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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04525846
Enrollment
150
Registered
2020-08-25
Start date
2019-08-23
Completion date
2020-06-30
Last updated
2020-08-25

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

Conditions

Urinary Incontinence

Keywords

urinary incontinence, pelvic floor muscle training, nulliparous, pregnancy

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

Interventions

OTHERPFMT

* 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)

OTHERnon PFMT

Randomized to non PFMT group follow up and evaluate UI at third trimester sames as intervention group

Sponsors

Department of Medical Services Ministry of Public Health of Thailand
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Urinary incontinence at third trimester both groupGA 36-38 wkUse 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

MeasureTime frameDescription
Quality of life at third trimester both groupGA 36-38 wkIncontinence 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
Duration of second stage of labor in both groupdate of deliveryuse partograph and labor record, Duration of second stage of labor define as times of cervical fully dilatation until baby delivery difine as minutes
Correlation between urinary incontinence and quality of lifeGA 36-38 wkquestionaire UDI-6 , IIQ-7 hypothesis high score of UDI6 associated poor quality of life

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026