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

Urinary Incontinence Due to Urethral Sphincter Incompetence Clinical Trial

Official title:

Ultrasonic Assessment of the Urethra and the Vagina in Normal Continent Women and Women Suffering From Stress Urinary Incontinence

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02139956
• Other study ID #: mekky
• Status: Active, not recruiting
• Phase: N/A
• First received: May 6, 2014
• Last updated: May 15, 2014
• Start date: May 2014

Study information

• Verified date: May 2014
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence Due to Urethral Sphincter Incompetence

Intervention

Device:
• ultrasonography
open

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes