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

R

Rajavithi Hospital

Status

Completed

Conditions

Urinary Incontinence

Treatments

Other: non PFMT
Other: PFMT

Study type

Interventional

Funder types

Other

Identifiers

NCT04525846
072/2562

Details and patient eligibility

About

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

Full 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

Enrollment

150 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

PFMT group
Experimental group
Description:
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
Treatment:
Other: PFMT
non PFMT
Experimental group
Description:
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
Treatment:
Other: non PFMT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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