Results of a 2-year multicenter trial of endoscopic treatment of vesicoureteral reflux with synthetic calcium hydroxyapatite. J Urol 2006 Jan;175(1):288-91
Date
01/13/2006Pubmed ID
16406928DOI
10.1016/S0022-5347(05)00013-3Scopus ID
2-s2.0-29144444322 (requires institutional sign-in at Scopus site) 29 CitationsAbstract
PURPOSE: With no FDA approved material available for endoscopic treatment of vesicoureteral reflux, in 2001 we began a prospective multicenter trial of synthetic calcium hydroxyapatite as a subureteral bulking agent in children with traditional indications for surgical repair.
MATERIALS AND METHODS: A total of 98 patients (155 ureters) with grades II to IV reflux were enrolled at 10 sites in the United States to obtain 86 patients with completed protocol end points at 3 months. Of the 86 patients 74 underwent renal and bladder ultrasonography, blood count and serum chemistry analysis, and VCUG at 1 year. A total of 46 patients (47%) completed 2-year study end points, including VCUG.
RESULTS: At 1 and 2 years 24 of the 74 patients (32%) were cured. Ureteral cure rates were 46% and 40% at 1 and 2 years, respectively. With 35 patients treated and 85% compliance with the required 2-year VCUG the primary center achieved 2-year cure rates of 66% of patients and 72% of ureters.
CONCLUSIONS: Synthetic calcium hydroxyapatite is a safe, durable and effective material for endoscopic treatment of VUR. Increased experience with the injection of synthetic calcium hydroxyapatite yields improved results.
Author List
Mevorach RA, Hulbert WC, Rabinowitz R, Kennedy WA, Kogan BA, Kryger JV, Caldamone A, Clark WR, Kaplan GW, Durkee CT, Elder JSAuthor
John V. Kryger MD Chief, Professor in the Urologic Surgery department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AdolescentAdult
Biocompatible Materials
Child
Clinical Protocols
Combined Modality Therapy
Cystoscopy
Durapatite
Female
Humans
Male
Prospective Studies
Time Factors
Ureteroscopy
Vesico-Ureteral Reflux
