A multicenter clinical trial investigating the use of a fluoroscopically controlled cutting balloon catheter for the management of ureteral and ureteropelvic junction obstruction

Purpose: We assessed the efficacy of a fluoroscopically controlled cutting balloon catheter for the treatment of ureteropelvic junction and ureteral strictures. Materials and Methods: A multicenter trial was performed that included 66 endopyelotomies and 49 endoureterotomies. To our knowledge this study represents the largest number of patients with ureteropelvic junction obstruction and ureteral strictures tested with this device to date. Results: With a mean followup of 7.8 months (range 1 to 17.9) the patency rate was 77% for endopyelotomy, with 72% of the primary and 100% of the secondary ureteropelvic junction obstructions remaining patent. The endoureterotomy patients were followed for an average of 8.7 months (range 1.2 to 17.0), with a patency rate of 55%. Conclusions: A cutting balloon endoscopic incision is effective in the majority of cases, with patency rates for endopyelotomies and endoureterotomies that mirror current endourological reports using other, albeit more time intensive and more invasive, incisional techniques.