Efficacy of Contrast Enhanced Voiding Urosonography for Urodynamic Studies

Study Overview
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Brief Summary
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The investigators will assess the feasibility of replacing fluoroscopy/iodinated contrast with ultrasound/sulfur hexafluoride lipid-type A microspheres during routine urodynamic studies.

Detailed Description
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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.

Official Title
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Efficacy of Contrast Enhanced Voiding Urosonography for Urodynamic Studies

Conditions
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Myelomeningocele, Neurogenic Bladder, Tethered Cord Syndrome, Bladder, Neurogenic, Urologic Diseases, Neurologic Dysfunction

Intervention / Treatment
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* Drug: Contrast Enhanced Voiding Urosonography with Urodynamic Testing
* Diagnostic Test: Urodynamic Testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with or being evaluated for neurogenic bladder<br>Pediatric patients presenting to UVA Pediatric Urology for follow up or repeat urodynamics testing. | Drug: Contrast Enhanced Voiding Urosonography with Urodynamic Testing<br>* We will be using contrast enhanced voiding urosonography to image urodynamic testing on patients with neurogenic bladder.<br>* Other names: Contrast Enhanced Voiding Urosonography;Diagnostic Test: Urodynamic Testing<br>* We will be using contrast enhanced voiding urosonography to image urodynamic testing on patients with neurogenic bladder.<br>* Other names: Urodynamics;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bladder shape and morphology | Comparison of previous fluroscopy images and ceVUS images | Procedure (At time of urodynamic investigation) | 
| Bladder neck configuration | Comparison of previous fluroscopy images and ceVUS images | Procedure (At time of urodynamic investigation) | 
| Structure of urethra | Comparison of previous fluroscopy images and ceVUS images | Procedure (At time of urodynamic investigation) | 
| Presence and degree of VUR | Comparison of previous fluroscopy images and ceVUS images | Procedure (At time of urodynamic investigation) | 
| Images of active voiding | 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 | Comparison survey | Immediately following urodynamic investigation or up to 7 days after by phone | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contrast Enhanced Voiding Urosonography, Urodynamics, Neurogenic Bladder, Detrusor Sphincter Dyssynergia