Evaluation of citrate-based nutraceutical combinations and their impact on chemolysis in the management of urinary diversion device: a randomised double-blind placebo-controlled study on improved quality of life and clinical outcomes.

IF 2.9 2区 医学 Q2 UROLOGY & NEPHROLOGY
Anna Ricapito, Nicola Schiavone, Marco Finati, Nicola d'Altilia, Fabrizio Palumbo, Angelo Cormio, Rossana G Iannitti, Giada Ceccarelli, Ugo G Falagario, Carlo Bettocchi, Luigi Cormio, Giuseppe Carrieri, Gian Maria Busetto
{"title":"Evaluation of citrate-based nutraceutical combinations and their impact on chemolysis in the management of urinary diversion device: a randomised double-blind placebo-controlled study on improved quality of life and clinical outcomes.","authors":"Anna Ricapito, Nicola Schiavone, Marco Finati, Nicola d'Altilia, Fabrizio Palumbo, Angelo Cormio, Rossana G Iannitti, Giada Ceccarelli, Ugo G Falagario, Carlo Bettocchi, Luigi Cormio, Giuseppe Carrieri, Gian Maria Busetto","doi":"10.1007/s00345-025-05788-x","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>We aimed to evaluate in a double-blind randomized placebo-controlled trial (RCT) the effectiveness of two citrate-based products in preventing ureteral stent encrustation in patients with severe urinary system damage requiring long-term stent placement and frequent replacements to prevent complications.</p><p><strong>Methods: </strong>Men and women aged 50-80, with severe urinary system damage were randomized to Product 1, Product 2 or Placebo. Efficacy points included encrustation prevention analyzed by mean normalized Kidney, Ureter and Bladder (KUB) score, ease of stent removal, and rate of emergency room (ER) visits.</p><p><strong>Results: </strong>Of 142 patients randomized (Product 1, n = 37; Product 2, n = 62; Placebo, n = 43) 142 received treatment and 138 reached 9 months of follow-up. At 3 months Product 1 was associated with significant improvements vs. Product 2 by means of mean normalized KUB (mnKUB) score (W = - 5.75, p < 0.001). At 6 months both Product 1 and Product 2 were associated with significant improvements vs. Placebo (W = - 7.05, p < 0.001) and (W=-6.55, p < 0.001) respectively. Similar results were obtained at 9 months (Product 1 vs. Placebo, W = - 4.84, p = 0.002; Product 2 vs. Placebo, W = - 4.15, p = 0.009). These outputs agree with that obtained for ease of stent removal, while no differences were found where evaluating the rate of ER visits in the three groups.</p><p><strong>Conclusion: </strong>This study emphasises the efficacy of a combination of potassium and magnesium citrates, Phillantus niruri, Ceterach officinarum and hyaluronic acid (Product 1) in managing long-term ureteral stent dependency, enhancing clinical outcomes and improving patient quality of life (QOL).</p>","PeriodicalId":23954,"journal":{"name":"World Journal of Urology","volume":"43 1","pages":"458"},"PeriodicalIF":2.9000,"publicationDate":"2025-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"World Journal of Urology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00345-025-05788-x","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

Purpose: We aimed to evaluate in a double-blind randomized placebo-controlled trial (RCT) the effectiveness of two citrate-based products in preventing ureteral stent encrustation in patients with severe urinary system damage requiring long-term stent placement and frequent replacements to prevent complications.

Methods: Men and women aged 50-80, with severe urinary system damage were randomized to Product 1, Product 2 or Placebo. Efficacy points included encrustation prevention analyzed by mean normalized Kidney, Ureter and Bladder (KUB) score, ease of stent removal, and rate of emergency room (ER) visits.

Results: Of 142 patients randomized (Product 1, n = 37; Product 2, n = 62; Placebo, n = 43) 142 received treatment and 138 reached 9 months of follow-up. At 3 months Product 1 was associated with significant improvements vs. Product 2 by means of mean normalized KUB (mnKUB) score (W = - 5.75, p < 0.001). At 6 months both Product 1 and Product 2 were associated with significant improvements vs. Placebo (W = - 7.05, p < 0.001) and (W=-6.55, p < 0.001) respectively. Similar results were obtained at 9 months (Product 1 vs. Placebo, W = - 4.84, p = 0.002; Product 2 vs. Placebo, W = - 4.15, p = 0.009). These outputs agree with that obtained for ease of stent removal, while no differences were found where evaluating the rate of ER visits in the three groups.

Conclusion: This study emphasises the efficacy of a combination of potassium and magnesium citrates, Phillantus niruri, Ceterach officinarum and hyaluronic acid (Product 1) in managing long-term ureteral stent dependency, enhancing clinical outcomes and improving patient quality of life (QOL).

评价以柠檬酸盐为基础的营养品组合及其对尿分流装置管理中化学溶解的影响:一项改善生活质量和临床结果的随机双盲安慰剂对照研究。
目的:我们旨在通过一项双盲随机安慰剂对照试验(RCT)评估两种基于柠檬酸盐的产品在严重泌尿系统损伤患者中预防输尿管支架结痂的有效性,这些患者需要长期放置支架并经常更换以预防并发症。方法:年龄50-80岁,泌尿系统严重损伤的男性和女性随机分为产品1、产品2和安慰剂组。疗效点包括预防结痂,通过肾脏、输尿管和膀胱(KUB)平均归一化评分、支架取出难易程度和急诊室(ER)就诊率进行分析。结果:142例随机患者(产品1,n = 37;积2,n = 62;安慰剂组(n = 43) 142例接受治疗,138例随访9个月。在3个月时,通过标准化KUB (mnKUB)平均评分,产品1与产品2相比有显著改善(W = - 5.75, p)。结论:本研究强调了枸橼酸钾和镁、海兰、海兰和透明质酸(产品1)联合治疗输尿管支架长期依赖的疗效,增强了临床结果,改善了患者的生活质量(QOL)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
World Journal of Urology
World Journal of Urology 医学-泌尿学与肾脏学
CiteScore
6.80
自引率
8.80%
发文量
317
审稿时长
4-8 weeks
期刊介绍: The WORLD JOURNAL OF UROLOGY conveys regularly the essential results of urological research and their practical and clinical relevance to a broad audience of urologists in research and clinical practice. In order to guarantee a balanced program, articles are published to reflect the developments in all fields of urology on an internationally advanced level. Each issue treats a main topic in review articles of invited international experts. Free papers are unrelated articles to the main topic.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信