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 Åhren, 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 Åhren, 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":"Objective: 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 six-month treatment period and a six-month follow-up. Women ≥ 70 years with rUTIs were recruited from general practice in Norway, Sweden, Poland, and The Netherlands. Recruitment started December 2019, with follow-up completed at the end of June 2023. Participants were randomised to methenamine hippurate 1g x 2 or placebo 1 tablet x 2 for six months. The primary outcome was number of antibiotic treatments for UTIs during the treatment period. Secondary outcomes included 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.Conclusion: 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 due to its low potential for selection for antimicrobial resistance and mild side effects. However, discontinuation after six-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: 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

Objective: 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 six-month treatment period and a six-month follow-up. Women ≥ 70 years with rUTIs were recruited from general practice in Norway, Sweden, Poland, and The Netherlands. Recruitment started December 2019, with follow-up completed at the end of June 2023. Participants were randomised to methenamine hippurate 1g x 2 or placebo 1 tablet x 2 for six months. The primary outcome was number of antibiotic treatments for UTIs during the treatment period. Secondary outcomes included 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.

Conclusion: 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 due to its low potential for selection for antimicrobial resistance and mild side effects. However, discontinuation after six-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: 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.