Preventing UTIs in Chronic Neurogenic Bladder Dysfunction (Mix Methods)
Status:
Completed
Trial end date:
2019-09-21
Target enrollment:
Participant gender:
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). Given that these patients with loss of bladder function do not normally feel symptoms
like pain - as would be the case in otherwise healthy persons - there is no clear agreement
among experts on which signs and symptoms are indicative of a UTI. Although strong evidence
is lacking, 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. Policy makers recently stressed the
importance of research into alternative preventative treatments. The use of immunotherapy is
one such an alternative approach, which works by stimulating the body's immune system. One of
these immunotherapy 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. Before investigating the effects of
this promising new immunotherapy, this proposed study aims to clarify two crucial issues.
First, after reviewing the literature and appraising patients', carers' and healthcare
professionals' experiences, the aim is to reach an agreement on how to measure a symptomatic
UTI in patients with loss of bladder function that results from a spinal cord lesion. Second,
using Uro-Vaxom® Investigators aim to conduct a smallscale, placebo-controlled trial with 48
participants to investigate the feasibility of carrying out a larger trial on prevention of
symptomatic UTI in such patients.
Phase:
Phase 2
Details
Lead Sponsor:
Buckinghamshire Healthcare NHS Trust
Collaborators:
National Institute for Health Research, United Kingdom Oxford Clinical Trials Research Unit