Purpose: To prospectively evaluate the new Flexor©Parallel™ Rapid Release™ (Cook(®), Bloomington, IN, USA) access sheath (UAS) which allows the use of a single wire to serve as both safety and working guide.
Materials and methods: Between June and September 2014, adult patients from five European centers who underwent flexible ureteroscopy (fURS) for therapeutic and diagnostic purposes were included. The 12/14Fr Flexor©Parallel™ UAS was evaluated. Data were collected and examined by both univariate and multivariate analyses. The UAS material and usage characteristics were rated per case by the surgeons on a scale from very bad to very good.
Results: In total, 134 UASs were used in 67 male and 67 female patients. Fifty percent of ureters (67 patients) were pre-stented. Ninety percent of the procedures were therapeutic. The overall successful insertion rate was 94 %. Pre-stenting status was the only independent factor for a successful access sheath insertion: 98.5 % of the pre-stented patients had a successful UAS placement vs. 82 % of non-pre-stented (p = 0.001, C.I. 95 %: 1.2). Evaluation of the material and radiopacity was considered very good in over 90 % of cases. Release of the guidewire, hydrophilic coating, gliding of the endoscope and repeatability were considered very good in over 80 %. There were two (1.4 %) UAS malfunctions and one submucosal lesion reported.
Conclusions: The use of the Flexor©Parallel™ Rapid Release™ (Cook(®), Bloomington, IN, USA) with usage of a single guidewire in a prospective multicentric scenario was clinically applicable in the majority of cases. Pre-stenting increased the chance of a successful insertion from 82 to 98.5 %.
Keywords: Endourology; Flexible ureteroscopy; Single-use guidewire; Ureteral access sheath; Urolithiasis.