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Tactile Feedback Pelvic Floor Training to Prevent Stress Urinary Incontinence in the 3rd Trimester of Pregnancy

17 de agosto de 2026 atualizado 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).

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Real)

141

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Taiwan
    • Banqiao Dist
      • New Taipei City, Banqiao Dist, Taiwan
        • Far Eastern Memorial Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: 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.
Comportamental: Basic Health Education Group
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.
Comparador Ativo: 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.
Comportamental: Pelvic floor muscle training
"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.
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.
Comportamental: Tactile pelvic floor muscle training group
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Urinary Symptoms (Bladder Diary)
Prazo: Baseline, 4 weeks, and 8 weeks post-intervention
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.
Baseline, 4 weeks, and 8 weeks post-intervention
Urinary Symptom Distress (UDI-6)
Prazo: Baseline, 4 weeks, and 8 weeks post-intervention
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.
Baseline, 4 weeks, and 8 weeks post-intervention
Incontinence Impact on Daily Life (IIQ-7)
Prazo: Baseline, 4 weeks, and 8 weeks post-intervention
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.
Baseline, 4 weeks, and 8 weeks post-intervention
Urinary Incontinence-Related Quality of Life (KHQ)
Prazo: Baseline, 4 weeks, and 8 weeks post-intervention
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.
Baseline, 4 weeks, and 8 weeks post-intervention
Global Quality of Life (WHOQOL-BREF Taiwan Version)
Prazo: Baseline, 4 weeks, and 8 weeks post-intervention
Total score measured using the WHOQOL-BREF Taiwan Version. Higher scores indicate better quality of life.
Baseline, 4 weeks, and 8 weeks post-intervention
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form(ICIQ-UI-SF)
Prazo: Baseline, 4 weeks, and 8 weeks post-intervention
Scores range from 0 to 21, with higher scores indicating greater urinary symptom severity.
Baseline, 4 weeks, and 8 weeks post-intervention
Brief Pain Inventory(BPI)
Prazo: Baseline, 4 weeks, and 8 weeks post-intervention
Scores range from 0 to 10, with higher scores indicating greater pain severity or greater interference with daily activities.
Baseline, 4 weeks, and 8 weeks post-intervention

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Duration of Second Stage of Labor
Prazo: At delivery
Duration of the second stage of labor obtained from medical records.
At delivery
The Pittsburgh Sleep Quality Index (PSQI)
Prazo: Baseline, 4 weeks, and 8 weeks post-intervention
Scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Baseline, 4 weeks, and 8 weeks post-intervention
Pelvic Floor Muscle Exercise Self-Efficacy Scale
Prazo: Baseline, 4 weeks, and 8 weeks post-intervention
Scores range from 17 to 85, with higher scores indicating greater self-efficacy for performing pelvic floor muscle exercises.
Baseline, 4 weeks, and 8 weeks post-intervention

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Far Eastern Memorial Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

8 de março de 2023

Conclusão Primária (Real)

5 de maio de 2025

Conclusão do estudo (Real)

5 de maio de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

27 de maio de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de junho de 2026

Primeira postagem (Real)

25 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

19 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de agosto de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 111302-F

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Based on personal data privacy

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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