Retrograde endoscopic lithotripsy using the innovative nanosecond electropulse method

Abstract

Purpose The purpose of this clinical study is to assess the safety and efficiency of a novel lithotripsy method for endoscopic treatment of urinary stones throughout the urinary tract via semi-rigid and flexible endoscopes. This new method is based on the transfer of nanosecond high voltage electric pulses to the stones through flexible probes of various sizes.

Methods The study involved 879 patients aged 19-88 with renal, ureter and bladder calculi. Gender distribution: 46.3% female and 53.7% male. The prospective single-arm study took place at three centers. The goal of the clinical study was to evaluate the safety and efficacy of a novel lithotripsy method. All treatments were performed retrograde transurethrally. A variety of probes were used for stone fragmentation at different locations. Auxiliary treatments and adverse events were recorded as per protocol. Statistical analysis was conducted using SPSS software.

Results Nanosecond electropulse lithotripsy (NEPL) was found to be technically feasible for all patients with stones located in the kidney, UPJ, ureter and bladder. It requires only a few dozen pulses to disintegrate stones while causing only minor stone migration. The overall stone-free rate in the study was 96%. The average time required for executing the entire procedure was 45±28 min. The overwhelming majority of intraoperative complications occurred due to endoscopic manipulation when using a rigid ureterorenoscope and not due to lithotripsy impact.

Conclusions NEPL is a new, efficient and safe method for urinary stone disintegration that can be used throughout the urinary tract using rigid and flexible endoscopes. Intraoperative complications of the NEPL procedure do not exceed the percentage of adverse effects observed in other lithotripsy methods. The main advantages of relatively low-cost NEPL are fast stone fragmentation requiring only a few dozen pulses to disintegrate stones, tissue safety and availability of highly flexible probes for treating stones in the lower pole through a flexible ureterorenoscope.