Comparison of Endoscopic Injection of Vantris and Gil-Vernet surgery in the Treatment of Primary Vesicoureteral Reflux (VUR)

Abstract

Purpose: Vesicoureteral Reflux (VUR) is the most common urologic condition in pediatric population, affecting almost 1% of children. The present study aims to compare outcomes of an open surgical technique (Gil-Vernet), an old-fashioned method still performed in some centers, and the endoscopic correction using Vantris as a preferred less invasive method in children with VUR. Materials and methods: In this randomized clinical trial, a total of 61 children with VUR of grades I-IV underwent either open surgical repair using the Gil-Vernet approach (30 patients, 50 renal refluxing units), or endoscopic repair using Vantris as the bulking agent (31 patients, 49 renal refluxing units). The change in VUR grade before and after operation was compared between the two groups. Results: The Vantris group comprised 5 males and 26 females with the mean age of 6.15±2.26 years (range, 1-10) versus the Gil-Vernet that included 9 males and 21 females with the mean age of 5.23±2.05 years (range, 1-10) (p=0.20 and 0.21, respectively). The VUR grade decreased significantly in both groups after operation (p<0.001), but despite a better improvement in the Vantris patients the inter-group analysis missed a statistically significant level in a marginal fashion (p=0.07). The rate of improvement and full improvement was 98% and 81.6% in the Vantris group vs. 94% and 86% in the Gil-Vernet group, respectively (p=0.62 and 0.56, respectively). Conclusion: Although postoperative improvement in VUR grade was better in the Vantris® group than that in the Gil-Vernet group, the difference was not statistically significant. Both methods of treatment were safe and with a high rate of success. Nevertheless, lesser manipulations performed in Vantris® makes it favorable comparing with open Gil-Vernet method. Citation: Rashed FK, Roshandel MR, Aghaei Badr T, Motlagh RS. Comparison of Endoscopic Injection of Vantris and Gil-Vernet surgery in the Treatment of Primary Vesicoureteral Reflux (VUR). J Urol Nephrol. 2019;6(1): 5. J Urol Nephrol 6(1): 5 (2019) Page 02 ISSN: 2380-0585 malformation, including obstruction or full duplicated pielocalicial system, suspected or proven voiding dysfunction through clinical findings, including abnormal neurological examination or intestinal dysfunction or obstructive-stimulatory LUTS, confirmed by VCUG or sonographic evidence of irregular bladder wall or diverticulum or trabeculation, low bladder volume and neurogenic bladder. 61 patients (100 renal units) with Vesicoureteral reflux were included based on pre-determined inclusion and exclusion criteria, after proving their reflux and the disease grade by VCUG. After explaining the study terms and conditions, the children were categorized into one of the groups of Vantris endoscopic injection (Promedone, Cordoba, Argentina) or Gil-Vernet open surgery. All operations were done by a single attending pediatric urologist who was trained with more than 10 years of performing experience for endoscopic injection. In patients undergoing endoscopic injection (31 patients, 50 renalunits), the Vantris bulking material was sub mucosally injected through the compact cystoscope with 6-French size and 23-gauge needles under the intramural ureter at 6 o’clock position of the ureteral orifice (STING method). In patients with higher grades of reflux and very loose ureteral orifice, it was injected inside the ureter. Volume of injection varied from 0.2 to about 2 cc, depending on the patient. The patients were discharged the same day of surgery with oral antibiotics for a week. Finally, follow-up was not feasible on one renal unit because Left the trial after surgery and 49 renal units were investigated in this group. In the Gil-Vernet antireflux surgery group (30 patients, 50 renal units), patients underwent classic Gil-Vernet antireflux surgery. In this technique, in cases of unilateral reflux, both sides underwent surgery to prevent reflux in the opposite side due to trigone instability. These patients were discharged after two days. Patients had no Foley catheter after surgery and were discharged with antibiotics for one week. All patients underwent ultrasonography two weeks after surgery for hydronephrosis (as a complication). Three months postoperatively, VCUG (voiding cysto-ureterography) was performed to follow-up of reflux. The reporters of the VCUG images were unaware of the type of the treatment. Treatment success was defined as eliminating or reducing the severity of reflux. Statistical analysis The data was reported by mean±standard deviation, or standard error (if necessary), and frequency (%). Statistical software SPSSTM Variable Vantris (31 cases) Open surgery (30 cases) P Value*