Clinical trial NCT03117504: Assessment of Prevalence of Stress Urinary Incontinence During Pregnancy
Official title: Assessment of Prevalence of Stress Urinary Incontinence During Pregnancy
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Stress Urinary Incontinence
Keywords: Stress urinary incontinence
SUI
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A cross-sectional study of two groups of women will be conducted. Each group consists of 250 patients with a total number of 500 patients

* group 1 : women during first trimester(less than 14 weeks of pregnancy).
* group 2: women during third trimester (more than 28 weeks of pregnancy).

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 .

Eligibility criteria: Inclusion Criteria:

* Pregnant women in first and third trimesters

Exclusion Criteria:

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

Primary outcomes:
measure: Prevalence of stress urinary incontinence during first trimester pregnancy
timeFrame: 2 years
Secondary outcomes:
measure: Prevalence of stress urinary incontinence during third trimester pregnancy
timeFrame: 2 years
Other outcomes:
Locations:
city: Cairo Governorate
country: Egypt
facility: Ain Shams Faculty of Medicine
state: Cairo
Study officials:
affiliation: Ain Shams Maternity Hospital
name: Hazem M Sammour, MD
role: STUDY_CHAIR
References: