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dc.contributor.authorTorrecilla, C.
dc.contributor.authorFernández-Concha, J.
dc.contributor.authorCansino, J. R.
dc.contributor.authorMainez, J. A.
dc.contributor.authorAmón, J. H.
dc.contributor.authorCostas, S.
dc.contributor.authorAngerri, O.
dc.contributor.authorEmiliani, E.
dc.contributor.authorArrabal Martín, M. A.
dc.contributor.authorArrabal Polo, M. A.
dc.contributor.authorGarcía, A.
dc.contributor.authorReina, M. C.
dc.contributor.authorSánchez García, Juan Francisco
dc.contributor.authorBudía, A.
dc.contributor.authorPérez Fentes, Daniel Alfonso
dc.contributor.authorGrases, F.
dc.contributor.authorCosta-Bauzá, A.
dc.contributor.authorCuñé, J.
dc.date.accessioned2022-04-26T07:45:02Z
dc.date.available2022-04-26T07:45:02Z
dc.date.issued2020
dc.identifier.issn1471-2490
dc.identifier.otherhttps://www.ncbi.nlm.nih.gov/pubmed/32503502es
dc.identifier.urihttp://hdl.handle.net/20.500.11940/16561
dc.description.abstractBACKGROUND: 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.en
dc.rightsAtribución 4.0 Internacional
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subject.meshAdult*
dc.subject.meshMethionine*
dc.subject.meshMiddle Aged*
dc.subject.meshUreter*
dc.subject.meshCalcinosis*
dc.subject.meshCrystallization*
dc.subject.meshProsthesis Failure*
dc.subject.meshUrine*
dc.subject.meshDouble-Blind Method*
dc.subject.meshPostoperative Complications*
dc.subject.meshHydrogen-Ion Concentration*
dc.subject.meshHumans*
dc.subject.meshStents*
dc.subject.meshProspective Studies*
dc.subject.meshPhytic Acid*
dc.titleReduction 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 trialen
dc.typeJournal Articlees
dc.authorsophosTorrecilla, 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, J. F.;Budía, A.;Pérez-Fentes, D.;Grases, F.;Costa-Bauzá, A.;Cuñé, J.
dc.identifier.doi10.1186/s12894-020-00633-2
dc.identifier.pmid32503502
dc.identifier.sophos39418
dc.issue.number1es
dc.journal.titleBmc urologyes
dc.organizationServizo Galego de Saúde::Estrutura de Xestión Integrada (EOXI)::EOXI de Santiago de Compostela - Complexo Hospitalario Universitario de Santiago de Compostela::Uroloxíaes
dc.organizationServizo Galego de Saúde::Estrutura de Xestión Integrada (EOXI)::EOXI de Vigo - Complexo Hospitalario Universitario de Vigo::Uroloxíaes
dc.page.initial65es
dc.rights.accessRightsopenAccess
dc.subject.decscalcinosis*
dc.subject.decsconcentración de iones hidrógeno*
dc.subject.decsácido fítico*
dc.subject.decsorina*
dc.subject.decsfallo de prótesis*
dc.subject.decsestudios prospectivos*
dc.subject.decscristalización*
dc.subject.decsmediana edad*
dc.subject.decsuréter*
dc.subject.decsadulto*
dc.subject.decsmétodo con doble ocultación*
dc.subject.decscomplicaciones postoperatorias*
dc.subject.decsstents*
dc.subject.decshumanos*
dc.subject.decsmetionina*
dc.subject.keywordCHUSes
dc.subject.keywordCHUVIes
dc.typefidesArtículo Originales
dc.typesophosArtículo Originales
dc.volume.number20es


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