Health TrialsbyHealthPanel

PFU vs. UDS in SUI

ConditionStress Urinary Incontinence (SUI)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorAin Shams University

About this trial

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?

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged ≥ 18 years

Disqualifiers

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.

Trial population

adult women complaining of stress urinary incontinence

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Pelvic Floor Ultrasound

    Diagnostic test

    Pelvic Floor Ultrasound will be carried out by a sonographer expert in the technique and who will be blinded from the data of clinical examination as well as the UDS results. The 3D/4D abdominal ultrasound probe will be used to perform a transperineal scan to capture midsagittal pelvic floor views. The test will be conducted both at resting state and during the maximum Valsalva maneuver.

  • Urodynamic studies

    Diagnostic test

    Urodynamic studies (UDS) will be carried out according to the usual protocol and will include: cystometry, Valsalva leak point pressure, urethral pressure profile, and uroflowmetry.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

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)

Time frame
Within a week of UDS appointment

Secondary outcomes

1

Patient satisfaction

Patient satisfaction by asking which test would she prefer to repeat if needed: the urodynamic study, pelvic floor sonography, or neither?

Time frame
Within a week of UDS appointment
2

Cost

Cost in Egyptian Pounds EGP

Time frame
Within a week of UDS appointment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: