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Preventing UTIs in Chronic Neurogenic Bladder Dysfunction (Mix Methods) (PReSuTINeB)

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ClinicalTrials.gov Identifier: NCT02591901
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : March 18, 2020
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
Oxford Clinical Trials Research Unit
Information provided by (Responsible Party):
Buckinghamshire Healthcare NHS Trust

Tracking Information
First Submitted Date  ICMJE October 27, 2015
First Posted Date  ICMJE October 30, 2015
Last Update Posted Date March 18, 2020
Actual Study Start Date  ICMJE April 6, 2018
Actual Primary Completion Date August 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2015)
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 [ Time Frame: 23 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2015)
  • Number of participants willing to participate [ Time Frame: 14 months ]
  • Number of successfully collected urine samples via courier [ Time Frame: 14 months ]
  • Drug compliance [ Time Frame: 14 months ]
    Measured by the number of un-used drug packs that the participants will return upon each hospital visit
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preventing UTIs in Chronic Neurogenic Bladder Dysfunction (Mix Methods)
Official Title  ICMJE Prevention of Recurrent Symptomatic Urinary Tract Infections in Participants With Chronic Neurogenic Bladder Dysfunction: A Mixed Method Study
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 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.
Detailed Description

Each year in the UK 1,200 people sustain a spinal cord injury, 600 people will be diagnosed with cauda equina syndrome, 6,000 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 2.5 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • UTI
  • Neurogenic Bladder
  • Antibiotic Resistance
Intervention  ICMJE
  • Drug: Uro vaxom
    Prevention of recurrent symptomatic lower urinary tract infections
    Other Name: OM-89
  • Other: Placebo comparator
    Placebo comparator
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: Uro Vaxom
    Uro Vaxom, Once daily for 3 months
    Intervention: Drug: Uro vaxom
  • Placebo Comparator: Placebo
    Placebo identical to main drug in shape and form
    Intervention: Other: Placebo comparator
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2015)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 21, 2019
Actual Primary Completion Date August 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02591901
Other Study ID Numbers  ICMJE RXQ/648
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Buckinghamshire Healthcare NHS Trust
Study Sponsor  ICMJE Buckinghamshire Healthcare NHS Trust
Collaborators  ICMJE
  • National Institute for Health Research, United Kingdom
  • Oxford Clinical Trials Research Unit
Investigators  ICMJE
Principal Investigator: Maurizio Belci, DMS MSc MRCS FRCP Stoke Mandeville Hospital
PRS Account Buckinghamshire Healthcare NHS Trust
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP