- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04738539
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
Status
Recruiting
Conditions
Intervention / Treatment
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
- Name: Susan V Leroy, MSN
- Phone Number: 434-924-0123
- Email: svg5m@virginia.edu
Study Contact Backup
- Name: Nora G Kern, MD
- Phone Number: 434-924-0123
- Email: ngl2z@virginia.edu
Study Locations
-
-
Virginia
-
Charlottesville, Virginia, United States, 22911
- Recruiting
- University of Virginia
-
Contact:
- Susan Leroy, MSN
- Phone Number: 434-924-0123
- Email: svg5m@virginia.edu
-
-
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:
We will be using contrast enhanced voiding urosonography to image urodynamic testing on patients with neurogenic bladder.
Other Names:
|
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.
Sponsor
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.
General Publications
- Drzewiecki BA, Bauer SB. Urodynamic testing in children: indications, technique, interpretation and significance. J Urol. 2011 Oct;186(4):1190-7. doi: 10.1016/j.juro.2011.02.2692. Epub 2011 Aug 16. Review.
- Fernbach SK, Feinstein KA, Schmidt MB. Pediatric voiding cystourethrography: a pictorial guide. Radiographics. 2000 Jan-Feb;20(1):155-68; discussion 168-71. Review.
- Mane N, Sharma A, Patil A, Gadekar C, Andankar M, Pathak H. Comparison of contrast-enhanced voiding urosonography with voiding cystourethrography in pediatric vesicoureteral reflux. Turk J Urol. 2018 May;44(3):261-267. doi: 10.5152/tud.2018.76702. Epub 2018 Mar 6.
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSR200346
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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