VESPER
Research type
Research Study
Full title
INTRAVESICAL PREPARATIONS FOR RECURRENT URINARY TRACT INFECTION PREVENTION (THE VESPER TRIAL): A MULTI-ARM, MULTI-SITE OPEN LABEL RANDOMISED SUPERIORITY TRIAL
IRAS ID
1011153
Contact name
Christopher Harding
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN68263889
Research summary
Most women experience urine infections during their lifetime, but some get repeated episodes, which considerably reduce quality of life. This is known as recurrent urinary tract infection (rUTI) and is defined as at least two episodes in six months or three in a year. rUTI is a very common reason for antibiotic prescription. Overuse and misuse of antibiotics drives increased antimicrobial resistance, which is a critical global health threat. Daily, low-dose, oral antibiotics for up to 6 months is the standard preventative treatment for rUTI however they do not work for some women. Patients with infections that are difficult to control may need treatment given directly into the bladder through the urethra (water pipe) using a very thin disposable single use catheter (known as bladder instillations). Patients usually receive these treatments over 6-months. Currently, about 75% of surveyed urology specialists report regular use of instillations but the supporting evidence for these treatments is lacking, and current clinical guidelines can only recommend more (second line) daily oral antibiotics.
The VESPER randomised controlled trial compares two treatments given directly into the bladder: intravesical gentamicin and intravesical glycosaminoglycan (GAG) preparations to prevent UTI against the current recommended treatment of daily oral second-line antibiotics. Women seen in a hospital urology/urogynaecology clinic with rUTI who have not improved after first-line treatments will be invited to participate.
We will compare the number of UTI episodes occurring in each group during the 6-months of treatment to see which treatment is best at preventing UTI. We will follow-up each woman during the trial and record UTI occurrence as well as the benefits, side effects and costs of treatment. We will record the types of bacteria found and their resistance to antibiotics. The trial is funded by National Institute for Health Research Health Technology Assessment programme.REC name
Wales REC 1
REC reference
24/WA/0358
Date of REC Opinion
7 Jan 2025
REC opinion
Further Information Favourable Opinion