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Clinical Trials/NCT06886997
NCT06886997Not yet recruitingNot Applicable

Pelvic Floor Ultrasound Versus Urodynamic Studies in Evaluating Women With Stress Urinary Incontinence

Ain Shams University0 sites50 target enrollmentStarted: June 1, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
50
Primary Endpoint
Accuracy of pelvic floor ultrasound in assessment of stress urinary incontinence compared to urodynamic testing.

Study Overview

Brief Summary

The goal of this observational stury is to test the diagnostic accuracy of Pelvic Floor Ultrasound in evaluating women with stress urinary incontinence compared to the reference standard Urodynamic Studies. The main question it aims to answer is:

Is Pelvic floor ultrasound as accurate as urodynamic studies in diagnosis of stress urinary incontinence?

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Aged ≥ 18 years

Exclusion Criteria

  • Medical history of neurological disorders, cognitive disorders, dementia, Alzheimer's disease, or uncontrolled DM.
  • Surgical history of continence or prolapse procedure.
  • Examination showing anterior or middle compartment decent with POP-Q staging greater than stage 1, or urogenital fistula.
  • Known lower urinary tract or genital tract anomalies or tumors.

Outcomes

Primary Outcomes

Accuracy of pelvic floor ultrasound in assessment of stress urinary incontinence compared to urodynamic testing.

Time Frame: Within a week of UDS appointment

Key Measurements in PFU: Bladder neck position at resting and Valsalva states. Bladder Neck Mobility Posterior vesicourethral angle Urethral inclination angle Distance from the external urethral orifice to the bladder neck at resting state. Bladder Neck Funneling (BNF) Key Parameters Measured in Urodynamics: Presence or absence of SUI Presence or absence of Detrusor Overactivity leak point pressure Diagnostic accuracy will be assessed according to (sensitivity, specificity, positive and negative predictive values) of PFU compared to UDS (as the gold standard)

Secondary Outcomes

  • Cost(Within a week of UDS appointment)
  • Patient satisfaction(Within a week of UDS appointment)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Salma Salah Eltounsi

Trainee

Ain Shams University

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