The PReSUTINeB Study (v1.0).
Research type
Research Study
Full title
Prevention of Recurrent Symptomatic Urinary Tract Infections in Patients with Chronic Neurogenic Bladder Dysfunction: A mixed Method Study (The PReSUTINeB Study).
IRAS ID
185760
Contact name
James Cooper
Contact email
Sponsor organisation
Stoke Mandeville Hospital
Eudract number
2015-003913-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 27 days
Research summary
Due to the damage caused to the spinal cord, patients with spinal cord injury, cauda equina syndrome, multiple sclerosis and transverse myelitis may encounter loss of bladder function, which in turn can lead to a debilitating and costly complication: Urinary Tract Infections (UTIs).
Antibiotics have been widely used for prevention of recurrent UTIs in patients with loss of bladder function. However, this approach is now being questioned as antibiotic resistance has become a world-wide health concern. The use of vaccines is an alternative approach, which works by stimulating the body’s immune system. One of these vaccines is a Uro-Vaxom® oral capsule which consists of inactivated traces of the bacteria that normally cause at least 83% of UTIs in patients with loss of bladder function. Previous studies show that Uro-Vaxom® resulted in a significant reduction of UTIs in otherwise healthy patients, as well as being safe to use.
Here, we aim to conduct a small-scale, double-blinded, randomised placebo-controlled trial with 48 participants using Uro-Vaxom® to investigate the feasibility of carrying out a larger definitive randomised controlled trial on prevention of symptomatic UTI in such patients. Participants will be outpatients with a spinal cord injury, cauda equina syndrome, multiple sclerosis or transverse myelitis and as a result will have loss of normal bladder function. Study participants will be randomly assigned to take either a Uro-Vaxom® or matching placebo capsule every morning for three months and will then be followed up for a further three months. During this trial, participants will provide urine and blood samples on three study visits (beginning of study, after three months and after 6 months). This is for safety monitoring reasons and for detection of any bacteria present in the urine.
REC name
London - Harrow Research Ethics Committee
REC reference
15/LO/2069
Date of REC Opinion
1 Mar 2016
REC opinion
Further Information Favourable Opinion