Objectives: This study aims to assess the safety and efficacy of INNOVEXTM ureteral dilation balloon catheter to promote the likelihood of passing the ureter to complete primary ureteroscopy (URS). Methods: This was a prospective case series of patients during URS between August 2018 and January 2020 at the Pudong New District People’s Hospital. A 12-Fr INNOVEXTM ureteral dilation balloon catheter was used to dilate the ureter when a 5° Wolf 6.0/7.5-Fr ureteroscope encounters an unpredictable hindrance to retrograde access for ureteral stones. Patients with documented ureteral strictures, radiation therapy, or urothelial cancer were excluded from the analysis. The primary outcomes were to characterize the use, safety, and efficacy of ureteral dilation balloon catheter to promote stone treatment during URS. Results: Eight hundred and sixty-two patients underwent primary URS of ureteral stones over the study period. The use of a ureteral dilation balloon catheter to promote ureteral access was performed in 65 (7.54%) cases and effectively allowed completion of the procedure in 58 (89.23%) cases. No ureteral perforation and access loss occurred during the operation. Seven patients required ureteral stent placement for passive ureteral dilation, with definitive stone treatment later. Postoperative radiographic follow-up was available for 63 (96.92%) cases, and no ureteral stenosis was observed after balloon dilation. Conclusion: The use of a new ureteral dilation balloon catheter before endoscopic treatment of ureteral stones was associated with a high success rate and few complications. The convenient use method under direct vision at the whole process may increase the willingness of doctors to use it. In addition, it may reduce the need for secondary procedures for patients undergoing URS to manage ureteral stones.

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