Flexible ureteroscopy using a digital single-use flexible ureteroscope known as PUSEN achieves stone-free rates on par with reusable flexible ureteroscopes, with a total surgery time averaging 45 minutes.
These were the findings from an initial experience with the digital single-use flexible ureteroscope in 11 patients at Clínica Santa María in Santiago, Chile.
“The clinical results achieved in the present study suggest that this device could be considered a valid method to treat endoscopically renal and proximal ureteral stones, reducing maintenance costs,” said lead investigator José A. Salvadó, MD, at the AUA annual meeting in Boston.
“The cost of a disposable scope is about $800 U.S. each,” he said. “On the other hand, the cost of a reusable endoscope can reach, in Chile, up to $40,000—with an average duration of 25 procedures, that is to say twice as much as a disposable one, without considering the cost associated with sterilization.”
Problems with the use of flexible ureteroscopes have been documented.
“You have progressive deterioration of the scope performance and costly repairs,” said Dr. Salvadó, director of the Center for Comprehensive Management of Urinary Stone Disease at Clínica Santa María. “We have some problems with sterilization, risk of failure in decontamination, and we have also the cost of maintenance.”
Reusable scopes linked with damage, repairs
Carey et al reported damage during 8.1% of uses and the need for a new ureteroscope to be repaired after about 40 uses (J Urol 2006; 176:607-10). After a comprehensive repair, these new ureteroscopes averaged only 11 more uses before again needing repair.
Semins et al (J Endourol 2009; 23:903-5) found that the cleaning and sterilization process can damage ureteroscopes. In their analysis, the average number of flexible ureteroscope uses before repair was 28, and the cost per use was $128 when amortizing repair costs.
The clinical results of ureteroscopy using the new PUSEN digital single-use flexible ureteroscope were evaluated by Dr. Salvadó and co-investigators. The device has a 270-degree deflection on both sides, a 9F external diameter, and a working channel of 3.6F. The authors examined a prospective registry of consecutive cases performed by a single urologist using the new single-use ureteroscope between August and October 2016.
A total of 11 procedures with the single-use flexible ureteroscope was performed on eight male and three female patients. The average age of the overall group was 39 years. All the patients were treated using a 12F access sheath and holmium laser lithotripsy with a 260-µm fiber. The average stone size was 6 mm, with a range of 4 to 10 mm. Stone location was as follows: three in the proximal ureter, six in the renal pelvis, and two in the lower calix.
The average total surgery time was 45 minutes, with a range of 25 to 85 minutes. The number of stones treated per patient varied from one to four. The mean fluoroscopy time was 50 seconds. Non-contrast computed tomography scan at 3 weeks showed the stone-free rates to be 100% in eight patients and 80% in three patients. One patient presented with a ureteral wall injury, with mucosal erosion at time of ureteral access sheath placement.
The device behaved properly, with no loss in image quality or deflection capacity during the procedure, said Dr. Salvadó.