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Alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, non-inferiority trial

Lookup NU author(s): Professor Christopher HardingORCiD, Helen MossopORCiD, Tara HomerORCiD, Dr Thomas Chadwick, Will King, Dr Sonya Carnell, Jan Lecouturier, Dr Alaa AbouhajarORCiD, Professor Luke ValeORCiD, Gillian WatsonORCiD, Rebecca Forbes, Stephanie CurrerORCiD, Rob Pickard, Ased Ali



This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ. OBJECTIVE: To test and compare the efficacy of methenamine hippurate for prevention of recurrent urinary tract infections with the current standard prophylaxis of daily low dose antibiotics. DESIGN: Multicentre, open label, randomised, non-inferiority trial. SETTING: Eight centres in the UK, recruiting from June 2016 to June 2018. PARTICIPANTS: Women aged ≥18 years with recurrent urinary tract infections, requiring prophylactic treatment. INTERVENTIONS: Random assignment (1:1, using permuted blocks of variable length via a web based system) to receive antibiotic prophylaxis or methenamine hippurate for 12 months. Treatment allocation was not masked and crossover between arms was allowed. MAIN OUTCOME MEASURE: Absolute difference in incidence of symptomatic, antibiotic treated, urinary tract infections during treatment. A patient and public involvement group predefined the non-inferiority margin as one episode of urinary tract infection per person year. Analyses performed in a modified intention-to-treat population comprised all participants observed for at least six months. RESULTS: Participants were randomly assigned to antibiotic prophylaxis (n=120) or methenamine hippurate (n=120). The modified intention-to-treat analysis comprised 205 (85%) participants (antibiotics, n=102 (85%); methenamine hippurate, n=103 (86%)). Incidence of antibiotic treated urinary tract infections during the 12 month treatment period was 0.89 episodes per person year (95% confidence interval 0.65 to 1.12) in the antibiotics group and 1.38 (1.05 to 1.72) in the methenamine hippurate group, with an absolute difference of 0.49 (90% confidence interval 0.15 to 0.84) confirming non-inferiority. Adverse reactions were reported by 34/142 (24%) in the antibiotic group and 35/127 (28%) in the methenamine group and most reactions were mild. CONCLUSION: Non-antibiotic prophylactic treatment with methenamine hippurate might be appropriate for women with a history of recurrent episodes of urinary tract infections, informed by patient preferences and antibiotic stewardship initiatives, given the demonstration of non-inferiority to daily antibiotic prophylaxis seen in this trial. TRIAL REGISTRATION: ISRCTN70219762.

Publication metadata

Author(s): Harding C, Mossop H, Homer T, Chadwick T, King W, Carnell S, Lecouturier J, Abouhajar A, Vale L, Watson G, Forbes R, Currer S, Pickard R, Eardley I, Pearce I, Thiruchelvam N, Guerrero K, Walton K, Hussain Z, Lazarowicz H, Ali A

Publication type: Article

Publication status: Published

Journal: BMJ

Year: 2022

Volume: 376

Online publication date: 09/03/2022

Acceptance date: 24/12/2021

Date deposited: 24/03/2022

ISSN (print): 0959-8138

Publisher: BMJ Group


DOI: 10.1136/bmj-2021-0068229

PubMed id: 35264408


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