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.

Autor: Torrecilla C; Bellvitge University Hospital, Barcelona, Spain., Fernández-Concha J; Bellvitge University Hospital, Barcelona, Spain., Cansino JR; La Paz University Hospital, Madrid, Spain., Mainez JA; La Paz University Hospital, Madrid, Spain., Amón JH; Rio Hortega University Hospital, Valladolid, Spain., Costas S; Mateu Orfila Hospital, Maó, Spain., Angerri O; Puigvert Foundation, Barcelona, Spain., Emiliani E; Puigvert Foundation, Barcelona, Spain., Arrabal Martín MA; San Cecilio University Hospital, Granada, Spain., Arrabal Polo MA; San Cecilio University Hospital, Granada, Spain., García A; Virgen de Valme University Hospital, Sevilla, Spain., Reina MC; Virgen de Valme University Hospital, Sevilla, Spain., Sánchez JF; Álvaro Cunqueiro Hospital, Vigo, Spain., Budía A; University and Polytechnic La Fe Hospital, Valencia, Spain., Pérez-Fentes D; University Hospital Complex of Santiago de Compostela, Santiago de Compostela, Spain., Grases F; Laboratory of Renal Lithiasis Research, University Institute of Health Sciences Research (IUNICS- IDISBA), University of Balearic Islands (UIB), Palma de Mallorca, Spain. fgrases@uib.es., Costa-Bauzá A; Laboratory of Renal Lithiasis Research, University Institute of Health Sciences Research (IUNICS- IDISBA), University of Balearic Islands (UIB), Palma de Mallorca, Spain., Cuñé J; Devicare S.L., Cerdanyola del Vallès, Spain.
Jazyk: angličtina
Zdroj: BMC urology [BMC Urol] 2020 Jun 05; Vol. 20 (1), pp. 65. Date of Electronic Publication: 2020 Jun 05.
DOI: 10.1186/s12894-020-00633-2
Abstrakt: 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.
Databáze: MEDLINE
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