Efficacy of Contrast Enhanced Voiding Urosonography for Urodynamic Studies

Urologic Diseases Clinical Trial

Official title:

Efficacy of Contrast Enhanced Voiding Urosonography for Urodynamic Studies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04738539
• Other study ID #: HSR200346
• Status: Recruiting
• Start date: March 2, 2021
• Est. completion date: March 2, 2022

Study information

• Verified date: April 2021
• Source: University of Virginia
• Contact: Susan V Leroy, MSN
• Phone: 434-924-0123
• Email: svg5m[@]virginia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: March 2, 2022
• Est. primary completion date: March 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder, Neurogenic
• Meningomyelocele
• Myelomeningocele
• Neural Tube Defects
• Neurogenic Bladder
• Neurologic Dysfunction
• Neurologic Manifestations
• Tethered Cord Syndrome
• Urinary Bladder, Neurogenic
• Urologic Diseases

Intervention

Drug:
• Contrast Enhanced Voiding Urosonography with Urodynamic Testing
We will be using contrast enhanced voiding urosonography to image urodynamic testing on patients with neurogenic bladder.

Diagnostic Test:
• Urodynamic Testing
We will be using contrast enhanced voiding urosonography to image urodynamic testing on patients with neurogenic bladder.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

Fernbach SK, Feinstein KA, Schmidt MB. Pediatric voiding cystourethrography: a pictorial guide. Radiographics. 2000 Jan-Feb;20(1):155-68; discussion 168-71. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bladder shape and morphology	Comparison of previous fluroscopy images and ceVUS images	Procedure (At time of urodynamic investigation)
Primary	Bladder neck configuration	Comparison of previous fluroscopy images and ceVUS images	Procedure (At time of urodynamic investigation)
Primary	Structure of urethra	Comparison of previous fluroscopy images and ceVUS images	Procedure (At time of urodynamic investigation)
Primary	Presence and degree of VUR	Comparison of previous fluroscopy images and ceVUS images	Procedure (At time of urodynamic investigation)
Primary	Images of active voiding	Comparison of previous fluroscopy images and ceVUS images	Procedure (At time of urodynamic investigation)
Secondary	Patient/caregiver preference	Comparison survey	Immediately following urodynamic investigation or up to 7 days after by phone

External Links

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