Stress Urinary Incontinence (SUI)
Conditions
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?
Interventions
DIAGNOSTIC_TESTPelvic Floor Ultrasound
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.
DIAGNOSTIC_TESTUrodynamic studies
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.
Sponsors
Ain Shams University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of pelvic floor ultrasound in assessment of stress urinary incontinence compared to urodynamic testing. | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | Within a week of UDS appointment | Patient satisfaction by asking which test would she prefer to repeat if needed: the urodynamic study, pelvic floor sonography, or neither? |
| Cost | Within a week of UDS appointment | Cost in Egyptian Pounds EGP |
Outcome results
None listed