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

17 augustus 2026 bijgewerkt door: 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).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

141

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: 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.
Gedragsmatig: 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.
Actieve vergelijker: 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.
Gedragsmatig: 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.
Experimenteel: 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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Urinary Symptoms (Bladder Diary)
Tijdsspanne: Baseline, 4 weeks, and 8 weeks post-intervention
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)
Tijdsspanne: Baseline, 4 weeks, and 8 weeks post-intervention
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)
Tijdsspanne: Baseline, 4 weeks, and 8 weeks post-intervention
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)
Tijdsspanne: Baseline, 4 weeks, and 8 weeks post-intervention
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)
Tijdsspanne: Baseline, 4 weeks, and 8 weeks post-intervention
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)
Tijdsspanne: Baseline, 4 weeks, and 8 weeks post-intervention
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)
Tijdsspanne: Baseline, 4 weeks, and 8 weeks post-intervention
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Duration of Second Stage of Labor
Tijdsspanne: At delivery
Duration of the second stage of labor obtained from medical records.
At delivery
The Pittsburgh Sleep Quality Index (PSQI)
Tijdsspanne: Baseline, 4 weeks, and 8 weeks post-intervention
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
Tijdsspanne: Baseline, 4 weeks, and 8 weeks post-intervention
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Far Eastern Memorial Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

8 maart 2023

Primaire voltooiing (Werkelijk)

5 mei 2025

Studie voltooiing (Werkelijk)

5 mei 2025

Studieregistratiedata

Eerst ingediend

27 mei 2025

Eerst ingediend dat voldeed aan de QC-criteria

19 juni 2026

Eerst geplaatst (Werkelijk)

25 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

17 augustus 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 111302-F

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Based on personal data privacy

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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