Tactile Feedback Pelvic Floor Training to Prevent Stress Urinary Incontinence in the 3rd Trimester of Pregnancy
2026년 8월 17일 업데이트: 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).
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
141
단계
- 해당 없음
연락처 및 위치
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연구 장소
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Banqiao Dist
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New Taipei City, Banqiao Dist, 대만
- Far Eastern Memorial Hospital
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참여기준
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자격 기준
공부할 수 있는 나이
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건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 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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활성 비교기: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Urinary Symptoms (Bladder Diary)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Duration of Second Stage of Labor
기간: 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)
기간: 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
기간: 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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연구 주요 날짜
연구 시작 (실제)
2023년 3월 8일
기본 완료 (실제)
2025년 5월 5일
연구 완료 (실제)
2025년 5월 5일
연구 등록 날짜
최초 제출
2025년 5월 27일
QC 기준을 충족하는 최초 제출
2026년 6월 19일
처음 게시됨 (실제)
2026년 6월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 17일
마지막으로 확인됨
2026년 6월 1일
추가 정보
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기타 연구 ID 번호
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