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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02591901
Recruitment Status : Unknown
Verified October 2015 by Buckinghamshire Healthcare NHS Trust.
Recruitment status was:  Not yet recruiting
First Posted : October 30, 2015
Last Update Posted : October 30, 2015
Information provided by (Responsible Party):
Buckinghamshire Healthcare NHS Trust

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 vaccines is one such an alternative approach, which works by stimulating the body's immune system. One of these vaccines 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 vaccine, 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 Drug: Uro vaxom Other: Placebo comparator Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : January 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Uro Vaxom
Uro Vaxom, Once daily for 3 months
Drug: Uro vaxom
Prevention of recurrent 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

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

Information from the National Library of Medicine

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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

Inclusion Criteria:

  • NBD due to SCI, CES, TM or MS
  • at least one year post onset of neurological condition and now living in the community
  • neurological stable for the past 9 months as confirmed by treating physician Male or Female, aged 18 to 75 years
  • Suffered at least 3 symptomatic UTI within the previous 12 months requiring antibiotic treatment
  • Able to provide written informed consent and complete study procedures
  • For women able and willing to use contraception ( e.g contraceptive pill or transdermal patch, spermicide and barrier, intrauterine device, or implants during study participation

Exclusion Criteria:

  • Having a microbiologically confirmed symptomatic infection at the time of randomisation
  • Use of antibiotics within 14 days of study screening*
  • Use of immunosuppressant medication e.g anti rejection drugs
  • Involvement in any other IMP related clinical trial within 24 weeks of screening
  • Surgical intervention of the urinary tract 2 months prior to study recruitment
  • Women who are pregnant or breast-feeding
  • Known hypersensitivity to Ny known ingredients of Uro-Vaxom

    • recruitment can be postponed until antibiotics have not been used for a period of 14 days

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 identifier (NCT number): NCT02591901

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Contact: Senthooran Selvarajah, PhD 10296 418140
Contact: Julian Taylor, PhD 01296 316783

Sponsors and Collaborators
Buckinghamshire Healthcare NHS Trust
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Study Director: Nigel Henderson, MBBS Stoke Mandeville Hospital

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.
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 Identifier: NCT02591901     History of Changes
Other Study ID Numbers: RXQ/648
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: October 30, 2015
Last Verified: October 2015
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
Urologic Diseases
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Signs and Symptoms