Methenamine hippurate as prophylaxis for recurrent urinary tract infections in older women-a triple-blind, randomised, placebo-controlled, phase IV trial (ImpresU).

IF 8.5 1区医学 Q1 INFECTIOUS DISEASES

Clinical Microbiology and Infection Pub Date : 2025-07-14 DOI:10.1016/j.cmi.2025.07.006

Silje Rebekka Heltveit-Olsen, Egill Snaebjörnsson Arnljots, Pär-Daniel Sundvall, Ronny Gunnarsson, Anna Kowalczyk, Maciej Godycki-Cwirko, Tamara N Platteel, Wim G Groen, Sara Sofia Lithén, Sofia Sundvall, Christina Åhrén, Nils Grude, Theo J M Verheij, Cees M P M Hertogh, Morten Lindbæk, Sigurd Høye

{"title":"Methenamine hippurate as prophylaxis for recurrent urinary tract infections in older women-a triple-blind, randomised, placebo-controlled, phase IV trial (ImpresU).","authors":"Silje Rebekka Heltveit-Olsen, Egill Snaebjörnsson Arnljots, Pär-Daniel Sundvall, Ronny Gunnarsson, Anna Kowalczyk, Maciej Godycki-Cwirko, Tamara N Platteel, Wim G Groen, Sara Sofia Lithén, Sofia Sundvall, Christina Åhrén, Nils Grude, Theo J M Verheij, Cees M P M Hertogh, Morten Lindbæk, Sigurd Høye","doi":"10.1016/j.cmi.2025.07.006","DOIUrl":null,"url":null,"abstract":"Objectives: This study aims to investigate the preventive effect of the antiseptic methenamine hippurate on recurrent urinary tract infections (rUTIs) in older women.Methods: Triple-blind, randomised, placebo-controlled phase IV trial with a 6-month treatment period and a 6-month follow-up. Women ≥70 years with rUTIs were recruited from general practice in Norway, Sweden, Poland, and The Netherlands. Recruitment started in December 2019, with follow-up completed at the end of June 2023. Participants were randomly assigned to methenamine hippurate 1g × 2 or placebo 1 tablet × 2 for 6 months. The primary outcome was the number of antibiotic treatments for urinary tract infections (UTIs) during the treatment period. Secondary outcomes included the number of antibiotic treatments for UTIs during the follow-up period, UTI symptom severity and episode duration. Differences in complications were measured as safety outcomes.Results: Of 289 recruited women, 281 (97%) were included in the main analysis (140 in the methenamine hippurate group, 141 in the placebo group). During the treatment period, the methenamine hippurate group had a lower incidence of antibiotic treatments for UTIs than the placebo group, with an incidence rate ratio of 0.75 (95% CI: 0.57-1.0, p 0.049). In the follow-up period, the ratio was reversed: the methenamine hippurate group had a higher incidence of antibiotic treatments for UTIs than the placebo group, with an incidence rate ratio of 1.7 (95% CI:1.3-2.3, p<0.001). There were no important differences in UTI symptom severity/duration or complications between the groups.Discussion: Methenamine hippurate reduces the frequency of rUTIs in older women with a point estimate of a 25% reduction, suggesting advantages over low-dose antibiotic prophylaxis because of its low potential for selection for antimicrobial resistance and mild side effects. However, discontinuation after 6-month treatment duration seems to increase the risk of UTI relapses, and physicians should be aware of this risk when initiating or discontinuing treatment.Trial registration number: ClinicalTrials.gov Registry (NCT04077580); EudraCT: 2018-002235.","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":8.5000,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Microbiology and Infection","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.cmi.2025.07.006","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}

引用次数: 0

Abstract

Objectives: This study aims to investigate the preventive effect of the antiseptic methenamine hippurate on recurrent urinary tract infections (rUTIs) in older women.

Methods: Triple-blind, randomised, placebo-controlled phase IV trial with a 6-month treatment period and a 6-month follow-up. Women ≥70 years with rUTIs were recruited from general practice in Norway, Sweden, Poland, and The Netherlands. Recruitment started in December 2019, with follow-up completed at the end of June 2023. Participants were randomly assigned to methenamine hippurate 1g × 2 or placebo 1 tablet × 2 for 6 months. The primary outcome was the number of antibiotic treatments for urinary tract infections (UTIs) during the treatment period. Secondary outcomes included the number of antibiotic treatments for UTIs during the follow-up period, UTI symptom severity and episode duration. Differences in complications were measured as safety outcomes.

Results: Of 289 recruited women, 281 (97%) were included in the main analysis (140 in the methenamine hippurate group, 141 in the placebo group). During the treatment period, the methenamine hippurate group had a lower incidence of antibiotic treatments for UTIs than the placebo group, with an incidence rate ratio of 0.75 (95% CI: 0.57-1.0, p 0.049). In the follow-up period, the ratio was reversed: the methenamine hippurate group had a higher incidence of antibiotic treatments for UTIs than the placebo group, with an incidence rate ratio of 1.7 (95% CI:1.3-2.3, p<0.001). There were no important differences in UTI symptom severity/duration or complications between the groups.

Discussion: Methenamine hippurate reduces the frequency of rUTIs in older women with a point estimate of a 25% reduction, suggesting advantages over low-dose antibiotic prophylaxis because of its low potential for selection for antimicrobial resistance and mild side effects. However, discontinuation after 6-month treatment duration seems to increase the risk of UTI relapses, and physicians should be aware of this risk when initiating or discontinuing treatment.

Trial registration number: ClinicalTrials.gov Registry (NCT04077580); EudraCT: 2018-002235.

查看原文本刊更多论文

马嘌呤甲基苯丙胺预防老年妇女复发性尿路感染——一项三盲、随机、安慰剂对照的IV期试验（ImpresU）

目的：探讨杀菌剂马尿酸甲基苯丙胺对老年妇女复发性尿路感染（rUTIs）的预防作用。方法：三盲、随机、安慰剂对照的IV期试验，6个月的治疗期和6个月的随访。≥70岁的ruti患者从挪威、瑞典、波兰和荷兰的全科医生中招募。招聘于2019年12月开始，后续工作于2023年6月底完成。参与者被随机分配到盐酸甲基苯丙胺1g x 2或安慰剂1片x 2，为期6个月。主要结局是在治疗期间抗生素治疗尿路感染的次数。次要结局包括随访期间尿路感染的抗生素治疗次数、尿路感染症状严重程度和发作持续时间。并发症的差异作为安全结果来衡量。结果：289名招募的女性中，有281名（97%）被纳入主要分析（马尿酸甲基苯丙胺组140名，安慰剂组141名）。在治疗期间，马尿酸甲基苯丙胺组抗生素治疗尿路感染的发生率低于安慰剂组，发生率比为0.75 （95% CI 0.57-1.0, p= 0.049）。在随访期间，这一比例发生了逆转：马嘌呤甲基苯丙胺组抗生素治疗尿路感染的发生率高于安慰剂组，发生率比为1.7 （95% CI为1.3-2.3）。结论：马嘌呤甲基苯丙胺降低了老年妇女尿路感染的频率，点估计降低了25%，由于其低剂量抗生素耐药性选择的可能性和轻微的副作用，表明其优于低剂量抗生素预防。然而，6个月后停止治疗似乎会增加尿路感染复发的风险，医生在开始或停止治疗时应意识到这一风险。试验注册：ClinicalTrials.gov注册中心（NCT04077580）；EudraCT: 2018 - 002235。

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

Clinical Microbiology and Infection 医学-传染病学

CiteScore

25.30

自引率

2.10%

发文量

441

审稿时长

2-4 weeks

期刊介绍： Clinical Microbiology and Infection (CMI) is a monthly journal published by the European Society of Clinical Microbiology and Infectious Diseases. It focuses on peer-reviewed papers covering basic and applied research in microbiology, infectious diseases, virology, parasitology, immunology, and epidemiology as they relate to therapy and diagnostics.