Efficacy and Safety of a Novel <5 mm Ureteral Dilation Balloon Catheter in Holmium Laser Surgery for Ureteral Calculi with Physiological Narrowing: A Randomized Controlled Trial.

INTRODUCTION

The "difficult ureter" specifically denotes narrow and tortuous ureters typically requiring two-stage surgery. We first proposed combining a visible ureteral dilation balloon catheter with a holmium laser to treat ureteral calculi in patients with ureteral stenosis.

METHODS

A prospective, multicenter, randomized, open-label, and controlled study enrolled 60 ureteral calculi patients with ureteral stricture from July 2021 to July 2023. Patients were randomly assigned to either first-stage ureteroscopic lithotripsy with direct visualization balloon dilation (DVBD + FUS) or dilation using a scope and inner core (DUS + S). The primary outcome was the success of sheath placement at first-stage surgery, assessed by the secondary operation rate. Secondary outcomes included stone clearance rates, postoperative serum creatinine increase, decreased hemoglobin, total hospital stay, operation time, ureteral stent removal time, ureteral injury, and total surgery costs.

RESULTS

Sixty patients aged 24-68 were enrolled, with stone diameters ranging from 0.6 to 2 cm (average 1.4 cm). After first-stage surgeries, 17 (56.67%) in the DUS + S group and 4 (13.3%) in the DVBD + FUS group required secondary surgery (p < 0.001). The DVBD + FUS group had a significantly shorter hospital stay by 3.2 days (6.60 vs. 3.4 days, p < 0.001) and a shorter operation time by 11 min (p = 0.010). After 3 months, ureteral stent removal times were similar (28.1 ± 8.5 vs. 26.1 ± 6.3 days). Total costs were CNY 7,800 lower in the DVBD + FUS group (p < 0.001). Intraoperative and postoperative complications were comparable. Six-month follow-ups showed no hydronephrosis in either group.

CONCLUSION

Our study firstly indicated that DVBD + FUS could be an efficacious and safe strategy for treating ureteral calculi in patients with ureteral stricture. Moreover, DVBD + FUS treatment largely decreased total hospital stays, total operation time, and costs.