Abstract
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.
Plain Language Summary
At present, more and more people are suffering from renal ureteral calculi. Clinically, conventional ureteroscopic lithotripsy is generally used for treatment. However, this method has certain defects due to the need for fluoroscopy, contrast agent positioning, and other issues. Moreover, the probability of surgical failure caused by tortuous and narrow ureters is 8–20%. In this study, for patients with ureteral stricture, an innovative technology has been invented, aiming to improve the effectiveness and safety of the operation. This technology can insert a balloon into the stricture section of the ureteroscope under direct vision and dilate the narrow section of the ureter, and the whole process only takes about 10 min. It avoids the blindness and uncertainty of endoscopic body expansion and can reduce the occurrence of complications such as ureteral perforation, tear, and disconnection. The operation process is precise and reliable, and it also avoids the radiation of X-ray to both doctors and patients.
