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

NCT ID: NCT04170413

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-11-02

Brief Summary

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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

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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.

Conditions

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Neurogenic Bladder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CeVUS Urodynamic

patients undergoing urodynamic study with CeVUS

CeVUS

Intervention Type DRUG

Contrast enhanced voiding urosonography

Interventions

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CeVUS

Contrast enhanced voiding urosonography

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Reza Daugherty, MD

Associate Professor of Radiology and Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reza Daugherty, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia Health System

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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14717

Identifier Type: -

Identifier Source: org_study_id