Abstract
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 < 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.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 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.
Highlights
Encrustation of ureteral double J stents is a common complication that may affect its removal
Recent studies have demonstrated that the presence of bacteria is not compulsory and conditioning film, together with urine pH, might play a bigger role in Ca and Mg phosphate precipitates forming hydroxyapatite and brushite crystals, which result in stent encrustation [12]
Inclusion criteria comprised patients aged 18 and older, capable of daily self-monitor their urine pH, who were willing to participate and had recently implanted a double J stent or programmed for it, with an expected indwelling time below 8 weeks, maximum period of time allowed for stent indwelling according to the Ethics Committee
Summary
Encrustation of ureteral double J stents is a common complication that may affect its removal. Recent studies have demonstrated that the presence of bacteria is not compulsory and conditioning film, together with urine pH, might play a bigger role in Ca and Mg phosphate precipitates forming hydroxyapatite and brushite crystals, which result in stent encrustation [12]. Oher factors, such as urine pH and supersaturation, play an important role and several studies have shown that higher urine pH values are found in blocker patients (those in which stent obstruction is observed) compared to non-blocker ones [10, 13, 14]. Stent encrustation could be minimized if urine composition is altered by reducing the urine alkalinisation and increasing the urine excretion of crystallization inhibitors
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