Background and Study Aim

Background and study aims

Most women experience infective cystitis (otherwise known as urinary tract infection or 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 suppressing the infecting bacteria, it has side effects and sometimes 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 mostly to advise antibiotics. The ALTAR trial aims to compare one such alternative non-antibiotic prevention for rUTI, a drug called methenamine hippurate, against the current standard of daily low dose antibiotic to see if the methenamine is at least as good at preventing UTI and has fewer side effects, particularly a lower chance of resistant bacteria developing.

Who can participate?

Women aged at least 18 with rUTI.

What does the study involve?

The participants are randomly allocated to one of 2 groups. Those in group 1 are given a low dose antibiotic once a day for 12 months. Those in group 2 are given methenamine hippurate, a urinary antiseptic given as a tablet, twice a day for 12-months. Each participant is followed 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. They are all asked to provide urine samples at the start of their time on the study and then every 3 months until the end of their participation in the study (18 months later). If a participant suffers from a UTI during the study , they are asked to provide an additional urine sample to determine the type of bug causing the infection. Blood samples are taken at the start of the study, and then at 3 months, 6 months, 9 months and 12 months. Participants may be asked provide an additional sample at 18 months depending on the results of the previous tests. Skin swabs taken from the area near the anus are also take from each participant at the start of the study and then every 6 months until the end of their participation in the study at 18 months. Participants are also asked to complete questionnaires on the number of infections the participants have had and what effect this has had on their general health. The questionnaires also measure the impact the infection and treatment is having on the participant’s life in terms of cost and benefit. They are completed at the start of the study and at 3, 6, 9, 12, 15 and 18 months during the study. Participants are given a diary to use to keep a record of any urinary infections as they happen to make completing the questionnaires easier.

What are the possible benefits and risks of participating?

During the trial participants will be under closer follow-up than normal and will learn more about their problem from the information they are given. It is uncertain which treatment will work best and this is why we are doing the study. Participants will be helping to improve the treatment of urinary infections and enabling us to get essential information which will benefit future patients with repeated urinary infections.

The disadvantage of randomisation is that participants will not be able to choose between the two methods of preventative treatment (Hiprex® or antibiotic) for their recurrent urinary infections; some people may see this as a disadvantage. Participants should be prepared to have either option for the year of the treatment period of the study. In addition it is usual practice to stop preventative treatment (Hiprex® or antibiotic) after 12 months and we have built this into the study design. Participants will be monitored for 6 months following completion of treatment. This will allow us to find out if the effects are prolonged when the treatment stops. We also advise people with health insurance to check if taking part in this study affects them in any way.

Where is the study run from?

Seven NHS hospitals in the UK

When is the study starting and how long is it expected to run for?

February 2016 to November 2019

Who is funding the study?

National Institute for Health Research (UK)