Clinical trial NCT04738539: Efficacy of Contrast Enhanced Voiding Urosonography for Urodynamic Studies
Official title: Efficacy of Contrast Enhanced Voiding Urosonography for Urodynamic Studies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myelomeningocele
Neurogenic Bladder
Tethered Cord Syndrome
Bladder, Neurogenic
Urologic Diseases
Neurologic Dysfunction
Keywords: Contrast Enhanced Voiding Urosonography
Urodynamics
Neurogenic Bladder
Detrusor Sphincter Dyssynergia
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 105
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients presenting to UVA Pediatric Urology for follow up or repeat urodynamics study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bladder shape and morphology
timeFrame: Procedure (At time of urodynamic investigation)
measure: Bladder neck configuration
timeFrame: Procedure (At time of urodynamic investigation)
measure: Structure of urethra
timeFrame: Procedure (At time of urodynamic investigation)
measure: Presence and degree of VUR
timeFrame: Procedure (At time of urodynamic investigation)
measure: Images of active voiding
timeFrame: Procedure (At time of urodynamic investigation)
Secondary outcomes:
measure: Patient/caregiver preference
timeFrame: Immediately following urodynamic investigation or up to 7 days after by phone
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Nora G Kern, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.