OBJECTIVES:Dextranomer/hyaluronic acid (Dx/HA) copolymer has favorable properties for endoscopic treatment of vesico-ureteral reflux (VUR). This open, randomized study was performed to compare the efficacy and safety of Dx/HA copolymer with antibiotic prophylaxis in children with VUR. METHODS:Children >1 year of age with VUR grade II to IV (confirmed by voiding cysto-urethrogram) receivedendoscopic treatment with Dx/HA copolymer (n = 40) or 12 months of antibiotic prophylaxis (n = 21). Patients in the latter group with reflux grade >or=II at month 3 received a second implantation. All patients were reassessed by voiding cysto-urethrogram at month 12. Scintigraphy and ultrasound were performed to investigate renal status. RESULTS: At month 12, 69% of patients in the Dx/HA copolymer group had reflux grade <or=I bilaterally, compared with 38% in the antibiotic group (P =.029). Of patients with reflux grade <or=I at month 3, 89% showed a sustained response at month 12. One serious adverse event was reported in the antibiotic prophylaxis group, but this was not attributed to study treatment. No other adverse events occurred. CONCLUSIONS:Endoscopic treatment with Dx/HA copolymer was more effective than antibiotic prophylaxis in alleviating childhood VUR, and there were no safety concerns with either treatment.
RCT Entities:
OBJECTIVES:Dextranomer/hyaluronic acid (Dx/HA) copolymer has favorable properties for endoscopic treatment of vesico-ureteral reflux (VUR). This open, randomized study was performed to compare the efficacy and safety of Dx/HA copolymer with antibiotic prophylaxis in children with VUR. METHODS:Children >1 year of age with VUR grade II to IV (confirmed by voiding cysto-urethrogram) received endoscopic treatment with Dx/HA copolymer (n = 40) or 12 months of antibiotic prophylaxis (n = 21). Patients in the latter group with reflux grade >or=II at month 3 received a second implantation. All patients were reassessed by voiding cysto-urethrogram at month 12. Scintigraphy and ultrasound were performed to investigate renal status. RESULTS: At month 12, 69% of patients in the Dx/HA copolymer group had reflux grade <or=I bilaterally, compared with 38% in the antibiotic group (P =.029). Of patients with reflux grade <or=I at month 3, 89% showed a sustained response at month 12. One serious adverse event was reported in the antibiotic prophylaxis group, but this was not attributed to study treatment. No other adverse events occurred. CONCLUSIONS: Endoscopic treatment with Dx/HA copolymer was more effective than antibiotic prophylaxis in alleviating childhood VUR, and there were no safety concerns with either treatment.
Authors: John David Spencer; Andrew Schwaderer; Kirk McHugh; Brian Vanderbrink; Brian Becknell; David S Hains Journal: Pediatr Nephrol Date: 2011-05-10 Impact factor: 3.714
Authors: Jalal Bakhtiari; Abdol Mohammad Kajbafzadeh; Mahdi Marjani; Abbas Veshkini; Azin Tavakoli; Mohammad Javad Gharagozlou; Amir Niasari-Naslaji Journal: BMC Res Notes Date: 2011-01-22