Long-Term Clinical Outcomes and Parental Satisfaction After Dextranomer/Hyaluronic Acid (Dx/HA) Injection for Primary Vesicoureteral Reflux

Abstract

Purpose: Endoscopic dextranomer/hyaluronic acid (Dx/HA) injection is a common treatment for vesicoureteral reflux (VUR) with excellent reported short-term clinical success rates. Long-term outcomes are less well-defined. We assessed long-term outcomes and parental satisfaction after Dx/HA injection for primary VUR with >5-year follow-up.Materials and Methods: Families of all patients who underwent Dx/HA injection for primary VUR at our institution between 2008 and 2012 were contacted for telephone interview. Data collected by phone included parental satisfaction and presence and severity of UTIs pre-operatively and post-operatively. Patient demographics, radiographic VUR data, need for secondary surgery, and surgical indications were obtained through chart review.Results: Five hundred and seventy-five patients underwent Dx/HA injection for primary VUR between 2008 and 2012. Ninety-nine (17.2%) of these patients' parents were successfully contacted and interviewed. Median follow-up time from surgery to survey was 8.4 (IQR 6.8–9.6) years. Secondary surgery was performed in 13/99 (13.1%), most commonly repeat Dx/HA injection. Seven patients (7.1%) underwent secondary Dx/HA injection for persistent VUR without UTIs at a median of 0.35 (IQR 0.33–0.77) years post-operatively. Five patients (5.1%) underwent Dx/HA injection (n = 3) or ureteral reimplantation (n = 2) for VUR with febrile UTIs (fUTIs) at a median of 2.2 (IQR 1.3–5.1) years. One patient had ureteral reimplantation for symptomatic obstruction 2.8 years after initial surgery. Only 3/99 (3.0%) required open or laparoscopic surgery after Dx/HA injection. Eighty-three families (84.7%) reported ≥1 fUTIs pre-operatively. Of these, only 9/83 (10.8%) reported fUTIs post-operatively, for an overall clinical success rate of 89.2%. Clinical success was 93.1% in patients whose pre-operative fUTIs were treated outpatient and 80.0% in those hospitalized at least once for fUTI treatment pre-operatively. Ninety-four percent of parents were highly satisfied, 2.4% partially satisfied, and 3.5% dissatisfied.Conclusions: Endoscopic injection with Dx/HA for primary VUR appears to have good long-term clinical success rates and high parental satisfaction, mirroring our previously reported short-term results. Post-operative ureteral obstruction is rare but may occur years post-operatively, justifying initial sonographic surveillance, and repeat imaging in symptomatic patients.

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?

“…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.…”

“…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.…”

“…26 2 studies selected in our review examined fUTIs during followup by pretreatment VUR grade (Table 2). 26,27 1 of these only included patients with grade III or IV VUR, while the other included all five grades. In both cases, pretreatment VUR grade had no significant effect on the risk of a fUTI.…”

Evolving surgical management of pediatric vesicoureteral reflux: is open ureteral reimplantation still the ‘Gold Standard’?

“…In a series of 229 children undergoing EI with Dx/ HA, 14 patients (6.3%) experienced a postoperative febrile UTI during mean clinical follow-up of 34.7 months (33). In a longer-term study with greater than 5-year (median 8.4 year) follow-up, a 10.2% incidence of postoperative febrile UTI was reported (40). These studies underscore the long--term clinical success rate of Double HIT for primary VUR.…”

“…Open ureteral reimplantation (OUR), robot--assisted laparoscopic extravesical reimplantation (RALUR), and endoscopic injection (EI) have all proven effective at correcting VUR and preventing febrile urinary tract infections (7,8). Defining "success" postoperatively is key to comparing the outcomes of each surgical procedure and analyzing available literature.…”