Efficacy of Contrast Enhanced Voiding Urosonography for Urodynamic Studies
Study Details
Study Description
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 | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | 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:
Diagnostic Test: Urodynamic Testing
We will be using contrast enhanced voiding urosonography to image urodynamic testing on patients with neurogenic bladder.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Bladder shape and morphology [Procedure (At time of urodynamic investigation)]
Comparison of previous fluroscopy images and ceVUS images
- Bladder neck configuration [Procedure (At time of urodynamic investigation)]
Comparison of previous fluroscopy images and ceVUS images
- Structure of urethra [Procedure (At time of urodynamic investigation)]
Comparison of previous fluroscopy images and ceVUS images
- Presence and degree of VUR [Procedure (At time of urodynamic investigation)]
Comparison of previous fluroscopy images and ceVUS images
- Images of active voiding [Procedure (At time of urodynamic investigation)]
Comparison of previous fluroscopy images and ceVUS images
Secondary Outcome Measures
- Patient/caregiver preference [Immediately following urodynamic investigation or up to 7 days after by phone]
Comparison survey
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 0-17
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Must have had prior urodynamic study at UVA
Exclusion Criteria:
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Pregnant women (self-reported)
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Fetuses
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Neonates
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Prisoners
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Subjects with preexisting cardiac conditions (such as CHF and ventricular arrhythmias)
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Subjects with a known hypersensitivity to Lumason
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Virginia | Charlottesville | Virginia | United States | 22911 |
Sponsors and Collaborators
- University of Virginia
Investigators
- Principal Investigator: Nora G Kern, MD, University of Virginia
Study Documents (Full-Text)
None provided.More Information
Additional Information:
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.
- HSR200346