Presentation Authors: Oliver Wiseman*, Cambridge, United Kingdom, Julien Letendre, Montreal, Canada, Jonathan Cloutier, Quebec, Canada, Michel Daudon, Paris, France, Francois Kleinclauss, Besancon, France, Steeve Doizi, Olivier Traxer, Paris, France
Introduction: Silicone was one of the first materials to be used for DJ ureteral stents. Due to its softness, it is purported to be associated with less patient discomfort. However, there are no clinical trials showing this. In this large multicenter prospective study, we compared the hydrocoated silicone stent (Coloplast ImajinÂ® hydro) to PercuflexTM Plus stent (Boston Scientific) in terms of patient comfort after flexible ureteroscopy (FURS) for stone disease over a 5-week prospective follow-up.
Methods: Between November 2013 and December 2017, 141 patients treated for unilateral renal stones from 5 to 25 mm by F-URS were randomized, following ethical committee approval in the respective centres, under a prospective, comparative, single blind, parallel groups protocol across 4 centres in France, UK and Canada. The primary endpoint was USSQ Body Pain Index recorded before DJ removal at D20. Secondary endpoints were USSQ scores at intermediate dates (D2, D7) and 2 weeks after stent withdrawal (D35), pain score, quality of life, adverse events, and encrustation. Exclusion criteria included pregnancy, active infection, chronic pain, urogenital tumor, presence of an implanted double J stent, treatment for BPH, prostatitis, or neuro/cognitive disease. Treatment A (silicone ImajinÂ® hydro) and Treatment B (PercuflexTM Plus) were assigned using a blocked centralized randomization list.
Results: Table 1 presents the intent-to-treat analysis results. No difference was noticed between the 2 groups regarding demographic characteristics, clinical history, size and treatment of stone or initial pain. D20 USSQ Body Pain Index were available for 104 patients, showing a statistically significant difference in favour of the Imajin hydroÂ® silicone stents compared to PercuflexTM Plus, as did USSQ for urinary symptoms at each time point during indwell duration.
Conclusions: The primary results of this large sample prospective comparative randomized study comparing the Coloplast ImajinÂ® hydro silicone stents to the Boston Scientific PercuflexTM Plus stent shows that silicone stents are associated with significantly less patient discomfort. We would recommend their use in patients who require stenting for stone disease.
Source of Funding: This study was funded by Coloplast.