Recruitment closed JANUARY 2019
Trial Status: Under Analysis
A randomized placebo-controlled study in patients with neurogenic bladder dysfunction and recurrent urinary tract infections (UTIs)
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).
There is strong evidence on the effectiveness of antibiotics as treatment for symptomatic UTIs. Although strong evidence of its effectiveness is lacking, antibiotics have also been widely used for prevention of recurrent UTIs in patients with loss of bladder function. Antimicrobial resistance (AMR) has now become a world-wide health concern and policy makers recently stressed the importance of research into alternative preventative treatments.
The use of immunotherapy is another approach, which works by using certain parts of a persons immune system to fight infections. One immunotherapy option is Uro-Vaxom® oral capsule which consists of which consists of bacterial lysates that work as Pathogen-associated molecular patterns (PAMPs). Previous studies show that Uro-Vaxom® resulted in a significant reduction of UTIs in otherwise healthy patients, as well as being well tolerated.
The PReSUTINeB investigators will investigate if Uro Vaxom can reduce the incidence of symptomatic UTIs in 48 participants in two centres in the UK (Stoke Mandeville Hospital, Buckinghamshire and Oxford Centre for Enablement). The investigators will also look at the signs and symptoms experienced when a participant experiences during a symptomatic UTI.
Sponsor: Buckinghamshire Healthcare NHS Trust
Funder: National Institute Health Research
Chief Investigator: Mr Nigel Henderson
Research Project Manager: Mr James Cooper
Ethics Ref: 15-LO-2069
IRAS Number: 185760
ClinicalTrials.gov ID: NCT0251901
NIHR Number: PB-PG-1013-32017
The study protocol publication can be found here.