DEXTRANOMER BEADS IN STABILIZED NON-ANIMAL SODIUM HYALURONATE GEL (NASHA^TM/Dx GEL) FOR VESICOURETERAL REFLUX: MULTI-CENTER STUDY IN JAPANEASE PATIENTS

Abstract

(Purpose) To investigate the efficacy and safety of endoscopic treatment with the injectable gel of dextranomer beads in stabilized non-animal sodium hyaluronate (NASHA^TM/Dx gel) administered submucosally close to the proximity of ureteral orifice, we performed the multi-center open study of Japanese patients with vesicoureteral reflux (VUR). We herein report the results of the study.
(Subjects and methods) Patients aged ≥1 year with grade II-IV VUR underwent endoscopic injection with NASHA/Dx gel. Post-treatment assessment was done by voiding cystourethrography (VCUG) at 3 and 12 months. Patients with VUR grade II-IV at 3 months underwent re-treatment, with VCUG assessment 3 and 12 months after re-treatment. Positive response to treatment was defined as reflux grade 0 or I.
(Results) The initial treatment was conducted to 116 ureters in 73 patients. The per-protocol efficacy population included 97 ureters in 71 patients. On a per-ureter basis, the positive response rate at 12 months after the last endoscopic treatment was 69.1%, compared with 62.0% on a per-patient basis. Improvement in reflux grade was shown to be statistically significant at both 3 months post initial treatment and 12 months post last treatment. Positive response rate decreased with increasing baseline reflux grade. There were only two mild adverse events (AEs) and one moderate laboratory fluctuation which were potentially relating to NASHA/Dx gel.
(Conclusions) This study has shown that endoscopic injection of NASHA/Dx gel is effective and well tolerated in Japanese patients with VUR. First-line use of this treatment for VUR could potentially be considered for Japan also.