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

NCT07668128 | Completed DMC

• 1 other identifier: 111302-F
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Stress Urinary Incontinence; Kegel's Exercise; Sense of Touch; Physical Symptoms

Keywords

life troubles; quality of life; second stage of labor; urinary incontinence

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (1)

• Duration of Second Stage of Labor

  At delivery

Study Arms (3)

Basic Health Education Group

PLACEBO COMPARATOR

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

Kegel Exercise Group

ACTIVE COMPARATOR

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

Sensorimotor-Enhanced PFMT

EXPERIMENTAL

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

Interventions

Pelvic floor muscle training BEHAVIORAL

"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.

Kegel Exercise Group

Basic Health Education Group BEHAVIORAL

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.

Basic Health Education Group

Tactile pelvic floor muscle training group BEHAVIORAL

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.

Sensorimotor-Enhanced PFMT

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, Banqiao Dist, Taiwan

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three-arm intervention model

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 25, 2026
• Study Start: March 8, 2023
• Primary Completion: May 5, 2025
• Study Completion: May 5, 2025
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)