Clinical trial NCT06886997: PFU vs. UDS in SUI
Official title: Pelvic Floor Ultrasound Versus Urodynamic Studies in Evaluating Women With Stress Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stress Urinary Incontinence (SUI)
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult women complaining of stress urinary incontinence

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?


Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of pelvic floor ultrasound in assessment of stress urinary incontinence compared to urodynamic testing.
timeFrame: Within a week of UDS appointment
Secondary outcomes:
measure: Patient satisfaction
timeFrame: Within a week of UDS appointment
measure: Cost
timeFrame: Within a week of UDS appointment
Other outcomes:
Locations:
Study officials:
References:
citation: 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/
citation: 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.
citation: 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.
citation: 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/
citation: 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.
citation: Dietz HP. Pelvic Floor Ultrasound: A Review. Clin Obstet Gynecol. 2017 Mar;60(1):58-81. doi: 10.1097/GRF.0000000000000264.
citation: 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.
citation: 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.