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A Comparison of Home-Based Kegel Exercises Versus Clinic-Based Rehabilitation in Women With Urinary Incontinence in the Tabuk Region: A Randomized Controlled Trial (Incontinence)

26 de agosto de 2026 actualizado por: Enas Elsayed Mohamed Abutaleb, University of Tabuk

Background Urinary incontinence (UI) is a common condition among women that significantly affects physical health, emotional well-being, social participation, and overall quality of life. Pelvic floor muscle training (PFMT) is widely recommended as the first-line conservative treatment for urinary incontinence. While clinic-based rehabilitation provides direct supervision by healthcare professionals, home-based Kegel exercise programs offer greater convenience and accessibility. However, limited evidence exists regarding the comparative effectiveness of these approaches among women in Saudi Arabia.

Aim The study aims to compare the effectiveness of home-based Kegel exercises and clinic-based rehabilitation programs in improving pelvic floor muscle strength, reducing urinary incontinence symptoms, and enhancing quality of life among women with urinary incontinence in the Tabuk region.

Objectives

  1. To evaluate the effectiveness of home-based Kegel exercises in women with urinary incontinence.
  2. To evaluate the effectiveness of clinic-based pelvic floor rehabilitation.
  3. To compare outcomes between both intervention approaches.
  4. To compare the outcomes of both interventions regarding pelvic floor muscle strength, urinary leakage, and quality of life.
  5. To assess participants' adherence to the prescribed exercise programs. Methodology

This study will employ a randomized controlled trial (RCT) design. Eligible women diagnosed with urinary incontinence will be recruited from the Maternity and Children Hospital, Tabuk. Participants will be randomly assigned to one of two groups:

  • Group A: Home-based Kegel exercise program.
  • Group B: Supervised clinic-based pelvic floor rehabilitation program. Both interventions will be conducted over a 12-week period. Outcome Measures

The effectiveness of the interventions will be evaluated using:

  • Perineometer measurements to assess pelvic floor muscle strength.
  • Pad Test to assess urinary leakage severity.
  • King's Health Questionnaire (KHQ) to evaluate quality of life.
  • Adherence records to monitor compliance with the exercise program. Assessments will be conducted at baseline, week 8, and week 12. Data Analysis Data will be analyzed using SPSS software. Descriptive statistics, independent t-tests, Chi-square tests, and repeated-measures ANOVA will be used to compare outcomes between groups. Statistical significance will be set at p < 0.05.

Ethical Considerations Ethical approval will be obtained prior to study commencement. Written informed consent will be obtained from all participants. Participation will be voluntary, confidentiality will be maintained, and participants will have the right to withdraw from the study at any time without affecting their healthcare services.

Expected Outcomes The study is expected to demonstrate improvements in pelvic floor muscle strength, urinary continence, and quality of life in both groups. The findings will provide evidence regarding whether home-based Kegel exercises can achieve outcomes comparable to supervised clinic-based rehabilitation, thereby informing future physiotherapy practice and healthcare policy.

Significance This research will contribute to the growing body of evidence on pelvic floor rehabilitation and may support the implementation of accessible, cost-effective, and evidence-based treatment options for women with urinary incontinence in Tabuk region in Saudi Arabia. The results may also guide clinicians and healthcare decision-makers in optimizing rehabilitation services and improving patient outcomes.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

100

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

    • Tabuk Region
      • Tabuk, Tabuk Region, Arabia Saudita
        • Maternity and Children Hospital in Tabuk
        • Contacto:
          • Enas Elsayed Abutaleb, PhD
          • Número de teléfono: 0536346062
          • Correo electrónico: eabutaleb@ut.edu.sa

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:

  • Female participants aged 20-50 years.
  • Diagnosed with urinary incontinence.
  • Able to understand study instructions.
  • Willing to provide informed consent

Exclusion Criteria:

  • Delivery within the previous 3 months.
  • Gynecological surgery during the previous 3 months.
  • Lower urinary tract surgery during the previous 3 months.
  • Postmenopausal women.
  • Contraindications to pelvic floor muscle training.

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: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Home-Based Kegel Exercises
Women diagnosed with urinary incontinence in this arm attending the Women's Department of Maternity and Children Hospital will use an AI trainer called Kegel trainer for 12 weeks focusing on strengthening the pelvic floor muscles. They will join a telegram group supervised by the caregiver to follow their interactions during the whole period.
Kegel exercises are designed to focus on strengthening the weak pelvic floor muscles by using Kegel Trainer Application over 9 levels.
Otros nombres:
  • Kegel Trainer
  • Pelvic floor muscle exercises
Experimental: Clinic-Based Rehabilitation Program
Women diagnosed with urinary incontinence in this arm attending the Women's Department of Maternity and Children Hospital will be supervised by the Physiotherapist at the department for two times per week during the Kegel training for pelvic floor muscles training for 12 weeks .
Clinic-Based Rehabilitation Program will consist of physiotherapist supervised pelvic floor strengthening exercises for the participant , 2 times per week for 3 months

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Perineometer
Periodo de tiempo: From enrollment to the end of treatment at 12 weeks
Pelvic floor muscle strength will be measured using a perineometer
From enrollment to the end of treatment at 12 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
long-term Pad Test
Periodo de tiempo: From enrollment to the end of treatment at 12 weeks
Urinary leakage severity will be measured using the long-term Pad Test
From enrollment to the end of treatment at 12 weeks
King's Health Questionnaire
Periodo de tiempo: From enrollment to the end of treatment at 12 weeks
• Quality of life will be measured using the King's Health Questionnaire
From enrollment to the end of treatment at 12 weeks

Colaboradores e Investigadores

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

Patrocinador

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 (Estimado)

1 de agosto de 2026

Finalización primaria (Estimado)

31 de enero de 2027

Finalización del estudio (Estimado)

28 de febrero de 2027

Fechas de registro del estudio

Enviado por primera vez

26 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

26 de agosto de 2026

Publicado por primera vez (Actual)

31 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

31 de agosto de 2026

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

26 de agosto 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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