%0 Journal Article
%A Torrecilla, Carlos
%A Fernández-Concha, Jaime
%A Cansino, José R
%A Mainez, Juan A
%A Amón, José H
%A Costas, Simbad
%A Angerri, Oriol
%A Emiliani, Esteban
%A Arrabal Martín, Miguel A
%A Arrabal Polo, Miguel A
%A García, Ana
%A Reina, Manuel C
%A Sánchez, Juan F
%A Budía, Alberto
%A Pérez-Fentes, Daniel
%A Grases, Félix
%A Costa-Bauzá, Antonia
%A Cuñé, Jordi
%T Reduction of ureteral stent encrustation by modulating the urine pH and inhibiting the crystal film with a new oral composition: a multicenter, placebo controlled, double blind, randomized clinical trial.
%D 2020
%U http://hdl.handle.net/10668/15690
%X 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. 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. The intervention group benefits from a lower global encrustation rate of stent ends than placebo group (1% vs 8.2%; p  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. This trial was registered at www.clinicaltrials.gov under the name "Combined Use of a Medical Device and a Dietary Complement in Patient Urinary pH Control in Patients With an Implanted Double J Stent" with date 2nd November 2017, code NCT03343275, and URL.
%K Double J stent
%K Encrustation
%K L-methionine
%K Nutraceutical
%K Phytin
%K pH
%~