Alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, non-inferiority trial. (9th March 2022)

• Record Type: Journal Article
• Authors: Harding, Chris; Mossop, Helen; Homer, Tara; Chadwick, Thomas; King, William; Carnell, Sonya; Lecouturier, Jan; Abouhajar, Alaa; Vale, Luke; Watson, Gillian; Forbes, Rebecca; Currer, Stephanie; Pickard, Robert; Eardley, Ian; Pearce, Ian; Thiruchelvam, Nikesh; Guerrero, Karen; Walton, Katherine; Hussain, Zahid; Lazarowicz, Henry; Ali, Ased
• Is Part Of: BMJ. Volume 376(2022)
• Publication Date: 2022-03-09
• Subjects: Medicine -- Periodicals; Medicine -- Periodicals; Medicine; Periodicals; 610
• DOI: 10.1136/bmj-2021-0068229
• Languages: English
• ISSNs: 0007-1447

Abstract

Abstract: 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 .