Torrecilla, CarlosFernández Concha, JaimeCansino, José R.Mainez, Juan A.Amón, José H.Costas, SimbadAngerri, OriolEmiliani, EstebanArrabal Martín, Miguel A.Arrabal Polo, Miguel A.García, AnaReina, Manuel C.Sánchez, Juan F.Budía, AlbertoPérez Fentes, DanielGrases, FélixCosta Bauzá, AntoniaCuñé, Jordi2021-02-032021-02-032020-06-05https://hdl.handle.net/2445/173615Background: Encrustation of ureteral double J stents is a common complication that may affect its removal. The aim of the proposed study is to evaluate the efficacy and safety of a new oral composition to prevent double J stent encrustation in indwelling times up to 8 weeks. Methods: A double-blinded, multicenter, placebo-controlled trial was conducted with 105 patients with indwelling double J stents enrolled across 9 public hospitals in Spain. The patients were randomly assigned (1:1) into intervention (53 patients) or placebo (52 patients) groups for 3 to 8 weeks and both groups self-monitored daily their morning urine pH levels. The primary outcome of analysis was the degree of stent ends encrustation, defined by a 4-point score (0 - none; 3 - global encrustation) using macroscopic and electron microscopy analysis of crystals, after 3 to 8-w indwelling period. Score was exponentially transformed according to calcium levels. Secondary endpoints included urine pH decrease, stent removal, and incidence of adverse events. Results: The intervention group benefits from a lower global encrustation rate of stent ends than placebo group (1% vs 8.2%; p < 0.018). Mean encrustation score was 85.12 (274.5) in the placebo group and 18.91 (102.27) in the intervention group (p < 0.025). Considering the secondary end points, treated patients reported greater urine pH decreases (p = 0.002). No differences in the incidence of adverse events were identified between the groups. Conclusions: Our data suggest that the use of this new oral composition is beneficial in the context of ureteral double J indwelling by decreasing mean, as well as global encrustation.12 p.application/pdfengcc by (c) Torrecilla et al., 2020http://creativecommons.org/licenses/by/3.0/es/UrèterAnàlisi d'orinaUretersUrine analysisinfo:eu-repo/semantics/article2021-01-25info:eu-repo/semantics/openAccess32503502