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Efficacy of Contrast Enhanced Voiding Urosonography for Urodynamic Studies

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ClinicalTrials.gov Identifier: NCT04738539
Recruitment Status : Recruiting
First Posted : February 4, 2021
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Nora Kern, MD, University of Virginia

Study Description
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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
Myelomeningocele Neurogenic Bladder Tethered Cord Syndrome Bladder, Neurogenic Urologic Diseases Neurologic Dysfunction Drug: Contrast Enhanced Voiding Urosonography with Urodynamic Testing Diagnostic Test: Urodynamic Testing

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 Design
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Study Type : Observational
Estimated Enrollment : 105 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of Contrast Enhanced Voiding Urosonography for Urodynamic Studies
Actual Study Start Date : March 2, 2021
Estimated Primary Completion Date : March 2, 2022
Estimated Study Completion Date : March 2, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.
 Drug: Contrast Enhanced Voiding Urosonography with Urodynamic 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

Diagnostic Test: Urodynamic Testing
We will be using contrast enhanced voiding urosonography to image urodynamic testing on patients with neurogenic bladder.
Other Name: Urodynamics


Outcome Measures
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Primary Outcome Measures :
  1. Bladder shape and morphology [ Time Frame: Procedure (At time of urodynamic investigation) ]
    Comparison of previous fluroscopy images and ceVUS images

  2. Bladder neck configuration [ Time Frame: Procedure (At time of urodynamic investigation) ]
    Comparison of previous fluroscopy images and ceVUS images

  3. Structure of urethra [ Time Frame: Procedure (At time of urodynamic investigation) ]
    Comparison of previous fluroscopy images and ceVUS images

  4. Presence and degree of VUR [ Time Frame: Procedure (At time of urodynamic investigation) ]
    Comparison of previous fluroscopy images and ceVUS images

  5. Images of active voiding [ Time Frame: Procedure (At time of urodynamic investigation) ]
    Comparison of previous fluroscopy images and ceVUS images


Secondary Outcome Measures :
  1. Patient/caregiver preference [ Time Frame: Immediately following urodynamic investigation or up to 7 days after by phone ]
    Comparison survey


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients presenting to UVA Pediatric Urology for follow up or repeat urodynamics study.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04738539


Contacts
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Contact: Susan V Leroy, MSN 434-924-0123 svg5m@virginia.edu
Contact: Nora G Kern, MD 434-924-0123 ngl2z@virginia.edu

Locations
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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22911
Contact: Susan Leroy, MSN    434-924-0123    svg5m@virginia.edu   
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Nora G Kern, MD University of Virginia
More Information
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Additional Information:

Publications:

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Responsible Party: Nora Kern, MD, Associate Professor, Department of Urology, University of Virginia
ClinicalTrials.gov Identifier: NCT04738539    
Other Study ID Numbers: HSR200346
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Nora Kern, MD, University of Virginia:
Contrast Enhanced Voiding Urosonography
Urodynamics
Neurogenic Bladder
Detrusor Sphincter Dyssynergia
Additional relevant MeSH terms:
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Urinary Bladder, Neurogenic
Meningomyelocele
Spina Bifida Cystica
Neural Tube Defects
Neurologic Manifestations
Urologic Diseases
 Nervous System Diseases
Urinary Bladder Diseases
Nervous System Malformations
Congenital Abnormalities
Spinal Dysraphism