ALTAR
Research type
Research Study
Full title
Alternatives to prophylactic antibiotics for the treatment of recurrent urinary tract infection in women
IRAS ID
186003
Contact name
Christopher Harding
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Eudract number
2015-003487-36
Duration of Study in the UK
3 years, 8 months, 31 days
Research summary
Most women experience infective 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 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.
The study requires 120 women with rUTI, recruited from NHS hospitals across the country to be randomly allocated to each of the treatment options, either a) Once-daily low dose antibiotic for 12-months (standard treatment) or b) Methenamine hippurate a urinary antiseptic given as a tablet twice daily for 12-months.
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 of the trial will be the number of episodes of UTI reported by women in each group during the 12-months of preventative treatment. We will also record the types of bacteria found and their resistance to antibiotics.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
15/NE/0381
Date of REC Opinion
23 Dec 2015
REC opinion
Further Information Favourable Opinion