Assessment of Prevalence of Stress Urinary Incontinence During Pregnancy

Stress Urinary Incontinence Clinical Trial

Official title:

Assessment of Prevalence of Stress Urinary Incontinence During Pregnancy

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03117504
• Other study ID #: MNAAMonem
• Status: Suspended
• Phase: N/A
• First received: March 21, 2017
• Last updated: April 17, 2017
• Start date: January 5, 2016
• Est. completion date: July 20, 2017

Study information

• Verified date: April 2017
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 500
• Est. completion date: July 20, 2017
• Est. primary completion date: May 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant women in first and third trimesters

Exclusion Criteria:

• Communication problems.

• Mental disturbances.

• Previous surgery for incontinence or other pelvic procedures.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Other:
• questionnaire
a questionnaire is given to each woman to determine the urinary incontinence and it's impact on quality of life.

Locations

Country	Name	City	State
Egypt	Ain Shams Faculty of Medicine	Cairo Governorate	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of stress urinary incontinence during first trimester pregnancy	Determine the prevalence and associated risk factors in the first trimester	2 years
Secondary	Prevalence of stress urinary incontinence during third trimester pregnancy	Determine the prevalence and associated risk factors in the third trimester	2 years