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Completed

NCT Number: NCT04170413

Feasibility of Using Contrast Enhanced Voiding Urosonography (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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CeVUS

Drug

Contrast enhanced voiding urosonography

Primary outcomes

  1. Number of Participants with successful completion of urodynamics

    Time frame: After enrollment of 30 patients, estimated 1 year

    All usual information gathered during urodynamics was able to be obtained

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

Feasibility of Using CeVUS During Urodynamic Studies

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 20, 2019
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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