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 (0none; 3global 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.
Penile prosthesis is the treatment of choice for erectile dysfunction (ED) refractory to medical treatment; vasculogenic ED and ED postradical prostatectomy (PRP) are the main aetiologies. Few studies have compared surgical outcomes of penile prosthesis placement for vasculogenic versus PRP severe erectile dysfunction. This study includes 117 cases corresponding to virgin implants for ED of either vasculogenic aetiology or PRP (58 for PRP and 59 for vasculogenic cases). We analysed data corresponding to: age, comorbidity, type of prosthesis, presence of fibrosis that hinders dilation, need for modelling, size of implanted cylinders and complications (intra and postoperative). In the results the rate of hypertension, diabetes, dyslipidaemia and ischemic heart disease was higher in vasculogenic ED. All of the prostheses were hydraulic; 24.1% of two components and 75.9% of three in the PRP group; 39% components of two and 61% of three in the vasculogenic group. With regard to the presence of cavernous fibrosis and need for modelling, no significant differences were found. However, significant differences were observed in the size of the implanted cylinders; PRP of 18.30 ± 2.11 cm versus 19.21 ± 1.71 cm in vasculogenic ED (p = 0.01643). There were no significant differences between the groups in infection rates, mechanical failure or extrusion. In conclusion the implantation of penile prosthesis in ED after PRP is associated with a shorter cylinder length compared with vasculogenic origin. Although there was a certain non-significant tendency to the need for modelling manoeuvres in PRP, there were no significant differences in postoperative outcomes including infection or mechanical failure.
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 or placebo 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 intervention group and 18.91 (102.27) in the placebo 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 2 nd November 2017, code NCT03343275, and URL: https://clinicaltrials.gov/ct2/show/record/NCT03343275?term=NCT03343275&draw=2&rank=1 Keywords: double J stent; encrustation; nutraceutical; L-methionine; phytin; pH.
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