Preventing UTIs in Chronic Neurogenic Bladder Dysfunction (Mix Methods)

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.

Conditions

• UTI
• Neurogenic Bladder
• Antibiotic Resistance

Interventions

DRUG

Uro vaxom

Prevention of recurrent symptomatic lower urinary tract infections

OTHER

Placebo comparator

Placebo comparator

Sponsors & Collaborators

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• Oxford Clinical Trials Research Unit

  collaborator UNKNOWN

• Buckinghamshire Healthcare NHS Trust

  lead OTHER

Principal Investigators

• Maurizio Belci, DMS MSc MRCS FRCP · Stoke Mandeville Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-06

Primary Completion

2019-08-02

Completion

2019-09-21

Countries

• United Kingdom

Study Locations