Ignite Creation Date:
2024-05-06 @ 7:46 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02591901
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2015-10-27
Brief Title:
Preventing UTIs in Chronic Neurogenic Bladder Dysfunction Mix Methods
Sponsor:
Buckinghamshire Healthcare NHS Trust
Organization:
Buckinghamshire Healthcare NHS Trust
Study Overview
Official Title:
Prevention of Recurrent Symptomatic Urinary Tract Infections in Participants With Chronic Neurogenic Bladder Dysfunction A Mixed Method Study
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PReSuTINeB
Brief 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 bodys 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
Detailed Description:
Each year in the UK 1200 people sustain a spinal cord injury 600 people will be diagnosed with cauda equina syndrome 6000 with multiple sclerosis and 300 with transverse myelitis These four patient groups all suffer from neurological disorders of the spinal cord resulting in loss of normal bladder function known as neurogenic bladder dysfunction This in turn can lead to urinary tract infections UTIs UTIs are a commonly recurring and debilitating complication with spinal patients experiencing 25 episodes per patient per year on average This not only results in 16 of hospital readmissions and costs of care of up to 125 million spent by the NHS on treating UTIs every year but also has a dramatic impact on patients quality of life
A recent NICE guideline highlighted the methodological difficulties of research into the prevention of UTIs in patients with neurogenic bladder dysfunction Given that this group of patients normally do not feel symptoms like pain and a frequent urge to urinate it can be difficult to distinguish between bladder colonisation asymptomatic bacteriuria and true infection a symptomatic UTI To date there is no clear agreement among experts on which signs and symptoms are indicative of a symptomatic UTI Although strong evidence is lacking antibiotics have been widely used for the prevention of recurrent UTIs in patients with neurogenic bladder dysfunction However this approach is now being called into question as antibiotic resistance has become a world-wide health concern
In the recently published UK Five Year Antimicrobial Resistance Strategy policy makers stressed the importance of research into alternative preventative treatments Immunotherapy potentially offers such a cost- effective alternative to antibiotic therapy for UTI management At least 83 of community-acquired complicated UTIs are caused by Escherichia coli E coli Uro-Vaxom OM-Pharma Switzerland is an orally administered bacterial vaccine which consists of a 6mg lyophilised heat-inactivated mix of E coli membrane glycoproteins
Previous studies showed that Uro-Vaxom resulted in a significant reduction of UTIs in otherwise healthy women with recurrent cystitis as well as being safe to use
Before investigating the effects of this promising new vaccine in patients with neurogenic bladder dysfunction two crucial issues will need to be clarified First consensus must be reached on how to measure a symptomatic UTI in this group of patients Second the feasibility of carrying out a larger definitive randomised controlled trial on the prevention of symptomatic UTI in patients with neurogenic bladder dysfunction must be established The central aim of the proposed mixed method study is to clarify these two key methodological and feasibility issues
In the first stage of this study is to carry out qualitative interviews to explore patient experiences and views of symptoms and signs associated with a UTI These results combined with findings from a literature review will enable the design of a quantitative patient survey which will be distributed by four service user organisations to people with neurogenic bladder dysfunction Finally taking the results from all preceding stages a final definition or algorithm will be discussed before and during a consensus meeting
In the second stage of this study a small-scale parallel double-blinded randomised placebo-controlled multicentre trial will be conducted to investigate the feasibility of carrying out a larger well-powered study on the prevention of symptomatic UTI in patients with neurogenic bladder dysfunction Forty-eight patients will be randomly assigned treatment with Uro-Vaxom or placebo for 3 months and followed-up for a further 3 months
This is to expose any pitfalls or areas requiring re-designing such as logistics recruitment and compliance rates in order to refine the protocol of a definitive clinical trial
A recent NICE guideline highlighted the methodological difficulties of research into the prevention of UTIs in patients with neurogenic bladder dysfunction Given that this group of patients normally do not feel symptoms like pain and a frequent urge to urinate it can be difficult to distinguish between bladder colonisation asymptomatic bacteriuria and true infection a symptomatic UTI To date there is no clear agreement among experts on which signs and symptoms are indicative of a symptomatic UTI Although strong evidence is lacking antibiotics have been widely used for the prevention of recurrent UTIs in patients with neurogenic bladder dysfunction However this approach is now being called into question as antibiotic resistance has become a world-wide health concern
In the recently published UK Five Year Antimicrobial Resistance Strategy policy makers stressed the importance of research into alternative preventative treatments Immunotherapy potentially offers such a cost- effective alternative to antibiotic therapy for UTI management At least 83 of community-acquired complicated UTIs are caused by Escherichia coli E coli Uro-Vaxom OM-Pharma Switzerland is an orally administered bacterial vaccine which consists of a 6mg lyophilised heat-inactivated mix of E coli membrane glycoproteins
Previous studies showed that Uro-Vaxom resulted in a significant reduction of UTIs in otherwise healthy women with recurrent cystitis as well as being safe to use
Before investigating the effects of this promising new vaccine in patients with neurogenic bladder dysfunction two crucial issues will need to be clarified First consensus must be reached on how to measure a symptomatic UTI in this group of patients Second the feasibility of carrying out a larger definitive randomised controlled trial on the prevention of symptomatic UTI in patients with neurogenic bladder dysfunction must be established The central aim of the proposed mixed method study is to clarify these two key methodological and feasibility issues
In the first stage of this study is to carry out qualitative interviews to explore patient experiences and views of symptoms and signs associated with a UTI These results combined with findings from a literature review will enable the design of a quantitative patient survey which will be distributed by four service user organisations to people with neurogenic bladder dysfunction Finally taking the results from all preceding stages a final definition or algorithm will be discussed before and during a consensus meeting
In the second stage of this study a small-scale parallel double-blinded randomised placebo-controlled multicentre trial will be conducted to investigate the feasibility of carrying out a larger well-powered study on the prevention of symptomatic UTI in patients with neurogenic bladder dysfunction Forty-eight patients will be randomly assigned treatment with Uro-Vaxom or placebo for 3 months and followed-up for a further 3 months
This is to expose any pitfalls or areas requiring re-designing such as logistics recruitment and compliance rates in order to refine the protocol of a definitive clinical trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None