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Completed

NCT Number: NCT04525846

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

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PFMT

Other
  • 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)

non PFMT

Other

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

Primary outcomes

  1. Urinary incontinence at third trimester both group

    Time frame: 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 outcomes

  1. Quality of life at third trimester both group

    Time frame: 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

  2. Duration of second stage of labor in both group

    Time frame: 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

  3. Correlation between urinary incontinence and quality of life

    Time frame: GA 36-38 wk

    questionaire UDI-6 , IIQ-7 hypothesis high score of UDI6 associated poor quality of life

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 25, 2020
Registry last updated
Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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