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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.

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

SUBMITTER: Torrecilla C

PROVIDER: S-EPMC7275439 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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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 C Fernández-Concha Jaime J Cansino José R JR Mainez Juan A JA Amón José H JH Costas Simbad S Angerri Oriol O Emiliani Esteban E Arrabal Martín Miguel A MA Arrabal Polo Miguel A MA García Ana A Reina Manuel C MC Sánchez Juan F JF Budía Alberto A Pérez-Fentes Daniel D Grases Félix F Costa-Bauzá Antonia A Cuñé Jordi J

BMC urology 20200605 1

<h4>Background</h4>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.<h4>Methods</h4>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 ( ...[more]

PMID: 32503502

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Project description:Ureteral stent encrustation significantly limits indwelling time and can lead to downstream urological problems. However, no ideal polymeric biomaterials have been shown to completely resist encrustation in long-term urine exposure. Recently, 2-hydroxyethyl methacrylate (HEMA)-coated Pellethane was reported as a promising biomaterial resistant to encrustation. This study compared HEMA-coated Pellethane to commercially available stents under two different artificial urine environments. To evaluate the degree and composition of encrustation on HEMA-coated Pellethane, Boston Scientific Tria, Bard InLay Optima, Cook Universa Hydrogel, and Cook Black Silicone stents were used at various dwelling times in two different artificial urine environments. In a batch-flow model, samples of stents were suspended in an artificial urine solution (AUS) at 37 °C. Every 24 h for 11 weeks, 50% of the AUS would be replaced with fresh components using a programmable peristaltic pump system. The stent materials were removed at suitable time intervals and air-dried for 24 h under sterile conditions before follow-up analysis. SEM was used to assess the degree of encrustation, and inductively coupled plasma mass spectrometry (ICP-MS) was employed to quantify the encrusted compositions, specifically for calcium, magnesium, and phosphorus. We measured the weight gain over time due to encrusted deposits on the stents and quantified the amount of Ca, Mg, and P deposited on each encrusted stent. After the 11 week trial, HEMA-coated Pellethane showed the most average mass change. SEM showed that HEMA-coated Pellethane was fully encrusted in just 2 weeks in the AUS environments, and ICP-MS showed that Ca is the most abundant deposit. Among all the tested stents, Black Silicone performed the best. The two AUSs were formulated to encrust more rapidly than physiological conditions. HEMA-coated Pellethane is not an ideal stent material, while silicone is a promising material for advancing ureteral stents.

Project description:IntroductionWe aimed to assess the effects of postoperative ureteral stent placement after uncomplicated ureteroscopy.MethodsWe performed a comprehensive search with no restrictions on publication language or status up to February 1, 2019. We only included randomized trials. Two review authors independently examined full-text reports, identified relevant studies, assessed the eligibility of studies for inclusion, extracted data, and assessed risk of bias. We performed statistical analyses using a random-effects model and assessed the certainty of the evidence according to GRADE.ResultsWe included 23 studies with 2656 randomized patients. Primary outcomes: It is uncertain whether stenting reduces the number of unplanned return visits (very low certainty of evidence [CoE]). Pain on the day of surgery is probably similar (mean difference [MD] 0.32; 95% confidence interval (CI) -0.13-0.78; moderate CoE). Pain on postoperative days 1-3 may show little to no difference (standardized mean difference [SMD] 0.25; 95% CI -0.32-0.82; low CoE). It is uncertain whether stented patients experience more pain on postoperative days 4-30 (very low CoE). Stenting may result in little to no difference in the need for secondary interventions (risk ratio [RR] 1.15; 95% CI 0.39-3.33; low CoE).Secondary outcomesWe are uncertain whether stenting reduces the need for narcotics and reduces ureteral stricture rates up to 90 days (very low CoE). Rates of hospital admission may be slightly reduced (RR 0.70; 95% CI 0.32-1.55; low CoE). This review was limited to patients in whom ureteroscopy was deemed 'uncomplicated.' In addition, time intervals for the grouping for the reported degree of pain were established post-hoc. The CoE for most outcomes was rated as low or very low for methodological reasons.ConclusionsFindings of this review illustrate the tradeoffs of risks and benefits faced by urologists and their patients when it comes to decision-making about stent placement after uncomplicated ureteroscopy for stone disease.

Dataset Information

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.

Publications

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.

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