Efficacy of Contrast Enhanced Voiding Urosonography for Urodynamic Studies

NCT04738539 | Unknown DMC FDA Drug

• 1 other identifier: HSR200346
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will assess the feasibility of replacing fluoroscopy/iodinated contrast with ultrasound/sulfur hexafluoride lipid-type A microspheres during routine urodynamic studies.

Conditions

Myelomeningocele; Neurogenic Bladder; Tethered Cord Syndrome; Bladder, Neurogenic; Urologic Diseases; Neurologic Dysfunction

Keywords

Contrast Enhanced Voiding Urosonography; Urodynamics; Neurogenic Bladder; Detrusor Sphincter Dyssynergia

Outcome Measures

Primary Outcomes (5)

• Bladder shape and morphology

  Comparison of previous fluroscopy images and ceVUS images

  Procedure (At time of urodynamic investigation)

• Bladder neck configuration

  Comparison of previous fluroscopy images and ceVUS images

  Procedure (At time of urodynamic investigation)

• Structure of urethra

  Comparison of previous fluroscopy images and ceVUS images

  Procedure (At time of urodynamic investigation)

• Presence and degree of VUR

  Comparison of previous fluroscopy images and ceVUS images

  Procedure (At time of urodynamic investigation)

• Images of active voiding

  Comparison of previous fluroscopy images and ceVUS images

  Procedure (At time of urodynamic investigation)

Secondary Outcomes (1)

• Patient/caregiver preference

  Immediately following urodynamic investigation or up to 7 days after by phone

Study Arms (1)

Patients with or being evaluated for neurogenic bladder

Pediatric patients presenting to UVA Pediatric Urology for follow up or repeat urodynamics testing.

Drug: Contrast Enhanced Voiding Urosonography with Urodynamic Testing; Diagnostic Test: Urodynamic Testing

Interventions

Contrast Enhanced Voiding Urosonography with Urodynamic Testing DRUG

We will be using contrast enhanced voiding urosonography to image urodynamic testing on patients with neurogenic bladder.

Also known as: CeVUS, Contrast Enhanced Voiding Urosonography

Patients with or being evaluated for neurogenic bladder

Urodynamic Testing DIAGNOSTIC_TEST

We will be using contrast enhanced voiding urosonography to image urodynamic testing on patients with neurogenic bladder.

Also known as: Urodynamics

Patients with or being evaluated for neurogenic bladder

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients presenting to UVA Pediatric Urology for follow up or repeat urodynamics study.

You may qualify if:

• Age 0-17
• Must have had prior urodynamic study at UVA

You may not qualify if:

• Pregnant women (self-reported)
• Fetuses
• Neonates
• Prisoners
• Subjects with preexisting cardiac conditions (such as CHF and ventricular arrhythmias)
• Subjects with a known hypersensitivity to Lumason

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22911, United States

RECRUITING

Related Publications (3)

• Drzewiecki BA, Bauer SB. Urodynamic testing in children: indications, technique, interpretation and significance. J Urol. 2011 Oct;186(4):1190-7. doi: 10.1016/j.juro.2011.02.2692. Epub 2011 Aug 16.

  PMID: 21849190 BACKGROUND

• Fernbach SK, Feinstein KA, Schmidt MB. Pediatric voiding cystourethrography: a pictorial guide. Radiographics. 2000 Jan-Feb;20(1):155-68; discussion 168-71. doi: 10.1148/radiographics.20.1.g00ja12155.

  PMID: 10682779 BACKGROUND

• Mane N, Sharma A, Patil A, Gadekar C, Andankar M, Pathak H. Comparison of contrast-enhanced voiding urosonography with voiding cystourethrography in pediatric vesicoureteral reflux. Turk J Urol. 2018 May;44(3):261-267. doi: 10.5152/tud.2018.76702. Epub 2018 Mar 6.

  PMID: 29733800 BACKGROUND

Related Links

• Feasibility of Using Contrast Enhanced Voiding Urosonography (CeVUS) During Urodynamic Studies (NCT04170413)

MeSH Terms

Conditions

Meningomyelocele; Urinary Bladder, Neurogenic; Neural Tube Defects; Urologic Diseases; Neurologic Manifestations

Interventions

Urodynamics

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Nora G Kern, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan V Leroy, MSN

CONTACT

434-924-0123; svg5m@virginia.edu

Nora G Kern, MD

CONTACT

434-924-0123; ngl2z@virginia.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Urology

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 4, 2021
• Study Start: March 2, 2021
• Primary Completion: March 2, 2022
• Study Completion: March 2, 2022
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)