Authors' objectives: Most women experience cystitis (otherwise known as urinary tract infection; UTI) at least once in their life and some get repeated episodes which are uncomfortable and stressful this is known as recurrent urinary tract infection (rUTI) and affects around 300,000 women each year in the UK. Giving long term low dose antibiotics is the most frequently used prevention for rUTI and although reasonably effective at supressing the infecting bacteria, they have side effects and causes bacteria to become resistant to antibiotics. There are some alternative preventative options for rUTI that don t involve antibiotics but doctors are unsure how well they work and so tend to mostly advise antibiotics. The ALTAR trial aims to compare one such alternative non-antibiotic prevention for rUTI, a drug called methanamine hippurate, against the current standard of daily low dose antibiotic to see if the methanamine is at least as good at preventing UTI and has less side effects, particularly a lower chance of resistant bacteria developing. The preventative treatments to be compared are: 1. Once-daily low dose antibiotic for 12-months (standard) 2. Methanamine hippurate, a urinary antiseptic given as a tablet twice daily for 12-months For the trial, women seeking help for rUTI who are seen in a hospital urology clinic at one of our study centres will be given information about the study and asked if they would like to take part. For women that do decide to take part, their preventative therapy (methanamine or antibiotic) will be decided at random by a computer programme, similar to a toss of a coin. The reason for this is that it is the only way to guarantee a fair comparison between two options. We will follow each woman during the 12-months that they take the UTI prevention and then for 6 months afterwards to record the benefits, side effects and costs of each treatment. The main outcome that we will use to decide the result will be the number of episodes of UTI women in each group suffer during the 12-months of preventative treatment. We will also record the types of bacteria found and their resistance to antibiotics. Throughout the study women will be able to have the usual short course of treatment antibiotics for any episodes of UTI that they suffer. To carry out the study successfully we will need 255 women to take part and we have planned the study to be completed in 45 months. The main problem that we think women may find during the study is if they don t get any benefit from the prevention treatment that they are allocated. We have designed the study so we can quickly find this out mainly by planned regular contact with participants. We have taken into account the need for some women to have to switch to another prevention treatment during the first 12 months. This study is trying to help solve an important problem with our current overuse of antibiotics which is causing more and more resistant bacteria and so difficult to treat infections. We have assembled a team of clinical trial experts and enthusiastic doctors from large NHS centres. The funding requested is needed to pay the staff to do the study and provide the resources required to collect and process the outcome information. If the study does show that methanamine is as good as antibiotic at preventing UTI it will result in substantial NHS savings related to lower bacterial resistance levels and less hard to treat infections.

Project Status: Ongoing

URL for project: http://www.nets.nihr.ac.uk/projects/hta/138821

Anticipated Publish Date: 2021

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

Copyright: Queen's Printer and Controller of HMSO