A multicentre, pragmatic patient-randomised non-inferiority trial comparing two drugs for the prevention of recurrent urinary tract infection in women both during a 12-month period of use and in the subsequent 6-months following completion of the prophylactic medication.

Overview

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30413181 protocol 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35264408/ (added 11/03/2022) 2022 Funder report results in https://pubmed.ncbi.nlm.nih.gov/35535708/ (added 11/05/2022)

Registry

who.int

Start Date

May 31, 2016

End Date

January 31, 2020

Last Updated

3 years ago

Study Type

Interventional

Sex

Female

Sponsor

•1\. Women aged 18 years and over
•2\. Women with rUTI who, in consultation with a clinician, have decided that prophylaxis is an appropriate option (to include women who have suffered at least three episodes of symptomatic UTI within the preceding 12 months or two episodes in the last 6 months or a single severe infection requiring hospitalisation)
•3\. Able to take a once daily oral dose of at least one of nitrofurantoin, or trimethoprim, or cephalexin
•4\. Able to take methenamine hippurate
•5\. Women who agree to take part in the trial but who are already taking Methenamine or antibiotic prophylaxis will be consented for participation and will stop their preventative therapy for a 3\-month washout period. They will then be reassessed and if still eligible undergo baseline assessment and randomisation
•6\. Able to give informed consent for participation in trial
•7\. Able and willing to adhere to an 18\-month study period

•1\. Women unable to take methenamine hippurate e.g. known allergy to methenamine hippurate, severe hepatic impairment (Child–Pugh class C, score of 10 or more), gout, eGFR \< 10 ml/min, Proteus sp. as consistent proven causative organism for rUTIs
•2\. Women who are unable to take nitrofurantoin and trimethoprim and cephalexin
•3\. Women with correctable urinary tract abnormalities that are considered to be contributory to the occurrence of rUTI
•4\. Presence of symptomatic UTI – this will be treated and symptoms resolved prior to randomisation.
•5\. Pregnancy or intended pregnancy in next 12 months
•6\. Women who are breast feeding
•7\. Women already taking methenamine or antibiotic prophylaxis and declining a 3\-month washout period