Dextranomer/hyaluronic acid copolymer (defluxρ) injection for vesicoureteral reflux in children: The efficacy and safety

Abstract

Purpose: We evaluated the efficacy and safety of Deflux injection for treating vesicoureteral reflux (VUR) in children. Materials and Methods: Between January 2004 and May 2006, 49 children (28 boys and 21 girls) with a mean age of 51 months (5-182) underwent Deflux injection. VUR was unilateral in 19 cases (38.8%) and bilateral in 30 (61.2%), affecting 79 ureters. VUR was grades II to V in 26 cases (32.9%), 24 (30.4%), 16 (20.3%), and 4 (5.1%), respectively. Our clinical protocol involved ultrasonography at 6 weeks to evaluate the development of hydronephrosis and the creation of submucosal mound, and VCUG or RIVCU at 3 months to assess the VUR. Results: The median follow-up was 8.0 months (1-22). The cure rate at 3 months by the ureter was 81.6% (88.9% for grade I, 100% for grade II, 79.2% for grade III, 75.0% for grade IV, and 50.0% for grade V) and the cure rate was 84.8% for the total patients (100% for the unilateral cases and 80% for the bilateral cases). There were 16 patients with 1 year of follow-up and the cure rate was 88.5% by the ureter and 87.5% for the total patient. The severity of VUR (p=0.035) and the concomitant voiding dysfunction (p=0.001) were the significant predictors of a successful outcome. One patient complained of gross hematuria resolved within a few days. Conclusions: Deflux injection was safe and efficacious with a low complication rate. The severity of VUR and the concomitant voiding dysfunction had significant adverse effects on the cure rate.