Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-29 @ 4:50 PM
Study NCT ID:
NCT03117504
Status:
SUSPENDED
Last Update Posted:
2017-04-18
First Post:
2017-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Prevalence of Stress Urinary Incontinence During Pregnancy
Sponsor:
Ain Shams Maternity Hospital
Organization:
Study Overview
Official Title:
Assessment of Prevalence of Stress Urinary Incontinence During Pregnancy
Status:
SUSPENDED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 .
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: