Effect of Global Postural Correction Exercises on Stress Urinary Incontinence During Pregnancy: A Randomized Controlled Trial
January 31, 2020 updated by: HAhmed, Cairo University
Background: One of the many consequences of pregnancy that may negatively affect a woman's quality of life is stress urinary incontinence caused by activities of daily living especially those associated with increased intraabdominal pressure.
Objective: This study aimed to investigate the effect of global postural correction exercises on stress urinary incontinence among pregnant women.
Participants and Methods: Forty primigravida women (aged between 30-39 years), with a single fetus, diagnosed with stress urinary incontinence participated in the study.
Participants were assigned randomly into two groups: Study group (group A; n=20) and control group (group B; n=20).
The participants were tested twice, before and after a 12-week period, during which group A received global postural correction exercises in addition to Kegel exercises, while group B performed only Kegel exercises.
A perineometer was used to evaluate the change in vaginal squeeze pressure both before and after conducting the study.
Urogenital Distress Inventory Questionnaire (UDI-6) was used to assess changes in incontinence severity symptoms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Forty primigravida women with singleton fetus in their third trimester and diagnosed with pregnancy related SUI participated in this study.
All participants suffered from a mild to moderate grade of SUI identified by clinical grading (Ingelman-Sundberg) (Wlazlak et al., 2015) as follows: Grade I (mild), the leakage of urine occurs on straining; and grade II (moderate), the leakage occurs following abrupt movement
Exclusion Criteria:
- Females were excluded from the study if they had severe grade SUI; infections in their lower urinary tract; neurological conditions; gestational diabetes; and chronic chest diseases. Females who smoked, used any medications or medical/surgical interventions for SUI, or who suffered any other type of urinary incontinence were also excluded from the study
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: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: global postural correction exercises
global postural correction exercises in addition to Kegel exercises
|
global postural correction exercises
|
|
ACTIVE_COMPARATOR: Kegel exercises
only Kegel exercises
|
global postural correction exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
strength of pelvic floor muscle
Time Frame: change from Baseline strength of pelvic floor muscle at 12-weeks
|
change from Baseline strength of pelvic floor muscle at 12-weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Urogenital Distress Inventory Questionnaire
Time Frame: change from Baseline Urogenital Distress Inventory Questionnaire (UDI-6) at 12-weeks
|
change from Baseline Urogenital Distress Inventory Questionnaire (UDI-6) at 12-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 1, 2017
Primary Completion (ACTUAL)
January 2, 2018
Study Completion (ACTUAL)
December 1, 2018
Study Registration Dates
First Submitted
January 31, 2020
First Submitted That Met QC Criteria
January 31, 2020
First Posted (ACTUAL)
February 5, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 5, 2020
Last Update Submitted That Met QC Criteria
January 31, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/00976
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.