Stress Urinary IncontinenceNCT07668128
Tactile Feedback Pelvic Floor Training to Prevent Stress Urinary Incontinence in the 3rd Trimester of Pregnancy
A study testing Pelvic floor muscle training, Basic Health Education Group and Tactile pelvic floor muscle training group in people with Stress Urinary Incontinence and Kegel's Exercise, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Stress Urinary Incontinence, Kegel's Exercise, Sense of Touch
- What is being tested?
- Pelvic floor muscle training, Basic Health Education Group and Tactile pelvic floor muscle training group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Mar 2023to 5 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Being tested
- Pelvic floor muscle training, Basic Health Education Group, Tactile pelvic floor muscle training group
- Keywords
- life troubles, quality of life, second stage of labor, urinary incontinence
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle trainingBehavioural
"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.
Basic Health Education GroupBehavioural
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.
Tactile pelvic floor muscle training groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Tactile pelvic floor muscle training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 4 weeks, and 8 weeks post-intervention
Secondary outcomes (3)
Duration of Second Stage of Labor
Duration of the second stage of labor obtained from medical records.
Measured: At delivery
The Pittsburgh Sleep Quality Index (PSQI)
Scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: 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.
Measured: Baseline, 4 weeks, and 8 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start8 Mar 2023
- Primary completion5 May 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm intervention model
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wel Chu, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668128
- Sponsor's protocol ID
- 111302-F
- Status last verified
- Jun 2026
- First submitted
- 27 May 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Based on personal data privacy
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07668128
- Acronym / sponsor ID
- 111302-F
- Keywords
- life troubles, quality of life, second stage of labor, urinary incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three-arm intervention model
| Arm | Type | Receives |
|---|---|---|
| Basic Health Education Group | Placebo comparator | Behavioral: Basic Health Education GroupParticipants 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. |
| Kegel Exercise Group | Active comparator | Behavioral: Pelvic floor muscle trainingParticipants 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. |
| Sensorimotor-Enhanced PFMT | Experimental | Behavioral: Tactile pelvic floor muscle training groupThis 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Kegel Exercise Group |
| Basic Health Education GroupOne-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. | Behavioural | Basic Health Education Group |
| Tactile pelvic floor muscle training groupThere 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. | Behavioural | Sensorimotor-Enhanced PFMT |
Primary outcome
Urinary Symptoms (Bladder Diary)
Time frame: 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.
Urinary Symptom Distress (UDI-6)
Time frame: 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.
Incontinence Impact on Daily Life (IIQ-7)
Time frame: 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.
Urinary Incontinence-Related Quality of Life (KHQ)
Time frame: 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.
Global Quality of Life (WHOQOL-BREF Taiwan Version)
Time frame: Baseline, 4 weeks, and 8 weeks post-intervention
Total 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)
Time frame: Baseline, 4 weeks, and 8 weeks post-intervention
Scores range from 0 to 21, with higher scores indicating greater urinary symptom severity.
Brief Pain Inventory(BPI)
Time frame: 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.
3 secondary outcomes
Duration of Second Stage of Labor
Time frame: At delivery
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 4 weeks, and 8 weeks post-intervention
Pelvic Floor Muscle Exercise Self-Efficacy Scale
Time frame: Baseline, 4 weeks, and 8 weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No. Based on personal data privacy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor muscle training, Basic Health Education Group and Tactile pelvic floor muscle training group in people with Stress Urinary Incontinence and Kegel's Exercise, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Symptoms (Bladder Diary) (time frame: Baseline, 4 weeks, and 8 weeks post-intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.