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).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
141
"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.
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.
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.
Far Eastern Memorial Hospital
New Taipei City, Banqiao Dist, Taiwan
Urinary Symptoms (Bladder Diary)
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.
Time frame: Baseline, 4 weeks, and 8 weeks post-intervention
Urinary Symptom Distress (UDI-6)
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.
Time frame: Baseline, 4 weeks, and 8 weeks post-intervention
Incontinence Impact on Daily Life (IIQ-7)
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.
Time frame: Baseline, 4 weeks, and 8 weeks post-intervention
Urinary Incontinence-Related Quality of Life (KHQ)
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.
Time frame: Baseline, 4 weeks, and 8 weeks post-intervention
Global Quality of Life (WHOQOL-BREF Taiwan Version)
Total score measured using the WHOQOL-BREF Taiwan Version. Higher scores indicate better quality of life.
Time frame: Baseline, 4 weeks, and 8 weeks post-intervention
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form(ICIQ-UI-SF)
Scores range from 0 to 21, with higher scores indicating greater urinary symptom severity.
Time frame: Baseline, 4 weeks, and 8 weeks post-intervention
Brief Pain Inventory(BPI)
Scores range from 0 to 10, with higher scores indicating greater pain severity or greater interference with daily activities.
Time frame: Baseline, 4 weeks, and 8 weeks post-intervention
Duration of Second Stage of Labor
Duration of the second stage of labor obtained from medical records.
Time frame: At delivery
The Pittsburgh Sleep Quality Index (PSQI)
Scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame: Baseline, 4 weeks, and 8 weeks post-intervention
Pelvic Floor Muscle Exercise Self-Efficacy Scale
Scores range from 17 to 85, with higher scores indicating greater self-efficacy for performing pelvic floor muscle exercises.
Time frame: Baseline, 4 weeks, and 8 weeks post-intervention
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