NCT02139956

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 16, 2014

Completed
Last Updated

May 16, 2014

Status Verified

May 1, 2014

Enrollment Period

Same day

First QC Date

May 6, 2014

Last Update Submit

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

Device: ultrasonography

continent group

group 2 women without stress urinary incontinence by ultrasonography

Device: ultrasonography

Interventions

open

Also known as: vilson E6, transvaginal probe
continent groupstress urinary incontinence

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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.

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

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

Locations