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

Background: The "difficult ureter" specifically denotes narrow and tortuous ureters typically requiring two-stage surgery. We firstly proposed combining a visible ureteral dilation balloon catheter with holmium laser for treating 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 minutes (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 ￥7800yuan 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 efficacy and safe strategy for treatment of ureteral calculi in patients with ureteral stricture. Moreover, the total hospital stays, total operation time, and costs were largely decreased by DVBD+FUS treatment.

S. Karger AG, Basel
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2025
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