PFU vs. UDS in SUI

N/ANot Yet RecruitingNCT06886997

Ain Shams University50 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Stress Urinary Incontinence (SUI)

Interventions

Pelvic Floor UltrasoundDIAGNOSTIC_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 studiesDIAGNOSTIC_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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

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

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

Cost

Cost in Egyptian Pounds EGP

Time frame: Within a week of UDS appointment

Data from ClinicalTrials.gov

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