CompletedPhase 2

Preventing UTIs in Chronic Neurogenic Bladder Dysfunction (Mix Methods)

United Kingdom48 participantsStarted 2018-04-06

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion Criteria: * Have a clinical diagnosis of spinal cord injury, multiple sclerosis, transverse myelitis or cauda equina damage; * Have had the diagnosis of the spinal pathology for at least 12 months; * Have not had any significant changes in the underlying condition for 12 weeks * Be living in the community (not in residential care) * Aged 18 to 75 years * Have had at least three urinary tract infection episodes treated using anti-biotics over the preceding 12 months; * If a woman of child-bearing age, is willing to use contraception for the duration of the study * Having the mental capacity to give informed consent Exclusion Criteria: * Have had surgical alterations to the bladder, excluding supra-pubic catherisation. * Known hypersensitivity to the active principle or to any of the excipients of Uro-Vaxom® * Being unwilling to take a product containing gelatin (e.g. vegetarians) * recruitment can be postponed until antibiotics have not been used for a period of 14 days and symptoms of a UTI have subsided

What they're measuring

Checklist or consensus guideline which can be used to measure a symptomatic urinary tract infection and Practicality of carrying out a definitive randomised controlled clinical study

Timeframe: 23 months

Trial details

NCT IDNCT02591901

SponsorBuckinghamshire Healthcare NHS Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-08-02