Evaluation of a New Design of Antireflux-biodegradable Ureteral Stent in Animal Model.

OBJECTIVE: To determine the effects in urinary tract of a new antireflux-biodegradable ureteral stent.

MATERIALS AND METHODS: Thirty six ureters belonging to 24 pigs were used. The study began with endoscopic, nephrosonographic, and fluoroscopic assessments. Three study groups of ureters (n = 12) were then specified. In group I, a biodegradable antireflux ureteral stent (BDG-ARS) was inserted in the right ureter of 12 pigs. Group II comprised the left ureter of the same animals, in which a double-pigtail stent was placed for 6 weeks. Group III ureters, belonging to 12 additional animals, were subjected to a ureteropelvic junction obstruction model that was then treated by endopyelotomy and stenting with BDG-ARS. Follow-ups were performed at 3-6 weeks and at 5 months.

RESULTS: None of the ureters receiving the BDG-ARS showed any evidence of vesicoureteral reflux (VUR). BDG-ARS degradation took place in a controlled and predictable fashion from the third to the sixth weeks, and no obstructive fragments appeared. No differences were found between groups I and II regarding passive ureteral dilation, but significant differences were found regarding VUR and ureteral orifice damage. BDG-ARS always maintained distal ureteral peristalsis. BDG-ARS in group III showed a 50% positive urine culture rate and a 16.6% migration rate in both BDG-ARS groups.

CONCLUSION: BDG-ARS avoided VUR and bladder trigone irritation. In addition, this polymer combination and stent-braided design achieved a consistent biodegradation rate with no obstructive fragments and with uniform degradation between the third and the sixth weeks. Consequently, morbidity associated with ureteral stents might be reduced.