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

Feasibility of Using CeVUS During Urodynamic Studies

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

Study Overview

• Status: Completed
• Conditions: Neurogenic Bladder
• Intervention / Treatment: Drug: CeVUS

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, the investigators hypothesize that a urodynamic study may be performed with contrast enhanced ultrasound instead of fluoroscopy. The investigators plan to conduct a small feasibility study by recruiting a group of 30 patients under the age of 18, who are willing to undergo their normally scheduled UDS in addition to CEvUS. The UDS typically consists of two cycles of bladder filling and voiding; the investigators intend to replace the use of fluoroscopy and iohexol with ultrasound and sulfur hexafluoride lipid-type A microspheres. This will decrease the time commitment and eliminate radiation exposure for the patient. There will not be a formal analysis of data as the investigators are planning to test the feasibility of the procedure rather than gather any quantitative data. The goal of the study is to eventually implement CEvUS instead of fluoroscopy in all urodynamic and voiding studies if it is found to be a reasonable alternative. This will decrease pediatric radiation exposure, which will be especially important in the patients undergoing several studies each year.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908-0170
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Age 0-18
• Must have had prior urodynamic study at University of Virginia

Exclusion Criteria:

• Pregnant women
• Fetuses
• Neonates
• Prisoners
• Subjects with preexisting cardiac conditions (such as heart failure and ventricular arrhythmias)
• Subjects with a known hypersensitivity to Lumason

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CeVUS Urodynamic; patients undergoing urodynamic study with CeVUS	Drug: CeVUS; Contrast enhanced voiding urosonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with successful completion of urodynamics	All usual information gathered during urodynamics was able to be obtained	After enrollment of 30 patients, estimated 1 year

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Reza Daugherty, MD, University of Virginia Health System

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ACTUAL): November 2, 2020
• Study Completion (ACTUAL): November 2, 2020

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (ACTUAL): November 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: contrast ultrasound; urodynamics
• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Urinary Bladder, Neurogenic
• Other Study ID Numbers: 14717

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No