A Comparison of Urinary Incontinence During Third Trimester of Nulliparous on Pelvic Floor Muscle Training

Study Overview
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Brief Summary
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Comparison of urinary incontinence during third trimester of nulliparous on pelvic floor muscle training in Rajavithi hospital

Detailed Description
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Outcomes primary outcome >> UI at third trimester secondary outcome >> quality of life, duration of second stage of labor Inclusion criteria nulliparous GA 20-24 week gestation singleton Age 18-35 years old Can communicate and understand Thai language Cooperating to join research Exclusion criteria DFIU Maternal medical condition or high risk pregnancy such as multifetal gestation, chronic hypertension, pregestational DM, epilepsy, autoimmune disease, polyhydramnios asthma Pre-excisting urinary incontinence prepregnancy BMI>=30 kg/m2 smoking 2 groups study >> control and intervention group Both groups were evaluated urinary incontinence(UI) at third trimester with UDI-6 and IIQ-7 questionaires Intervention group was trianed pelvic floor muscle strength and evaluate strength with Brink score by researcher who was trained and tested pelvic floor muscle strength by urogynecologist at day 1 then reassess Brink score at 4 weeks program of pelvic floor muscle training ( PFMT) consist of contract and whole pelvic floor muscle 10 seconds and relaxation 10 second total 20 times per set total 3 set per day intervention group was followed up once a week by telephone about compliance of program, general symptom and notice for self recording sheet PFMT program follow up total 12 weeks

Official Title
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A Comparison of Urinary Incontinence During Third Trimester of Nulliparous on Pelvic Floor Muscle Training in Rajavithi Hospital

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Other: PFMT
* Other: non PFMT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: nulliparous gestational gae 20-24 week age 18-35 year can communicate and understand Thai language co-operate to join research Exclusion Criteria: DFIU maternal medical condition or high risk pregnancy such as multifetal gestation , pregestational DM, chonic hypertension , epilepsy, autoimmune disease, polyhydramnios, asthma pre-excisting urinary incontinence prepregnant BMI >=30 kg/m2 smoking

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: To compare urinary incontinence, qaulity of life, duration of second stage of labor between pelvic floor muscle training(PFMT) group and nonPFMT group Researcher assess pelvic floor muscle strength by Brink score who verified by urogynecologist , given PFMT program and VDO education, follow up by telephone for compliance, and reassess pelvic floor muscle strength at 4 weeks after consented
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PFMT group<br>Researcher was trained and test pelvic floor muscle strength by urogynecologist with Brink scores, participants PFMT group were educated by VDO and recieved program of PFMT after consented form 4 weeks reassess Brink score for check compliance of PFMT and followed up by telephone weekly about compliance of PFMT, general symptom, notice self recording book total 12 weeks and evaluate urinary incontinence by UDI-6 questionaires at third trimester | Other: PFMT<br>* program of PFMT consist of contract and hold pelvic floor muscle 10 seconds and relax 10 seconds 20 times per set totally 3 set per day follow up by telephone once a week about compliance of program PFMT, general symptoms, notice recording book at third trimester evaluate UI by questionaire (UDI-6, IIQ-7)<br>|
| Experimental: non PFMT<br>Randomized to non PFMT group watchful waiting until 36-38 week gestation follow up and evaluate UI by UDI6 questionaires at third trimester sames as intervention group | Other: non PFMT<br>* Randomized to non PFMT group follow up and evaluate UI at third trimester sames as intervention group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary incontinence at third trimester both group | Use Questionaires Urinary Distress Inventory (UDI-6) include 6 domains( Frequency, Urgency incontinence, Stress incontinence, Drops, Emptying difficulty, Pain /discomfort each domain raw score from 0-3 (0=not at all, 1= a little bit, 2=moderately, 3=greatly) (total raw score 18 point ) define score total 100 point if at least 16.7% means urinary incontinence and below 16.7% means nornal ( continence= no UI ) | GA 36-38 wk | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life at third trimester both group | Incontinence impact questionaires (IIQ-7) includes Household chores, Physical recreation, Entertainment activities, Travel ability, Social activities, Emotional health, Feeling frustrated. Each domain has raw score 0-3 (0=not at all, 1= a little bit, 2=moderately, 3=greatly), total raw score 21 points. It's defined total score 100 point if at least 70 means impact qaulity of life | GA 36-38 wk | 
| Duration of second stage of labor in both group | use partograph and labor record, Duration of second stage of labor define as times of cervical fully dilatation until baby delivery difine as minutes | date of delivery | 
| Correlation between urinary incontinence and quality of life | questionaire UDI-6 , IIQ-7 hypothesis high score of UDI6 associated poor quality of life | GA 36-38 wk | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary incontinence, pelvic floor muscle training, nulliparous, pregnancy