Diagnosis of vesicoureteric reflux with contrast ultrasound: Comparison to voiding cystourethrography
Kassa Darge, MD, PhD, Aikaterini Ntoulia, MD, PhD, Susan J. Back, MD, Laura Poznick, RDMS, AAU, Richard Bellah, MD, Douglas Canning, MD.
The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Introduction: Contrast enhanced voiding urosonography (ceVUS) is a sensitive and safe method for detection of vesicoureteric reflux (VUR). The most widely used US contrast agent for ceVUS was not available in the U.S. The existing US contrast agent Optison® had not yet been evaluated for use in ceVUS. The aim of this study was to compare ceVUS with the intravesical administration of Optison® with fluoroscopic VCUG regarding diagnostic efficacy and safety.
Methods & Materials: A prospective comparative study between ceVUS and VCUG was carried out under an investigational new drug (IND) authorization by the Food and Drug Administration of the U.S. (FDA) and after obtaining institutional IND and IRB approvals. The patients were referred from urology for clinically indicated VCUG. A written informed consent signed by both parents/guardians was obtained. Safety assessment included physical examination and monitoring of the heart rate and pO2 before, during and after the study. A 48-hour phone follow-up was carried out using a standardized questionnaire. After bladder catheterization ceVUS was performed with an infusion of a 0.1%-0.5% suspension of the US contrast agent in normal saline. Contrast specific low MI US scan modality was used to evaluate the bladder and kidneys during bladder filling and emptying. Vesicoureteric reflux (VUR) was diagnosed when microbubbles were detected in a ureter or pelvicalyx. A standard VCUG followed at the end of the ceVUS.
Results: 31 patients were recruited and 1 excluded as it required sedation after enrollment. The remaining 30 patients, 21 females and 9 males with a mean age of 3.5 years (0.1-17.0 years) completed the study. The indications for reflux study were urinary tract infection 18 (60%), follow-up of known VUR 6 (20%), antenatal urinary tract dilation 3 (10%), dysplastic kidney 2 (6.7%) and voiding dysfunction 1 (3.3%). The safety monitoring at the time of the examination was normal in all cases. On the 48-hour follow-up 1 (3.3%) of the patients had a minor adverse event, a transient dysuria, most likely due to the catheterization. The 30 patients had a total of 62 pelvi-ureteric units. Taking the VUR depicted in ceVUS and/or VCUG as the reference standard the sensitivity of ceVUS and VCUG was equal at 92.3%. The comparison of the grades of VUR was discrepant in 3/13 positive pelvi-ureteric units.
Conclusions: The intravesical use of the US contrast agent Optison® for ceVUS in children is safe. The comparison of ceVUS with VCUG lead to comparable results. Thus ceVUS with Optison can replace VCUG in routine practice.
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