Clinical Efficacy, Safety, and Costs of Percutaneous Occlusive Balloon Catheter-Assisted Ureteroscopic Lithotripsy for Large Impacted Proximal Ureteral Calculi: A Prospective, Randomized Study

Purpose: To evaluate the clinical efficacy, safety, and costs of percutaneous occlusive balloon catheter-assisted ureteroscopic lithotripsy (POBC-URSL) for large impacted proximal ureteral calculi. Patients and Methods: 156 patients with impacted proximal ureteral stones >= 1.5 cm in size were randomized to ureteroscopic lithotripsy (URSL), POBC-URSL, and percutaneous nephrolithotomy (PNL) group between May 2010 and May 2013. For URSL, the calculi were disintegrated with the assistance of anti-retropulsion devices. POBC-URSL was performed with the assistance of an 8F percutaneous occlusive balloon catheter. PNL was finished with the combination of an ultrasonic and a pneumatic lithotripter. A flexible ureteroscope and a 200 mu m laser fiber were used to achieve stone-free status to a large extent for each group. Variables studied were mean operative time, auxiliary procedure, postoperative hospital stay, operation-related complications, stone clearance rate, and treatment costs. Results: The mean lithotripsy time for POBC-URSL was shorter than URSL, but longer than PNL (42.6 +/- 8.9 minutes vs 66.7 +/- 15.3 minutes vs 28.1 +/- 6.3 minutes, p = 0.014). The auxiliary procedure rate and postoperative fever rate for POBC-URSL were significantly lower than URSL and comparable to PNL (p < 0.01, p = 0.034). POBC-URSL was superior to URSL with regard to the stone clearance rate at 3 days postoperatively, and as good as PNL (98.1% vs 75.0% vs 96.2%, p < 0.01). The postoperative hospital stay and hematuria rate were lower in POBC-URSL group than PNL group and similar to URSL group (p = 0.016, p < 0.01). The treatment costs were lowest in POBC-URSL group ($1205.0 +/-$113.9 vs $1731.7 +/-$208.1 vs $2446.4 +/-$166.4, p = 0.004). Conclusions: For large impacted proximal ureteral calculi, POBC-URSL was associated with a higher stone clearance rate, fewer complications and costs. POBC-URSL combined the advantages of URSL and PNL.