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

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
PFMT
non PFMT
Sponsored by
Rajavithi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Incontinence focused on measuring urinary incontinence, pelvic floor muscle training, nulliparous, pregnancy

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Rajavithi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PFMT group

non PFMT

Arm 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

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

Outcomes

Primary Outcome Measures

Urinary incontinence at third trimester both group
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

Quality of life at third trimester both group
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
Duration of second stage of labor in both group
use 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 life
questionaire UDI-6 , IIQ-7 hypothesis high score of UDI6 associated poor quality of life

Full Information

First Posted
September 10, 2019
Last Updated
August 21, 2020
Sponsor
Rajavithi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04525846
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 23, 2019 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
urinary incontinence, pelvic floor muscle training, nulliparous, pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PFMT group
Arm Type
Experimental
Arm 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
Arm Title
non PFMT
Arm Type
Experimental
Arm 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
Intervention Type
Other
Intervention Name(s)
PFMT
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
non PFMT
Intervention Description
Randomized to non PFMT group follow up and evaluate UI at third trimester sames as intervention group
Primary Outcome Measure Information:
Title
Urinary incontinence at third trimester both group
Description
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 )
Time Frame
GA 36-38 wk
Secondary Outcome Measure Information:
Title
Quality of life at third trimester both group
Description
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
Time Frame
GA 36-38 wk
Title
Duration of second stage of labor in both group
Description
use partograph and labor record, Duration of second stage of labor define as times of cervical fully dilatation until baby delivery difine as minutes
Time Frame
date of delivery
Title
Correlation between urinary incontinence and quality of life
Description
questionaire UDI-6 , IIQ-7 hypothesis high score of UDI6 associated poor quality of life
Time Frame
GA 36-38 wk

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Rajavithi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
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A Comparison of Urinary Incontinence During Third Trimester of Nulliparous on Pelvic Floor Muscle Training

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