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

Not Applicable

Completed

• Conditions: Urinary Incontinence
• Interventions: Other: PFMT; Other: non PFMT

• Registration Number: NCT04525846
• Lead Sponsor: Rajavithi Hospital

Brief Summary

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

Detailed Description

Outcomes

1. primary outcome \>\> UI at third trimester

2. 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

Study Timeline

• Study Start: 2019-08-23
• Study First Submitted: 2019-09-10
• Primary Completion: 2020-05-31
• Study Completion: 2020-06-30
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-21
• Last Update Submitted: 2020-08-21
• Study First Posted: 2020-08-25
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PFMT group	PFMT	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
non PFMT	non PFMT	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

Primary Outcome Measures

Name	Time	Method
Urinary incontinence at third trimester both group	GA 36-38 wk	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 )

Secondary Outcome Measures

Name	Time	Method
Quality of life at third trimester both group	GA 36-38 wk	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
Correlation between urinary incontinence and quality of life	GA 36-38 wk	questionaire UDI-6 , IIQ-7 hypothesis high score of UDI6 associated poor quality of life
Duration of second stage of labor in both group	date of delivery	use partograph and labor record, Duration of second stage of labor define as times of cervical fully dilatation until baby delivery difine as minutes

Trial Locations

Locations (1)

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand