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

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).

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence; Sense of Touch; Physical Symptoms; Kegel's Exercise
• Intervention / Treatment: Behavioral: Basic Health Education Group; Behavioral: Pelvic floor muscle training; Behavioral: Tactile pelvic floor muscle training group

Detailed Description

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
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	Baseline, 4 weeks, and 8 weeks post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Second Stage of Labor	Duration of the second stage of labor obtained from medical records.	At delivery
The Pittsburgh Sleep Quality Index (PSQI)	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	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

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2023
• Primary Completion (Actual): May 5, 2025
• Study Completion (Actual): May 5, 2025

Study Registration Dates

• First Submitted: May 27, 2025
• First Submitted That Met QC Criteria: June 19, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): August 19, 2026
• Last Update Submitted That Met QC Criteria: August 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; urinary incontinence; second stage of labor; life troubles
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: 111302-F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Based on personal data privacy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No