each 30-minute session, conducted twice weekly, includes a structured warm-up, weekly targeted exercises (Week 1-4), and a cool-down phase for relaxation, flexibility, and bladder/postural education.
This pregnancy-specific pelvic floor rehabilitation protocol follows a progressive 4-week plan focused on pelvic floor muscle training, core activation, and functional strengthening. Exercises such as Kegels, abdominal drawing-in, bridging, and clamshells are performed in various positions with controlled breathing. Each 30-minute session, conducted twice weekly, includes a structured warm-up, weekly targeted exercises (Week 1-4), and a cool-down phase for relaxation, flexibility, and bladder/postural education. The instructions of the supervised exercises would be Hold for 2 s in 3 repetitions, 5 seconds rest, 1 minute of rest between each exercise & 2 sets each. The record of each session will be written in diaries.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Questionnaire for Incontinence Diagnosis
Periodo de tiempo: 4 weeks
The Questionnaire for Incontinence Diagnosis is a self-reported screening tool used to identify the presence and type of urinary incontinence, such as stress, urge, or mixed incontinence. It consists of structured questions related to symptom triggers, frequency, and leakage patterns. Each item scores 0 (None of the time), 1 (Rarely), 2 (Once in a while), 3 (Often), 4 (Most of the time) or 5 (All of the time). Responses to items 1, 2 and 3 are summed for the Stress score; and responses to items 4, 5, and 6 are summed for the Urge score.
4 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incontinence Severity Index
Periodo de tiempo: 4 weeks
The ISI is a quick, two-question tool that assesses the frequency and amount of urine leakage. Scores range from 0 to 12, indicating severity from none to very severe. It is simple to administer and useful for tracking symptom changes over time.
4 weeks
International Consultation on Incontinence Questionnaire (ICIQ-UI-SF)
Periodo de tiempo: 4 weeks
The ICIQ-UI-SF is a validated self-reported questionnaire that assesses the frequency, severity, and impact of urinary incontinence. Scores range from 0 to 21, with higher scores indicating greater symptom severity and quality-of-life impact. It is widely used to quantify the patient-reported burden of incontinence.
4 weeks
Incontinence Impact Questionnaire
Periodo de tiempo: 4 weeks
The IIQ-7 assesses the psychosocial and functional impact of urinary incontinence on daily life, including physical activity, travel, and emotional well-being. Scores range from 0 to 100, with higher scores reflecting a greater negative impact. It is a useful tool for evaluating quality of life related to incontinence.
4 weeks
Patient Global Impression of Improvement Scale
Periodo de tiempo: 4 weeks
The PGI-I is a single-item scale that captures the patient's overall perception of symptom improvement after treatment. It reflects subjective satisfaction with the intervention. The 7-point scale ranges from 1 (very much better) to 7 (very much worse), with lower scores indicating greater improvement.
4 weeks

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Dr Zahra Ijaz, 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 noviembre de 2025

Finalización primaria (Actual)

7 de mayo de 2026

Finalización del estudio (Estimado)

30 de julio de 2026

Fechas de registro del estudio

Enviado por primera vez

18 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

18 de mayo de 2026

Publicado por primera vez (Actual)

22 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de julio de 2026

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

17 de julio de 2026

Última verificación

1 de julio 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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