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

BMC Urology

Jaime Fernández-Concha¹  Carlos Torrecilla¹  Jordi Cuñé²  Juan A. Mainez³  José R. Cansino³  Félix Grases⁴  Antonia Costa-Bauzá⁴  Simbad Costas⁵  Esteban Emiliani⁶  Oriol Angerri⁶  José H. Amón⁷  Miguel A. Arrabal Polo⁸  Miguel A. Arrabal Martín⁸  Daniel Pérez-Fentes⁹  Alberto Budía^1,10  Ana García^1,11  Manuel C. Reina^1,11  Juan F. Sánchez^1,12 

[1]Bellvitge University Hospital

[2]Devicare S.L.

[3]La Paz University Hospital

[4]Laboratory of Renal Lithiasis Research, University Institute of Health Sciences Research (IUNICS- IDISBA), University of Balearic Islands (UIB)

[5]Mateu Orfila Hospital

[6]Puigvert Foundation

[7]Rio Hortega University Hospital

[8]San Cecilio University Hospital

[9]University Hospital Complex of Santiago de Compostela

[10]University and Polytechnic La Fe Hospital

[11]Virgen de Valme University Hospital

[12]Álvaro Cunqueiro Hospital

关键词: Double J stent;    Encrustation;    Nutraceutical;    L-methionine;    Phytin;    pH;   

DOI  :  10.1186/s12894-020-00633-2

来源: DOAJ

【 摘 要 】

Abstract 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.

【 授权许可】

Unknown