Bellvitge University Hospital, Barcelona, Spain.
La Paz University Hospital, Madrid, Spain.
BMC Urol. 2020 Jun 5;20(1):65. doi: 10.1186/s12894-020-00633-2.
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.
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.
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.
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.
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.
输尿管双 J 支架的结石形成是一种常见的并发症，可能会影响其取出。本研究旨在评估一种新的口服组合物在留置时间长达 8 周内预防双 J 支架结石形成的疗效和安全性。
这项双盲、多中心、安慰剂对照试验纳入了西班牙 9 家公立医院的 105 名留置双 J 支架的患者。患者被随机分配（1:1）进入干预组（53 例）或安慰剂组（52 例），留置时间为 3 至 8 周，两组患者均自行监测每日晨尿 pH 值。主要分析结果是支架末端结石形成程度，采用宏观和电子显微镜分析晶体，根据钙水平将评分（0-无；3-完全结石形成）转换为指数形式。次要终点包括尿 pH 值降低、支架取出和不良事件发生率。
与安慰剂组相比，干预组的支架末端总体结石形成率较低（1%比 8.2%；p<0.018）。安慰剂组的平均结石形成评分是 85.12（274.5），干预组是 18.91（102.27）（p<0.025）。考虑到次要终点，治疗组报告的尿 pH 值降低更大（p=0.002）。两组不良事件发生率无差异。
我们的数据表明，在留置输尿管双 J 支架的情况下，使用这种新的口服组合物通过降低平均和总体结石形成率是有益的。
这项试验在 www.clinicaltrials.gov 上以“医疗器械和膳食补充剂联合应用于植入双 J 支架患者尿液 pH 值控制”的名称注册，注册日期为 2017 年 11 月 2 日，注册号为 NCT03343275，网址为。
