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: | Miguel Arrabal Martín, Juan F. Sánchez, Miguel Ángel Arrabal Polo, Juan Antonio Mainez, J.R. Cansino, Esteban Emiliani, Jaime Fernández-Concha, Daniel Pérez-Fentes, Ana M. García, Manuel C. Reina, Simbad Costas, Alberto Budía, Oriol Angerri, José H. Amón, Felix Grases, Carlos Torrecilla, Antonia Costa-Bauzá, Jordi Cuñé |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Ureters
Male medicine.medical_treatment humanos 030232 urology & nephrology Administration Oral Urine Urine analysis lcsh:RC870-923 uréter law.invention 0302 clinical medicine Methionine Postoperative Complications Randomized controlled trial law estudios prospectivos calcinosis Prospective Studies mediana edad pH Calcinosis fallo de prótesis General Medicine Urèter Hydrogen-Ion Concentration Middle Aged adulto Phytin Prosthesis Failure Double J stent stents 030220 oncology & carcinogenesis Stents Female Nutraceutical Crystallization Research Article Adult medicine.medical_specialty Phytic Acid ácido fítico Urology Urinary system Context (language use) Placebo Encrustation orina 03 medical and health sciences Double-Blind Method concentración de iones hidrógeno cristalización medicine Humans método con doble ocultación L-methionine Adverse effect business.industry Stent Anàlisi d'orina lcsh:Diseases of the genitourinary system. Urology Reproductive Medicine complicaciones postoperatorias Ureter metionina Complication business |
| Zdroj: | BMC Urology Dipòsit Digital de la UB Universidad de Barcelona BMC Urology, Vol 20, Iss 1, Pp 1-12 (2020) r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe instname |
| ISSN: | 1471-2490 |
| DOI: | 10.1186/s12894-020-00633-2 |
| Popis: | BackgroundEncrustation 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.MethodsA 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.ResultsThe intervention group benefits from a lower global encrustation rate of stent ends than placebo group (1% vs 8.2%;p p p = 0.002). No differences in the incidence of adverse events were identified between the groups.ConclusionsOur 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 registrationThis trial was registered atwww.clinicaltrials.govunder 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, codeNCT03343275, and URL. |
| Databáze: | OpenAIRE |
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