PMID- 20715499
OWN - NLM
STAT- MEDLINE
DCOM- 20101007
LR  - 20221207
IS  - 0021-5287 (Print)
IS  - 0021-5287 (Linking)
VI  - 101
IP  - 5
DP  - 2010 Jul
TI  - [Dextranomer beads in stabilized non-animal sodium hyaluronate gel (NASHA/Dx gel) 
      for vesicoureteral reflux: multi-center study in Japanease patients].
PG  - 676-82
AB  - PURPOSE: To investigate the efficacy and safety of endoscopic treatment with the 
      injectable gel of dextranomer beads in stabilized non-animal sodium hyaluronate 
      (NASHA/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 > or = 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 retreatment. Positive response to treatment was defined as reflux grade 0 
      or 1. 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.
FAU - Tanikaze, Saburo
AU  - Tanikaze S
AD  - Department of Urology, Aichi Children's Health and Medical Center.
FAU - Osa, Yuichi
AU  - Osa Y
FAU - Tada, Minoru
AU  - Tada M
FAU - Goya, Nobuyuki
AU  - Goya N
FAU - Asanuma, Hiroshi
AU  - Asanuma H
FAU - Yamazaki, Yuichiro
AU  - Yamazaki Y
FAU - Shimada, Kenji
AU  - Shimada K
FAU - Sugita, Yoshifumi
AU  - Sugita Y
FAU - Goto, Takafumi
AU  - Goto T
FAU - Yamaguchi, Takanori
AU  - Yamaguchi T
LA  - jpn
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PL  - Japan
TA  - Nihon Hinyokika Gakkai Zasshi
JT  - Nihon Hinyokika Gakkai zasshi. The japanese journal of urology
JID - 2984841R
RN  - 0 (Dextrans)
RN  - 0 (Gels)
RN  - 30KXI0TVD3 (dextranomer)
RN  - 9004-61-9 (Hyaluronic Acid)
SB  - IM
MH  - Asian People
MH  - Child
MH  - Child, Preschool
MH  - Dextrans/*administration & dosage
MH  - Female
MH  - Gels
MH  - Humans
MH  - Hyaluronic Acid/*administration & dosage
MH  - Infant
MH  - Injections
MH  - Male
MH  - Ureter
MH  - Vesico-Ureteral Reflux/*therapy
EDAT- 2010/08/19 06:00
MHDA- 2010/10/12 06:00
CRDT- 2010/08/19 06:00
PHST- 2010/08/19 06:00 [entrez]
PHST- 2010/08/19 06:00 [pubmed]
PHST- 2010/10/12 06:00 [medline]
AID - 10.5980/jpnjurol.101.676 [doi]
PST - ppublish
SO  - Nihon Hinyokika Gakkai Zasshi. 2010 Jul;101(5):676-82. doi: 
      10.5980/jpnjurol.101.676.