NCT04253925

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

January 31, 2020

Last Update Submit

January 31, 2020

Conditions

Keywords

Kegel exercisePostural CorrectionStress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • strength of pelvic floor muscle

    change from Baseline strength of pelvic floor muscle at 12-weeks

Secondary Outcomes (1)

  • Urogenital Distress Inventory Questionnaire

    change from Baseline Urogenital Distress Inventory Questionnaire (UDI-6) at 12-weeks

Study Arms (2)

global postural correction exercises

EXPERIMENTAL

global postural correction exercises in addition to Kegel exercises

Other: Kegel exercises

Kegel exercises

ACTIVE COMPARATOR

only Kegel exercises

Other: Kegel exercises

Interventions

global postural correction exercises

Kegel exercisesglobal postural correction exercises

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecture of biomechanics

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 5, 2020

Study Start

January 1, 2017

Primary Completion

January 2, 2018

Study Completion

December 1, 2018

Last Updated

February 5, 2020

Record last verified: 2020-01