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

2026年8月17日 更新者：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).

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

141

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 台湾
    • Banqiao Dist
      • New Taipei City、Banqiao Dist、台湾
        • Far Eastern Memorial Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：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.
行为的：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.
有源比较器：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.
行为的：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.
实验性的：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.
行为的：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Urinary Symptoms (Bladder Diary)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Duration of Second Stage of Labor
大体时间：At delivery
Duration of the second stage of labor obtained from medical records.
At delivery
The Pittsburgh Sleep Quality Index (PSQI)
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Far Eastern Memorial Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年3月8日

初级完成 (实际的)

2025年5月5日

研究完成 (实际的)

2025年5月5日

研究注册日期

首次提交

2025年5月27日

首先提交符合 QC 标准的

2026年6月19日

首次发布 (实际的)

2026年6月25日

研究记录更新

最后更新发布 (实际的)

2026年8月19日

上次提交的符合 QC 标准的更新

2026年8月17日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 111302-F

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Based on personal data privacy

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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