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

• Sponsor: University of Virginia (Other)
• Overall Status: Completed
• CT.gov ID: NCT04170413
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Actual Duration (Months): 10.1
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neurogenic Bladder	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 Design

• Study Type: Observational
• Actual Enrollment: 25 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Feasibility of Using CeVUS During Urodynamic Studies
• Actual Study Start Date: Jan 1, 2020
• Actual Primary Completion Date: Nov 2, 2020
• Actual Study Completion Date: Nov 2, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Participants with successful completion of urodynamics [After enrollment of 30 patients, estimated 1 year]

   All usual information gathered during urodynamics was able to be obtained

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Virginia	Charlottesville	Virginia	United States	22908-0170

Sponsors and Collaborators

• University of Virginia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Reza Daugherty, MD, Associate Professor of Radiology and Pediatrics, University of Virginia
• ClinicalTrials.gov Identifier: NCT04170413
• Other Study ID Numbers: 14717
• First Posted: Nov 20, 2019
• Last Update Posted: Nov 4, 2020
• Last Verified: Nov 1, 2020

• 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
• Keywords provided by Reza Daugherty, MD, Associate Professor of Radiology and Pediatrics, University of Virginia: contrast ultrasound; urodynamics
• Additional relevant MeSH terms: Urinary Bladder, Neurogenic

Study Results

No Results Posted as of Nov 4, 2020