PFU vs. UDS in SUI

NCT ID: NCT06886997

Last Updated: 2025-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-01

Study Completion Date

2025-12-01

Brief Summary

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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?

Detailed Description

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Conditions

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Stress Urinary Incontinence (SUI)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Pelvic 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.

Intervention Type DIAGNOSTIC_TEST

Urodynamic 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Salma Salah Eltounsi

Trainee

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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/

Reference Type BACKGROUND
PMID: 32965981 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39594215 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36929790 (View on PubMed)

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/

Reference Type BACKGROUND
PMID: 30969591 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37271669 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 28005595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21512829 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31529202 (View on PubMed)

Other Identifiers

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UDS-PFU

Identifier Type: -

Identifier Source: org_study_id

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