Proprietary non-animal stabilized hyaluronic acid/dextranomer gel (NASHA/Dx) for endoscopic treatment of grade IV vesicoureteral reflux: Long-term observational study

Abstract

Conclusions This study represents the longest published followup of Grade IV VUR patients undergoing endoscopic treatment. Three-quarters of patients did not need ureteral reimplantation. Optimal injection technique and higher injection volume were associated with a reduced ureteral reimplantation rate. Treatment with NASHA/Dx was durable and well tolerated: long-term risks of UTI, bladder dysfunction and recurrent VUR were low.

Non-Animal Stabilized Hyaluronic Acid/Dextranomer Gel (NASHA/Dx, Deflux) for Endoscopic Treatment of Vesicoureteral Reflux: What Have We Learned Over the Last 20 Years?

“…In the study with the longest follow-up (15−25 years), the only complications were late ureteral reimplantation (undertaken in five patients [2.7%], of whom two had obstructive refluxing megaureter at the time of NASHA/Dx treatment, which is now recognized as potentially rendering patients unsuitable for endoscopic injection), and calcification (one patient [0.5%]; discovered in a routine examination and did not require intervention). 19 There were no safety issues in the remaining 96.8% of patients in this study.…”

“…21,22,28 In each of 3 studies, 1 patient developed ureteral obstruction after NASHA/Dx treatment, representing incidence rates of 0.5%−1.3%. 19,20,27 Deterioration in renal function after NASHA/Dx treatment was observed in four renal units in 1 study. 30 However, the overall incidence of this was not defined (only patients with UTIs were assessed) and, despite apparent independence from VUR recurrence, it is possible that the observed deteriorations were caused by the disease rather than treatment with NASHA/Dx.…”

“…19,23,27,28,S42 Accordingly, in the long-term grade IV study with a reimplantation rate of 25%, the risk of late recurrence was low, with only 3% of patients requiring ureteral reimplantation >5 years after the last endoscopic injection. 19 In the studies included in our review, there were no reports that prior endoscopic treatment with NASHA/Dx complicated the ureteral reimplantation procedure. This reflects data from elsewhere, showing that ureteral reimplantation remains possible in case VUR persists after treatment with NASHA/Dx.…”

“…Factors associated with statistically significant reductions in treatment efficacy include high baseline grade of VUR, young age, early onset of reflux during bladder filling, high distal ureteral diameter ratio (UDR), renal scarring, bladder/bowel dysfunction (BBD), double ureters, bilateral VUR and recurrent UTIs. [19][20][21][22]24,27,28,30,31 Efficacy may be reduced in these groups, but not to levels compromising the viability of NASHA/Dx as high proportions of patients are still able to avoid open surgery. 1 study included in our review was conducted in 123 children with double ureters, and none of the patients required open surgery or had significant complications after NASHA/Dx treatment.…”

“…21,22,28 The highest reported rate of 25% was reported in the study with the longest follow-up (15−25 years); it was conducted in patients with baseline VUR grade IV, in whom a higher reimplantation rate vs patients with lower-grade VUR may be expected. 19 The authors noted that open surgery would have been recommended universally in their study population before endoscopic treatment Continued became available and that, at many centers, ureteral reimplantation remains standard of care in these patients due to a perception of limited effectiveness of endoscopic injection in high-grade VUR. Long-term results have disproven this concept and shown that, although reflux may recur within 2 years in a minority of patients with initially successful NASHA/Dx treatment, efficacy is likely to be maintained long-term among those with resolution lasting for 2 years.…”