Assessment of the Internal Urethral Sphincter and the Vagina by Three Dimensional Ultrasound
Ultrasonic Assessment of the Urethra and the Vagina in Normal Continent Women and Women Suffering From Stress Urinary Incontinence
1 other identifier
observational
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 6, 2014
CompletedFirst Posted
Study publicly available on registry
May 16, 2014
CompletedMay 16, 2014
May 1, 2014
Same day
May 6, 2014
May 15, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
evaluation of the internal urethral sphincter and assesst the extend and degree of the torn internal urethral sphincter
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
Study Arms (2)
stress urinary incontinence
group 1 women with stress urinary incontinence by ultrasonography
continent group
group 2 women without stress urinary incontinence by ultrasonography
Interventions
open
Eligibility Criteria
out patient \[clinics\] and in patient
You may qualify if:
- signed an informed consent
- patient with stress urinary incontinence
- patient have done a vaginal delivery
- patient with genital prolapse
You may not qualify if:
- refusal to sign an informed consent
- patient have urinary tract infection
- patient with pregnancy
- patient have vaginal infection
- patient who has undiagnosed vaginal bleeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University
Cairo, 00202, Egypt
Related Publications (1)
Kruger JA, Dietz HP, Budgett SC, Dumoulin CL. Comparison between transperineal ultrasound and digital detection of levator ani trauma. Can we improve the odds? Neurourol Urodyn. 2014 Mar;33(3):307-11. doi: 10.1002/nau.22386. Epub 2013 Feb 22.
PMID: 23436235RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 2 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- mekky
Study Record Dates
First Submitted
May 6, 2014
First Posted
May 16, 2014
Study Start
May 1, 2014
Primary Completion
May 1, 2014
Last Updated
May 16, 2014
Record last verified: 2014-05