Tactile Feedback Pelvic Floor Training to Prevent Stress Urinary Incontinence in the 3rd Trimester of Pregnancy
17 de agosto de 2026 actualizado por: Ya-Wel Chu, Far Eastern Memorial Hospital
Tactile Feedback on Pelvic Floor Muscle Training in the 3rd Trimester of Pregnancy to Prevent of Stress Urinary Incontinence and Its Influence on Biological and Psychological Symptoms
Pregnancy involves significant physiological changes, such as hormone fluctuations, weight gain, and fetal growth, which can affect multiple organ systems. These changes often lead to symptoms like stress urinary incontinence (SUI) and may worsen existing conditions. SUI affects about one-third of pregnant women and can decrease quality of life.
Pelvic floor muscle exercise (PFME) is a recommended treatment to manage urinary incontinence during pregnancy and postpartum. This study aims to compare the effectiveness of three interventions: routine health education, traditional PFME, and tactile feedback PFME, on reducing SUI symptoms, shortening the second stage of labor, and improving quality of life.
Participants will be enrolled in their third trimester and randomly assigned to one of the three groups, with each intervention lasting 8 weeks. Outcome measures include urinary symptoms (via bladder diary, UDI-6, and IIQ-7), quality of life (via KHQ and WHOQOL-BREF), and labor outcomes (duration of the second stage).
Descripción general del estudio
Estado
Terminado
Descripción detallada
This study compares the effectiveness of three interventions-routine health education, traditional pelvic floor muscle exercise (PFME), and tactile feedback PFME-in improving urinary incontinence in pregnant women.
Participants will receive one of these interventions over 8 weeks during the third trimester.
The primary outcome measures include changes in urinary incontinence symptoms, quality of life,and the duration of the second stage of labor.
Participants will be evaluated at baseline and 8 weeks post-intervention.
This study also aims to determine whether tactile feedback PFME is more effective than traditional PFME or routine health education in reducing urinary incontinence symptoms and improving labor outcomes.
Tipo de estudio
Intervencionista
Inscripción (Actual)
141
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
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Banqiao Dist
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New Taipei City, Banqiao Dist, Taiwán
- Far Eastern Memorial Hospital
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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 diagnosed with urinary incontinence by obstetricians or gynecologists during prenatal care.
- Women aged 20 years or older.
- Pregnant at 29 weeks of gestation.
- Singleton pregnancy with cephalic presentation.
- Anticipated vaginal delivery.
- Able to communicate and complete questionnaires without difficulty.
- Willing to participate and provide informed consent.
Exclusion Criteria:
- Diagnosed with high-risk pregnancy or at risk of preterm labor.
- Visual impairment or physical disability that limits participation.
- Currently taking medication for urinary incontinence during pregnancy.
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: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: Basic Health Education Group
Participants in this group receive a one-time, written health education leaflet, without any physical or in-person instruction.
The leaflet includes information on the occurrence and causes of urinary incontinence during pregnancy, dietary recommendations, weight management, and illustrated instructions for Kegel exercises.
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One-way, one-time health education leaflets are provided for written teaching, with only explanations but no physical teaching.
The content of the health education leaflets includes urinary incontinence during pregnancy, its causes, daily diet, weight control, and Kegel exercise execution methods and movements.
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Comparador activo: Kegel Exercise Group
Participants in this group receive four in-person sessions of conventional pelvic floor muscle training (PFMT) over an 8-week period.
The training is delivered through interactive, hands-on teaching methods, incorporating posture positioning, guided breathing techniques, and imagery-based instructions (e.g., "closing the door," squeezing the buttocks) to enhance awareness and execution of Kegel contractions.
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"Four in-person traditional pelvic floor muscle training sessions are scheduled over an eight-week period.
The training involves interactive, hands-on teaching that incorporates body positioning, guided breathing, and the 'closing and opening gate' theory.
This includes imagery techniques such as buttock squeezing and simulating the action of stopping urine flow to facilitate pelvic floor muscle contractions.
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Experimental: Sensorimotor-Enhanced PFMT
This group receives sensorimotor-enhanced pelvic floor muscle training (PFMT) in four in-person sessions over an 8-week period.
The training incorporates interactive instruction with body positioning, guided deep breathing, and finger-based tactile feedback.
Participants are guided to sense the lift and contraction of their pelvic floor muscles through palpation techniques, aiming to enhance muscle awareness and neuromuscular coordination.
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There are four physical tactile pelvic floor muscle training courses arranged in eight weeks.
The training process adopts two-way interactive practical teaching, using movement positioning and deep breathing to induce adjustment of the upper and lower strength of the pelvic floor, and using finger tactile feedback to feel the muscles lifting and contracting up and down during training.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Urinary Symptoms (Bladder Diary)
Periodo de tiempo: Baseline, 4 weeks, and 8 weeks post-intervention
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Mean number of normal voiding episodes per day, urinary incontinence episodes per day, urinary urgency episodes per day, and mean daily fluid intake recorded using a 3-day bladder diary.
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Baseline, 4 weeks, and 8 weeks post-intervention
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Urinary Symptom Distress (UDI-6)
Periodo de tiempo: Baseline, 4 weeks, and 8 weeks post-intervention
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Total score measured using the Urinary Distress Inventory-6 (UDI-6).
Scores range from 0 to 100, with higher scores indicating greater urinary symptom distress.
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Baseline, 4 weeks, and 8 weeks post-intervention
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Incontinence Impact on Daily Life (IIQ-7)
Periodo de tiempo: Baseline, 4 weeks, and 8 weeks post-intervention
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Total score measured using the Incontinence Impact Questionnaire-7 (IIQ-7).
Scores range from 0 to 100, with higher scores indicating greater impact of urinary incontinence on daily activities.
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Baseline, 4 weeks, and 8 weeks post-intervention
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Urinary Incontinence-Related Quality of Life (KHQ)
Periodo de tiempo: Baseline, 4 weeks, and 8 weeks post-intervention
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Domain scores measured using the King's Health Questionnaire (KHQ), including General Health Perception, Role Limitation, Physical Limitation, Social Limitation, Personal Relationships, Emotions, Sleep/Energy, and Severity Measures.
Scores range from 0 to 100, with higher scores indicating poorer quality of life.
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Baseline, 4 weeks, and 8 weeks post-intervention
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Global Quality of Life (WHOQOL-BREF Taiwan Version)
Periodo de tiempo: Baseline, 4 weeks, and 8 weeks post-intervention
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Total score measured using the WHOQOL-BREF Taiwan Version.
Higher scores indicate better quality of life.
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Baseline, 4 weeks, and 8 weeks post-intervention
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International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form(ICIQ-UI-SF)
Periodo de tiempo: Baseline, 4 weeks, and 8 weeks post-intervention
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Scores range from 0 to 21, with higher scores indicating greater urinary symptom severity.
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Baseline, 4 weeks, and 8 weeks post-intervention
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Brief Pain Inventory(BPI)
Periodo de tiempo: Baseline, 4 weeks, and 8 weeks post-intervention
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Scores range from 0 to 10, with higher scores indicating greater pain severity or greater interference with daily activities.
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Baseline, 4 weeks, and 8 weeks post-intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Duration of Second Stage of Labor
Periodo de tiempo: At delivery
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Duration of the second stage of labor obtained from medical records.
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At delivery
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The Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: Baseline, 4 weeks, and 8 weeks post-intervention
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Scores range from 0 to 21, with higher scores indicating poorer sleep quality.
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Baseline, 4 weeks, and 8 weeks post-intervention
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Pelvic Floor Muscle Exercise Self-Efficacy Scale
Periodo de tiempo: Baseline, 4 weeks, and 8 weeks post-intervention
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Scores range from 17 to 85, with higher scores indicating greater self-efficacy for performing pelvic floor muscle exercises.
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Baseline, 4 weeks, and 8 weeks post-intervention
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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 (Actual)
8 de marzo de 2023
Finalización primaria (Actual)
5 de mayo de 2025
Finalización del estudio (Actual)
5 de mayo de 2025
Fechas de registro del estudio
Enviado por primera vez
27 de mayo de 2025
Primero enviado que cumplió con los criterios de control de calidad
19 de junio de 2026
Publicado por primera vez (Actual)
25 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de agosto de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades urogenitales masculinas
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Trastornos de la micción
- Síntomas del tracto urinario inferior
- Manifestaciones Urológicas
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Incontinencia urinaria
- Incontinencia Urinaria, Estrés
Otros números de identificación del estudio
- 111302-F
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Based on personal data privacy
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
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