Assessment of Prevalence of Stress Urinary Incontinence During Pregnancy

Suspended

• Conditions: Stress Urinary Incontinence
• Interventions: Other: questionnaire

• Registration Number: NCT03117504
• Lead Sponsor: Ain Shams Maternity Hospital

Brief Summary

Stress urinary incontinence is the most common type of incontinence during pregnancy.our study aims at determining the prevalence in the first and third trimesters and the associated risk factors.

Detailed Description

The required sample size has been calculated using IBM© Sample Power© version 3 .The primary outcome measure is the prevalence of stress urinary incontinence (SUI) in the 1st and 3rd trimesters.

Accordingly, it is estimated that a sample of 240 patients in either study group would have a power of 80% (beta error, 0.2) to detect a statistically significant difference of 9% between the two groups as regards the incidence of SUI.

The incidence of SUI is assumed to equal 10% in the 1st trimester. The prevalence of SUI in the 3rd trimester is assumed to equal 10% under the null hypothesis and to equal 19% under the alternative hypothesis.

This calculation used a two-sided z test with a confidence level of 95% (alpha error, 0.05).

Data will be collected, tabulated, then analyzed using IBM© SPSS© Statistics version 22.

Normally distributed numerical data will be presented as mean and SD, and skewed data as median and inter-quartile range.

Qualitative data will be presented as number and percentage.Comparison of normally distributed numerical data will be done using the unpaired Student t test. Skewed data will be compared using the Mann-Whitney U test.

Categorical data will be compared using the chi-squared test, or Fisher's exact test when appropriate.

A two-sided p-value \<0.05 will be considered statistically significant .

Study Timeline

• Study Start: 2016-01-05
• Study First Submitted: 2017-03-21
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-17
• Last Update Submitted: 2017-04-17
• Study First Posted: 2017-04-18
• Last Update Posted: 2017-04-18
• Primary Completion: 2017-05-20
• Study Completion: 2017-07-20

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• Pregnant women in first and third trimesters

Exclusion Criteria

• Communication problems.
• Mental disturbances.
• Previous surgery for incontinence or other pelvic procedures.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Third trimester	questionnaire	women during third trimester(more than 28 weeks of pregnancy) will complete self-reported questionnaires and undergo clinical examination to confirm the stress incontinence.
First trimester	questionnaire	women during first trimester(less than 14 weeks of pregnancy) will complete self-reported questionnaires and undergo clinical examination to confirm the stress incontinence.

Primary Outcome Measures

Name	Time	Method
Prevalence of stress urinary incontinence during first trimester pregnancy	2 years	Determine the prevalence and associated risk factors in the first trimester

Secondary Outcome Measures

Name	Time	Method
Prevalence of stress urinary incontinence during third trimester pregnancy	2 years	Determine the prevalence and associated risk factors in the third trimester

Trial Locations

Locations (1)

Ain Shams Faculty of Medicine; 🇪🇬 Cairo Governorate, Cairo, Egypt