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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07668128
Enrollment
141
Registered
2026-06-25
Start date
2023-03-08
Completion date
2025-05-05
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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).

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.

Interventions

BEHAVIORALPelvic 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.

BEHAVIORALBasic 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.

BEHAVIORALTactile 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.

Sponsors

Far Eastern Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Three-arm intervention model

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Urinary Symptoms (Bladder Diary)Baseline, 4 weeks, and 8 weeks post-interventionMean 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.
Urinary Symptom Distress (UDI-6)Baseline, 4 weeks, and 8 weeks post-interventionTotal score measured using the Urinary Distress Inventory-6 (UDI-6). Scores range from 0 to 100, with higher scores indicating greater urinary symptom distress.
Incontinence Impact on Daily Life (IIQ-7)Baseline, 4 weeks, and 8 weeks post-interventionTotal 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.
Urinary Incontinence-Related Quality of Life (KHQ)Baseline, 4 weeks, and 8 weeks post-interventionDomain 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.
Global Quality of Life (WHOQOL-BREF Taiwan Version)Baseline, 4 weeks, and 8 weeks post-interventionTotal score measured using the WHOQOL-BREF Taiwan Version. Higher scores indicate better quality of life.
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form(ICIQ-UI-SF)Baseline, 4 weeks, and 8 weeks post-interventionScores range from 0 to 21, with higher scores indicating greater urinary symptom severity.
Brief Pain Inventory(BPI)Baseline, 4 weeks, and 8 weeks post-interventionScores range from 0 to 10, with higher scores indicating greater pain severity or greater interference with daily activities.

Secondary

MeasureTime frameDescription
Duration of Second Stage of LaborAt deliveryDuration of the second stage of labor obtained from medical records.
The Pittsburgh Sleep Quality Index (PSQI)Baseline, 4 weeks, and 8 weeks post-interventionScores range from 0 to 21, with higher scores indicating poorer sleep quality.
Pelvic Floor Muscle Exercise Self-Efficacy ScaleBaseline, 4 weeks, and 8 weeks post-interventionScores range from 17 to 85, with higher scores indicating greater self-efficacy for performing pelvic floor muscle exercises.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026