PFU vs. UDS in SUI

NCT06886997 | Not Yet Recruiting

• 1 other identifier: UDS-PFU
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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?

Conditions

Stress Urinary Incontinence (SUI)

Outcome Measures

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)

  Within a week of UDS appointment

Secondary Outcomes (2)

• Patient satisfaction

  Within a week of UDS appointment

• Cost

  Within a week of UDS appointment

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

adult women complaining of stress urinary incontinence

You may qualify if:

• Aged ≥ 18 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (8)

• Yao M, Simoes A. Urodynamic Testing and Interpretation. 2023 Aug 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK562310/

  PMID: 32965981 BACKGROUND

• Pietrus M, Pitynski K, Socha MW, Gawron I, Biskupski-Brawura-Samaha R, Waligora M. Enhanced Non-Invasive Diagnosis of Female Urinary Incontinence Using Static and Functional Transperineal Ultrasonography. Diagnostics (Basel). 2024 Nov 14;14(22):2549. doi: 10.3390/diagnostics14222549.

  PMID: 39594215 BACKGROUND

• Malmur M, Mlodawski J, Mlodawska M, Misiek M, Adamczyk-Gruszka O, Niziurski P, Gluszek S, Rokita W. Could pelvic floor sonography be a standalone method for excluding genuine stress urinary incontinence in women? Ginekol Pol. 2023 Mar 17. doi: 10.5603/GP.a2023.0026. Online ahead of print.

  PMID: 36929790 BACKGROUND

• Lugo T, Leslie SW, Mikes BA, Riggs J. Stress Urinary Incontinence. 2024 Aug 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK539769/

  PMID: 30969591 BACKGROUND

• Hu Y, Lou YL, Zhu SX, Zhang H, Huang T, Wu H, Xie LP. Pelvic floor ultrasound versus urodynamics in evaluating insensible urinary incontinence: A retrospective study. Prog Urol. 2023 Jul;33(7):384-392. doi: 10.1016/j.purol.2023.05.002. Epub 2023 Jun 2.

  PMID: 37271669 BACKGROUND

• Dietz HP. Pelvic Floor Ultrasound: A Review. Clin Obstet Gynecol. 2017 Mar;60(1):58-81. doi: 10.1097/GRF.0000000000000264.

  PMID: 28005595 BACKGROUND

• Dietz HP. Pelvic floor ultrasound in incontinence: what's in it for the surgeon? Int Urogynecol J. 2011 Sep;22(9):1085-97. doi: 10.1007/s00192-011-1402-7. Epub 2011 Apr 22.

  PMID: 21512829 BACKGROUND

• Bahrami S, Khatri G, Sheridan AD, Palmer SL, Lockhart ME, Arif-Tiwari H, Glanc P. Pelvic floor ultrasound: when, why, and how? Abdom Radiol (NY). 2021 Apr;46(4):1395-1413. doi: 10.1007/s00261-019-02216-8.

  PMID: 31529202 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Urodynamics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 20, 2025
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-03