Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06886997

PFU vs. UDS in SUI

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?

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Stress Urinary Incontinence (SUI) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Patient satisfaction

    Time frame: 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?

  2. Cost

    Time frame: Within a week of UDS appointment

    Cost in Egyptian Pounds EGP

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Acronym: UDS - PFU

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2025
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.