Clinical trial NCT04525846: A Comparison of Urinary Incontinence During Third Trimester of Nulliparous on Pelvic Floor Muscle Training
Official title: A Comparison of Urinary Incontinence During Third Trimester of Nulliparous on Pelvic Floor Muscle Training in Rajavithi Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: urinary incontinence
pelvic floor muscle training
nulliparous
pregnancy
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2020-08-25
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Urinary incontinence at third trimester both group
timeFrame: GA 36-38 wk
Secondary outcomes:
measure: Quality of life at third trimester both group
timeFrame: GA 36-38 wk
measure: Duration of second stage of labor in both group
timeFrame: date of delivery
measure: Correlation between urinary incontinence and quality of life
timeFrame: GA 36-38 wk
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
References:
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