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Assessment of the Internal Urethral Sphincter and the Vagina by Three Dimensional Ultrasound

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ClinicalTrials.gov Identifier: NCT02139956
Recruitment Status : Unknown
Verified May 2014 by dr mervat ekky, Ain Shams University.
Recruitment status was:  Active, not recruiting
First Posted : May 16, 2014
Last Update Posted : May 16, 2014
Sponsor:
Information provided by (Responsible Party):
dr mervat ekky, Ain Shams University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Urinary Incontinence Due to Urethral Sphincter Incompetence Device: ultrasonography

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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 140 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Days
Official Title: Ultrasonic Assessment of the Urethra and the Vagina in Normal Continent Women and Women Suffering From Stress Urinary Incontinence
Study Start Date : May 2014
Actual Primary Completion Date : May 2014

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Groups and Cohorts
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Group/Cohort Intervention/treatment
stress urinary incontinence
group 1 women with stress urinary incontinence by ultrasonography
 Device: ultrasonography
open
Other Names:
  • vilson E6
  • transvaginal probe
continent group
group 2 women without stress urinary incontinence by ultrasonography
 Device: ultrasonography
open
Other Names:
  • vilson E6
  • transvaginal probe


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
out patient [clinics] and in patient
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139956


Locations
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Egypt
Ain Shams University
Cairo, Egypt, 00202
Sponsors and Collaborators
Ain Shams University
More Information
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Additional Information:

Publications of Results:

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Responsible Party: dr mervat ekky, mekky, Ain Shams University
ClinicalTrials.gov Identifier: NCT02139956    
Other Study ID Numbers: mekky
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
 Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders