- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02139956
Assessment of the Internal Urethral Sphincter and the Vagina by Three Dimensional Ultrasound
May 15, 2014 updated by: dr mervat ekky, Ain Shams University
Ultrasonic Assessment of the Urethra and the Vagina in Normal Continent Women and Women Suffering From Stress Urinary Incontinence
Continent women have an intact internal urethral sphincter that extends from the bladder neck down to the perineal membrane.
The internal urethral sphincter is a strong collagen muscle tissue cylinder lined by urothelium.
On ultrasound scanning tissue echo will be detected torn internal urethral sphincter will not stand sudden rise of abdominal pressure.
Three dimensional ultrasound assessment of the internal urethral sphincter is very sensitive and specific for the diagnosis of stress urinary incontinence.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
The internal urethral sphincter used to be said it's a muscular ring but the investigators will visualize by three dimensional ultrasound it's a cylinder in shape and it's the cause of stress urinary incontinence by being torn by stretching the vagina during normal delivery.
Study Type
Observational
Enrollment (Actual)
140
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cairo, Egypt, 00202
- Ain Shams University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
out patient [clinics] and in patient
Description
Inclusion Criteria:
- signed an informed consent
- patient with stress urinary incontinence
- patient have done a vaginal delivery
- patient with genital prolapse
Exclusion Criteria:
- refusal to sign an informed consent
- patient have urinary tract infection
- patient with pregnancy
- patient have vaginal infection
- patient who has undiagnosed vaginal bleeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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stress urinary incontinence
group 1 women with stress urinary incontinence by ultrasonography
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open
Other Names:
|
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continent group
group 2 women without stress urinary incontinence by ultrasonography
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open
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
evaluation of the internal urethral sphincter and assesst the extend and degree of the torn internal urethral sphincter
Time Frame: 6 month
|
we are going to do 3d ultrasound by transvaginal probe to see the internal urethral sphincter if torn or not and evaluate the morphology of the urethra and pelvic floor structure
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
May 6, 2014
First Submitted That Met QC Criteria
May 15, 2014
First Posted (Estimate)
May 16, 2014
Study Record Updates
Last Update Posted (Estimate)
May 16, 2014
Last Update Submitted That Met QC Criteria
May 15, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- mekky
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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