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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
UTI Neurogenic Bladder Antibiotic Resistance Drug: Uro vaxom Other: Placebo comparator Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Recurrent Symptomatic Urinary Tract Infections in Participants With Chronic Neurogenic Bladder Dysfunction: A Mixed Method Study
Actual Study Start Date : April 6, 2018
Actual Primary Completion Date : August 2, 2019
Actual Study Completion Date : September 21, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Uro Vaxom
Uro Vaxom, Once daily for 3 months
 Drug: Uro vaxom
Prevention of recurrent symptomatic lower urinary tract infections
Other Name: OM-89
Placebo Comparator: Placebo
Placebo identical to main drug in shape and form
 Other: Placebo comparator
Placebo comparator
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Number of participants willing to participate [ Time Frame: 14 months ]
  2. Number of successfully collected urine samples via courier [ Time Frame: 14 months ]
  3. Drug compliance [ Time Frame: 14 months ]
    Measured by the number of un-used drug packs that the participants will return upon each hospital visit


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02591901


Locations
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United Kingdom
Stoke Mandeville Hospital
Aylesbury, Buckinghamshire, United Kingdom, HP21 8AL
Oxford Centre for Enablement
Oxford, Oxfordshire, United Kingdom
Sponsors and Collaborators
Buckinghamshire Healthcare NHS Trust
National Institute for Health Research, United Kingdom
Oxford Clinical Trials Research Unit
Investigators
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Principal Investigator: Maurizio Belci, DMS MSc MRCS FRCP Stoke Mandeville Hospital
More Information
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Publications:
Plowman, R., Graves, N., Griffin, M., Swan, A., Cookson, B., Taylor, L. 1999. The socio-economic burden of healthcare associated infection. PHLS.
NICE guidelines: Urinary incontinence in neurological disease: Management of lower urinary tract dysfunction in neurological disease. https://www.nice.org.uk/guidance/cg148/chapter/1-guidance
Richie, J. and Spencer, L. Qualitative data analysis for applied policy research. In Analysing Qualitative Data. (eds A.Bryman and R.Burgess). 1994:173-194. London: Routledge

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Responsible Party: Buckinghamshire Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT02591901    
Other Study ID Numbers: RXQ/648
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Buckinghamshire Healthcare NHS Trust:
Spinal Cord Injuries
Multiple Sclerosis
Transverse Myelitis
 Neurogenic Bladder Dysfunction
Feasibility Study
Urinary Tract Infection
Additional relevant MeSH terms:
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Urinary Tract Infections
Urinary Bladder, Neurogenic
Infections
Urologic Diseases
 Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases