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
Torrecilla, C.; Fernández-Concha, J.; Cansino, J. R.; Mainez, J. A.; Amón, J. H.; Costas, S.; Angerri, O.; Emiliani, E.; Arrabal Martín, M. A.; Arrabal Polo, M. A.; García, A.; Reina, M. C.; Sánchez García, Juan Francisco; Budía, A.; Pérez Fentes, Daniel Alfonso; Grases, F.; Costa-Bauzá, A.; Cuñé, J.
Files view or download
Files view or download
Type of content
DeCScalcinosis | concentración de iones hidrógeno | ácido fítico | orina | fallo de prótesis | estudios prospectivos | cristalización | mediana edad | uréter | adulto | método con doble ocultación | complicaciones postoperatorias | stents | humanos | metionina
MeSHAdult | Methionine | Middle Aged | Ureter | Calcinosis | Crystallization | Prosthesis Failure | Urine | Double-Blind Method | Postoperative Complications | Hydrogen-Ion Concentration | Humans | Stents | Prospective Studies | Phytic Acid
BACKGROUND: 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. TRIAL REGISTRATION: 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.