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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

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, recruit...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group Ltd. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8905684/
https://www.ncbi.nlm.nih.gov/pubmed/35264408
http://dx.doi.org/10.1136/bmj-2021-0068229
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author 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
author_facet 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
author_sort Harding, Chris
collection PubMed
description 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.
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spelling pubmed-89056842022-03-25 Alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, non-inferiority trial 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 BMJ Research 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. BMJ Publishing Group Ltd. 2022-03-09 /pmc/articles/PMC8905684/ /pubmed/35264408 http://dx.doi.org/10.1136/bmj-2021-0068229 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Research
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
Alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, non-inferiority trial
title Alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, non-inferiority trial
title_full Alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, non-inferiority trial
title_fullStr Alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, non-inferiority trial
title_full_unstemmed Alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, non-inferiority trial
title_short Alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, non-inferiority trial
title_sort alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, non-inferiority trial
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8905684/
https://www.ncbi.nlm.nih.gov/pubmed/35264408
http://dx.doi.org/10.1136/bmj-2021-0068229
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