Assessment of Prevalence of Stress Urinary Incontinence During Pregnancy

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.

Study Overview

• Status: Suspended
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Other: questionnaire

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 Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Cairo Governorate, Cairo, Egypt, 1156
      • Ain Shams Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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).

Description

Inclusion Criteria:

• Pregnant women in first and third trimesters

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
First trimester; women during first trimester(less than 14 weeks of pregnancy) will complete self-reported questionnaires and undergo clinical examination to confirm the stress incontinence.	Other: questionnaire; a questionnaire is given to each woman to determine the urinary incontinence and it's impact on quality of life.
Third trimester; women during third trimester(more than 28 weeks of pregnancy) will complete self-reported questionnaires and undergo clinical examination to confirm the stress incontinence.	Other: questionnaire; a questionnaire is given to each woman to determine the urinary incontinence and it's impact on quality of life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of stress urinary incontinence during first trimester pregnancy	Determine the prevalence and associated risk factors in the first trimester	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of stress urinary incontinence during third trimester pregnancy	Determine the prevalence and associated risk factors in the third trimester	2 years

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital
• Investigators: Study Chair: Hazem M Sammour, MD, Ain Shams Maternity Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2016
• Primary Completion (Anticipated): May 20, 2017
• Study Completion (Anticipated): July 20, 2017

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2017
• Last Update Submitted That Met QC Criteria: April 17, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Stress urinary incontinence; SUI
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: MNAAMonem

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No