Katherine Moore1, Stéphane Bolduc2. 1. Division of Urology, Department of Surgery, CHU de Québec, Université Laval, Quebec City, Quebec, Canada. Electronic address: katherine.moore.1@ulaval.ca. 2. Division of Urology, Department of Surgery, CHU de Québec, Université Laval, Quebec City, Quebec, Canada.
Abstract
PURPOSE: Endoscopic injection of a bulking agent is becoming a first-line treatment for low grade vesicoureteral reflux. We prospectively compared the efficacy of 2 such products commercially available in Canada. MATERIALS AND METHODS: A total of 275 patients with documented gradeI to V vesicoureteral reflux were prospectively enrolled in a comparative study between April 2005 and February 2011 to be randomly treated endoscopically with eitherpolydimethylsiloxane (Macroplastique®) or dextranomer/hyaluronic acid copolymer (Deflux®). Of the ureters 202 were treated with polydimethylsiloxane and 197 with dextranomer/hyaluronic acid copolymer. Patients were followed with voiding cystourethrography at 3 months and renal ultrasonography at 3 months and at 1 year. Median followup was 4.3 years. The primary outcome was surgical success (resolution vs nonresolution), and secondary outcomes included occurrence of adverse events. RESULTS:Vesicoureteral reflux was fully corrected in 182 of 202 ureters (90%) treated with polydimethylsiloxane, compared to 159 of 197 (81%) treated with dextranomer/hyaluronic acid copolymer (p <0.05). Obstruction was found in 5 ureters. Univariate and multivariate analyses did not allow identification of any characteristics that could explain the significant difference in the success rates except for the type of product used. CONCLUSIONS: We present the largest known prospective evaluation comparing 2 bulking agents for the treatment of vesicoureteral reflux. Endoscopic injection of polydimethylsiloxane resulted in a better success rate than dextranomer/hyaluronic acid copolymer. The rate of resolution obtained with the latter is lower than those previously published due to the inclusion of high grade reflux.
RCT Entities:
PURPOSE: Endoscopic injection of a bulking agent is becoming a first-line treatment for low grade vesicoureteral reflux. We prospectively compared the efficacy of 2 such products commercially available in Canada. MATERIALS AND METHODS: A total of 275 patients with documented grade I to V vesicoureteral reflux were prospectively enrolled in a comparative study between April 2005 and February 2011 to be randomly treated endoscopically with either polydimethylsiloxane (Macroplastique®) or dextranomer/hyaluronic acid copolymer (Deflux®). Of the ureters 202 were treated with polydimethylsiloxane and 197 with dextranomer/hyaluronic acid copolymer. Patients were followed with voiding cystourethrography at 3 months and renal ultrasonography at 3 months and at 1 year. Median followup was 4.3 years. The primary outcome was surgical success (resolution vs nonresolution), and secondary outcomes included occurrence of adverse events. RESULTS: Vesicoureteral reflux was fully corrected in 182 of 202 ureters (90%) treated with polydimethylsiloxane, compared to 159 of 197 (81%) treated with dextranomer/hyaluronic acid copolymer (p <0.05). Obstruction was found in 5 ureters. Univariate and multivariate analyses did not allow identification of any characteristics that could explain the significant difference in the success rates except for the type of product used. CONCLUSIONS: We present the largest known prospective evaluation comparing 2 bulking agents for the treatment of vesicoureteral reflux. Endoscopic injection of polydimethylsiloxane resulted in a better success rate than dextranomer/hyaluronic acid copolymer. The rate of resolution obtained with the latter is lower than those previously published due to the inclusion of high grade reflux.