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Efficacy of Contrast Enhanced Voiding Urosonography for Urodynamic Studies

Efficacy of Contrast Enhanced Voiding Urosonography for Urodynamic Studies

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04738539
Enrollment
105
Registered
2021-02-04
Start date
2021-03-02
Completion date
2022-03-02
Last updated
2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Detailed description

Urodynamic studies routinely involve instillation of iohexol (OmnipaqueTM), a low osmolality contrast agent, into the bladder followed by fluoroscopic imaging to assess for reflux or variant anatomy of the genitourinary system. Recently, sulfur hexafluoride lipid-type A microspheres (LumasonTM), an ultrasound contrast agent, has been approved in the United States for intravesicular administration in the pediatric population. Contrast enhanced voiding urosonography (CEvUS) is being increasingly utilized in the place of voiding cystourethrograms, with the major advantages being decreased (zero) radiation for the patient, as well as decreased cost. Given the similarity in procedure between urodynamic studies (UDS) and voiding cystourethrograms, we hypothesize that a urodynamic study may be performed with contrast enhanced ultrasound instead of fluoroscopy. We plan to continue enrollment from our feasibility study and perform an efficacy study by recruiting a group of 105 patients under the age of 18, who are willing to undergo their normally schedule UDS using CEvUS to image the study in place of fluoroscopy. The UDS typically consists of two cycles of bladder filling and voiding; we intend replace the use of fluoroscopy and iohexel with ultrasound and sulfur hexafluoride lipid-type A microspheres. This will decrease the time commitment and eliminate radiation exposure for the patient. Data to be analyzed will include images from the study and patient/caregiver preference. Results from the ceVUS images will be compared to images obtained during previous tests imaged with fluoroscopy from the same patients currently enrolled in this study. Bladder shape and morphology, bladder neck configuration and performance, structure of the urethra, presence and degree of vesicoureteral reflux, and active voiding images will all be compared to fluoroscopy images from previous studies. The purpose of the study is to demonstrate that ceVUS is effective as an imaging technique for urodynamic studies, with an ultimate goal of using ceVUS instead of fluoroscopy in all urodynamic and voiding studies in order to decrease pediatric radiation exposure. The hypothesis is that ceVUS will be as effective for imaging urodynamics studies as fluoroscopy.

Interventions

DRUGContrast Enhanced Voiding Urosonography with Urodynamic Testing

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

DIAGNOSTIC_TESTUrodynamic Testing

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

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Bladder shape and morphologyProcedure (At time of urodynamic investigation)Comparison of previous fluroscopy images and ceVUS images
Bladder neck configurationProcedure (At time of urodynamic investigation)Comparison of previous fluroscopy images and ceVUS images
Structure of urethraProcedure (At time of urodynamic investigation)Comparison of previous fluroscopy images and ceVUS images
Presence and degree of VURProcedure (At time of urodynamic investigation)Comparison of previous fluroscopy images and ceVUS images
Images of active voidingProcedure (At time of urodynamic investigation)Comparison of previous fluroscopy images and ceVUS images

Secondary

MeasureTime frameDescription
Patient/caregiver preferenceImmediately following urodynamic investigation or up to 7 days after by phoneComparison survey

Countries

United States

Contacts

Primary ContactSusan V Leroy, MSN
svg5m@virginia.edu434-924-0123
Backup ContactNora G Kern, MD
ngl2z@virginia.edu434-924-0123

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026