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

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-blinde...

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Autores: Torrecilla, Carlos, Fernández Concha, Jaime, Cansino, José R., Mainez, Juan A., Amón, José H., Costas, Simbad, Angerri, Oriol, Emiliani, Esteban, Arrabal Martín, Miguel A., Arrabal Polo, Miguel A., García, Ana, Reina, Manuel C., Sánchez, Juan F., Budía, Alberto, Pérez Fentes, Daniel, Grases, Félix, Costa Bauzá, Antonia, Cuñé, Jordi
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2020
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/173615
Acceso en línea:https://hdl.handle.net/2445/173615
Access Level:acceso abierto
Palabra clave:Urèter
Anàlisi d'orina
Ureters
Urine analysis
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spelling 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 trialTorrecilla, 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, JordiUrèterAnàlisi d'orinaUretersUrine analysisBackground: 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.BioMed Central2020info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/173615Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.1186/s12894-020-00633-2BMC Urology, 2020, vol. 20https://doi.org/10.1186/s12894-020-00633-2cc by (c) Torrecilla et al., 2020http://creativecommons.org/licenses/by/3.0/es/info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/1736152026-05-27T06:46:51Z
dc.title.none.fl_str_mv 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
title 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
spellingShingle 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, Carlos
Urèter
Anàlisi d'orina
Ureters
Urine analysis
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
dc.creator.none.fl_str_mv Torrecilla, Carlos
Fernández Concha, Jaime
Cansino, José R.
Mainez, Juan A.
Amón, José H.
Costas, Simbad
Angerri, Oriol
Emiliani, Esteban
Arrabal Martín, Miguel A.
Arrabal Polo, Miguel A.
García, Ana
Reina, Manuel C.
Sánchez, Juan F.
Budía, Alberto
Pérez Fentes, Daniel
Grases, Félix
Costa Bauzá, Antonia
Cuñé, Jordi
author Torrecilla, Carlos
author_facet Torrecilla, Carlos
Fernández Concha, Jaime
Cansino, José R.
Mainez, Juan A.
Amón, José H.
Costas, Simbad
Angerri, Oriol
Emiliani, Esteban
Arrabal Martín, Miguel A.
Arrabal Polo, Miguel A.
García, Ana
Reina, Manuel C.
Sánchez, Juan F.
Budía, Alberto
Pérez Fentes, Daniel
Grases, Félix
Costa Bauzá, Antonia
Cuñé, Jordi
author_role author
author2 Fernández Concha, Jaime
Cansino, José R.
Mainez, Juan A.
Amón, José H.
Costas, Simbad
Angerri, Oriol
Emiliani, Esteban
Arrabal Martín, Miguel A.
Arrabal Polo, Miguel A.
García, Ana
Reina, Manuel C.
Sánchez, Juan F.
Budía, Alberto
Pérez Fentes, Daniel
Grases, Félix
Costa Bauzá, Antonia
Cuñé, Jordi
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Urèter
Anàlisi d'orina
Ureters
Urine analysis
topic Urèter
Anàlisi d'orina
Ureters
Urine analysis
description 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.
publishDate 2020
dc.date.none.fl_str_mv 2020
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/173615
url https://hdl.handle.net/2445/173615
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1186/s12894-020-00633-2
BMC Urology, 2020, vol. 20
https://doi.org/10.1186/s12894-020-00633-2
dc.rights.none.fl_str_mv cc by (c) Torrecilla et al., 2020
http://creativecommons.org/licenses/by/3.0/es/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc by (c) Torrecilla et al., 2020
http://creativecommons.org/licenses/by/3.0/es/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv BioMed Central
publisher.none.fl_str_mv BioMed Central
dc.source.none.fl_str_mv Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,300719

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