Efficacy of Contrast Enhanced Voiding Urosonography for Urodynamic Studies

April 27, 2021 updated by: Nora Kern, MD, University of Virginia
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

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, 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.

Study Type

Observational

Enrollment (Anticipated)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Recruiting
        • University of Virginia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

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 0-17
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with or being evaluated for neurogenic bladder
Pediatric patients presenting to UVA Pediatric Urology for follow up or repeat urodynamics testing.
We will be using contrast enhanced voiding urosonography to image urodynamic testing on patients with neurogenic bladder.
Other Names:
  • CeVUS
  • Contrast Enhanced Voiding Urosonography
We will be using contrast enhanced voiding urosonography to image urodynamic testing on patients with neurogenic bladder.
Other Names:
  • Urodynamics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bladder shape and morphology
Time Frame: Procedure (At time of urodynamic investigation)
Comparison of previous fluroscopy images and ceVUS images
Procedure (At time of urodynamic investigation)
Bladder neck configuration
Time Frame: Procedure (At time of urodynamic investigation)
Comparison of previous fluroscopy images and ceVUS images
Procedure (At time of urodynamic investigation)
Structure of urethra
Time Frame: Procedure (At time of urodynamic investigation)
Comparison of previous fluroscopy images and ceVUS images
Procedure (At time of urodynamic investigation)
Presence and degree of VUR
Time Frame: Procedure (At time of urodynamic investigation)
Comparison of previous fluroscopy images and ceVUS images
Procedure (At time of urodynamic investigation)
Images of active voiding
Time Frame: Procedure (At time of urodynamic investigation)
Comparison of previous fluroscopy images and ceVUS images
Procedure (At time of urodynamic investigation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient/caregiver preference
Time Frame: Immediately following urodynamic investigation or up to 7 days after by phone
Comparison survey
Immediately following urodynamic investigation or up to 7 days after by phone

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nora G Kern, MD, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2021

Primary Completion (Anticipated)

March 2, 2022

Study Completion (Anticipated)

March 2, 2022

Study Registration Dates

First Submitted

February 1, 2021

First Submitted That Met QC Criteria

February 3, 2021

First Posted (Actual)

February 4, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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