About our Project

Antibiotic Treatment for Intermittent Bladder Catheterisation: A Randomised Controlled Trial of Once Daily Prophylaxis (The AnTIC study)

 Background and study aims

This research project is designed to find out whether people who suffer repeated urinary tract infections (UTI) related to the need to empty their bladders intermittently with a fine plastic tube (catheter); a process called clean intermittent self-catheterisation (CISC), benefit from taking continuous daily low-dose antibiotics (antibiotic prophylaxis). We estimate that about 40,000 people in the UK need to use CISC regularly to empty their bladder either because of nerve damage such as multiple sclerosis or because of failure of the bladder muscle to contract, and of these about 25% (10,000 people) suffer frequent UTI. One way to reduce this problem may be to take a small daily dose of antibiotics and the study aims to find out whether such treatment is effective and worthwhile both for the people who suffer the problem and for the NHS.

We have assembled a team involving experts in carrying out such a trial, and doctors from seven large NHS centres across the UK. The two options to be compared in the trial are firstly, a once daily preventive dose (prophylaxis) of an antibiotic routinely used for this purpose (either nitrofurantoin or trimethoprim or cefalexin), and secondly no prophylaxis.   We think that an overall decrease of 20% or more in the frequency of UTI would be large enough for future patients using CISC who get troublesome recurrent UTIs to be offered antibiotic prophylaxis routinely. We will also assess any harm caused by continuous use of antibiotics, particularly side effects for those people taking them and changes in the resistance of bacteria to these antibiotics. We can then work out whether the balance between the benefits and harms make the use of prophylaxis worthwhile to people carrying out CISC and for the NHS as a whole.

Who can participate?

Adults aged 18 or over from across the UK who are regular CISC-users can participate if they have suffered at least two UTIs within the past year, or at least one episode of UTI requiring hospitalisation.

What does the study involve?

Participants must be willing to have one of the two alternative treatments randomly chosen for them by computer and take part with the intention to continue with the chosen treatment for 12 months. Participants who are given prophylaxis will be able to swap between the three antibiotics during the 12 months. We will then measure the number of urinary infections suffered by participants in each group and compare the results statistically to see if UTIs are less frequent amongst people taking antibiotic prophylaxis, and if so, whether the benefit is sufficiently noticeable to be important and useful to patients and the NHS.

We will be asking participants in the study to fill in a diary and make sure that they send a urine specimen to the laboratory whenever they feel they have an infection. We will also ask them to complete questionnaires every three months and send routine urine specimens when they join the study and again after six and 12 months together, if separately agreed, with swabs of the perineal area. We will also ask some participants to volunteer to fill in an additional questionnaire and be interviewed by telephone at the end of their participation in the trial.

Having to do all this may be quite onerous for some participants who have other health problems or disabilities. We will ensure, by regular contact that members of the research team will be on hand to help when needed and also, in consultation with our patient co-applicant, adapt arrangements where possible to suit individual capabilities. Our team of clinical and scientific experts together with a knowledgeable patient have the skills and experience to successfully complete the study.