Long-term followup of children treated with dextranomer/hyaluronic acid copolymer for vesicoureteral reflux.

PURPOSE: Dextranomer/hyaluronic acid copolymer is a novel substance that has favorable properties for endoscopic treatment of vesicoureteral reflux. We assess the long-term efficacy and safety of this treatment of children.

MATERIALS AND METHODS: Children 1 to 15 years old with grade III or greater vesicoureteral reflux were eligible for enrollment in our study. All patients received endoscopic treatment with dextranomer/hyaluronic acid copolymer and were scheduled to have a voiding cystourethrogram 3 and 12 months after implantation. Children with reflux grade III or greater after treatment received up to 2 more implantations, and those with persistent reflux were referred for open surgery. In some cases long-term clinical followup was accompanied by a late voiding cystourethrogram.

RESULTS: A total of 228 patients received endoscopic treatment. The efficacy population was comprised of 221 children, including 67 who received 2 and 8 who received 3 implantations. Endoscopic treatment was performed without complications in all cases. Patients were followed clinically for 2 to 7.5 years (mean 5). On the last voiding cystourethrogram 68% of patients had a positive response (grade I or less) and 81% had no dilating reflux. The corresponding results for treated ureters were 75% and 85%, respectively. Only 27 (12%) patients were referred for open surgery. A late voiding cystourethrogram was performed in 49 patients 2 to 5 years after treatment. Of the ureters free of reflux (grade 0) 3 to 12 months after treatment 96% remained free of dilating reflux. Adverse events occurred in association with implantation in only 2% of patients, although urinary tract infection subsequently developed in 8%.

CONCLUSIONS: Endoscopic treatment with dextranomer/hyaluronic acid copolymer was effective and well tolerated in children with vesicoureteral reflux. Long-term followup indicated that there was no deterioration in patients responding positively to treatment.