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

August 21, 2020 updated by: Rajavithi Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Rajavithi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PFMT group
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
Other: PFMT
  • 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)
EXPERIMENTAL: non PFMT
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
Other: non PFMT
Randomized to non PFMT group follow up and evaluate UI at third trimester sames as intervention group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 )
GA 36-38 wk

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
GA 36-38 wk
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
date of delivery
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
GA 36-38 wk

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rajavithi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 23, 2019

Primary Completion (ACTUAL)

May 31, 2020

Study Completion (ACTUAL)

June 30, 2020

Study Registration Dates

First Submitted

September 10, 2019

First Submitted That Met QC Criteria

August 21, 2020

First Posted (ACTUAL)

August 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 21, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 072/2562

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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