Back to resultsEffect of Global Postural Correction Exercises on Stress Urinary Incontinence During Pregnancy: A Randomized Controlled Trial
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Kegel exercises
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Kegel exercise, Postural Correction, Stress Urinary Incontinence
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
global postural correction exercises
Kegel exercises
Arm Description
global postural correction exercises in addition to Kegel exercises
only Kegel exercises
Outcomes
Primary Outcome Measures
strength of pelvic floor muscle
Secondary Outcome Measures
Urogenital Distress Inventory Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04253925
Brief Title
Effect of Global Postural Correction Exercises on Stress Urinary Incontinence During Pregnancy: A Randomized Controlled Trial
Official Title
Effect of Global Postural Correction Exercises on Stress Urinary Incontinence During Pregnancy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 2, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Kegel exercise, Postural Correction, Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
global postural correction exercises
Arm Type
Experimental
Arm Description
global postural correction exercises in addition to Kegel exercises
Arm Title
Kegel exercises
Arm Type
Active Comparator
Arm Description
only Kegel exercises
Intervention Type
Other
Intervention Name(s)
Kegel exercises
Intervention Description
global postural correction exercises
Primary Outcome Measure Information:
Title
strength of pelvic floor muscle
Time Frame
change from Baseline strength of pelvic floor muscle at 12-weeks
Secondary Outcome Measure Information:
Title
Urogenital Distress Inventory Questionnaire
Time Frame
change from Baseline Urogenital Distress Inventory Questionnaire (UDI-6) at 12-weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Global Postural Correction Exercises on Stress Urinary Incontinence During Pregnancy: A Randomized Controlled Trial
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