First clinical evaluation of a new innovative ureteral access sheath (Re-Trace™): a European study.

Purpose: The use of a ureteral access sheath (UAS) during flexible retrograde intrarenal surgery (RIRS) has become increasingly popular. Our aim was to evaluate the accessibility of a new UAS device, allowing the transformation of the working guidewire into a safety guidewire.
Methods: A prospective, multicenter study was conducted between January and February 2010 in six European tertiary reference centers. Patients needing flexible RIRS were eligible to participate in the study. In all cases, insertion of the Re-Trace™ (12/14Fr, Coloplast, Denmark) was attempted at the beginning of the procedure. Insertion success was defined as placement of the UAS in the lumbar ureter with successful disengagement of the working guidewire, which turned into a safety guidewire. Influence of gender and pre-stenting status was analyzed by univariate analysis.
Results: 137 UASs were used in 75 male and 62 female patients. 25.5% of ureters were pre-stented: men were 2.17 more often pre-stented than women. The overall Re-Trace™ insertion rate was 82.5%. Success rate was not significantly different between men and women (77.3 vs. 88.7%, respectively, p = 0.11). Pre-stenting status did not significantly influence the success rate (p = 0.31). When analyzing the combined influence of pre-stenting status and gender, the worst success rates seemed to be obtained in men without pre-stenting, but no significant differences were found between groups.
Conclusions: Re-Trace™ UAS showed good overall insertion rates. This evaluation validated the new concept of guidewire disengagement: A single wire automatically switches from working to safety role.