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

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Abstract

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.

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Conflict of interest

The study was financially supported by the Coloplast company. Olivier Traxer and Cesare Scoffone are consultants for Coloplast. Other authors have nothing to disclose. The authors analyzed the results and wrote the manuscript without any external influence from Coloplast.

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Correspondence to Olivier Traxer.

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Doizi, S., Knoll, T., Scoffone, C.M. et al. First clinical evaluation of a new innovative ureteral access sheath (Re-Trace™): a European study. World J Urol 32, 143–147 (2014). https://doi.org/10.1007/s00345-013-1094-3

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  • DOI: https://doi.org/10.1007/s00345-013-1094-3

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