Results of a 2-year multicenter trial of endoscopic treatment of vesicoureteral reflux with synthetic calcium hydroxyapatite.
OBJECTIVE
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.


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.
Mevorach
Robert A
RA
University of Rochester, Rochester, New York, USA. Robert_mevorach@urmc.rochester.edu
Hulbert
William C
WC
Rabinowitz
Ronald
R
Kennedy
William A
WA
Kogan
Barry A
BA
Kryger
John V
JV
Caldamone
Anthony
A
Clark
William R
WR
Kaplan
George W
GW
Durkee
Charles T
CT
Elder
Jack S
JS
D000293:Adolescent; D000328:Adult; D001672:Biocompatible Materials; D002648:Child; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D003558:Cystoscopy; D017886:Durapatite; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D013997:Time Factors; D018666:Ureteroscopy; D014718:Vesico-Ureteral Reflux / Q000628:therapy*
D001672:Biocompatible Materials; D017886:Durapatite