Stress Urinary IncontinenceNCT03117504
Assessment of Prevalence of Stress Urinary Incontinence During Pregnancy
An observational study of Stress Urinary Incontinence, run by Ain Shams Maternity Hospital at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- questionnaire
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2016to 20 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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).
Who may be able to join
- Pregnant women in first and third trimesters
Who cannot join
- Communication problems.
- Mental disturbances.
- Previous surgery for incontinence or other pelvic procedures.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ain Shams Faculty of Medicine
Cairo Governorate, Cairo Governorate, 1156
About this study
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.
Read the 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 .
- Conditions
- Stress Urinary Incontinence
- Being tested
- questionnaire
- Keywords
- Stress urinary incontinence, SUI
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
a questionnaire is given to each woman to determine the urinary incontinence and it's impact on quality of life.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: questionnaire | |
| 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. Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of stress urinary incontinence during first trimester pregnancy
Determine the prevalence and associated risk factors in the first trimester
Measured: 2 years
Secondary outcomes (1)
Prevalence of stress urinary incontinence during third trimester pregnancy
Determine the prevalence and associated risk factors in the third trimester
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start5 Jan 2016
- Primary completion20 May 2017 (estimated)
- Study completion20 Jul 2017 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Nour Allah Abdel Monem, Ain Shams Maternity Hospital
- Investigators
- Hazem M Sammour, MD, Study chair, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117504
- Sponsor's protocol ID
- MNAAMonem
- Status last verified
- Apr 2017
- First submitted
- 21 Mar 2017
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Prevalence of Stress Urinary Incontinence During Pregnancy
- ClinicalTrials.gov ID
- NCT03117504
- Acronym / sponsor ID
- MNAAMonem
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress urinary incontinence, SUI
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: lack of funding
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 5 Jan 2016 (actual)
- Primary completion
- 20 May 2017 (estimated)
- Study completion
- 20 Jul 2017 (estimated)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First trimester | – | Other: questionnairewomen during first trimester(less than 14 weeks of pregnancy) will complete self-reported questionnaires and undergo clinical examination to confirm the stress incontinence. |
| Third trimester | – | Other: questionnairewomen during third trimester(more than 28 weeks of pregnancy) will complete self-reported questionnaires and undergo clinical examination to confirm the stress incontinence. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Pregnant women in first and third trimesters
Key exclusion criteria (3 listed)
- Communication problems.
- Mental disturbances.
- Previous surgery for incontinence or other pelvic procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairea questionnaire is given to each woman to determine the urinary incontinence and it's impact on quality of life. | Other | First trimester, Third trimester |
Primary outcome
Prevalence of stress urinary incontinence during first trimester pregnancy
Time frame: 2 years
Determine the prevalence and associated risk factors in the first trimester
1 secondary outcome
Prevalence of stress urinary incontinence during third trimester pregnancy
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Stress Urinary Incontinence
RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hazem M Sammour, MD study chair
Ain Shams Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence, run by Ain Shams Maternity Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of stress urinary incontinence during first trimester pregnancy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.