Plain English Summary
Background and study aims
Patients suffering from neurological conditions (conditions of the nervous system) that affect the spinal cord, such as spinal cord injury or multiple sclerosis, may encounter loss of bladder control. This in turn can lead to the development of serious urinary tract infections (UTIs). Although strong evidence is lacking, antibiotics have been widely used for prevention of recurrent UTIs in these patients. However, this approach is now being questioned as antibiotic resistance (in which the bacteria causing the infection are no longer killed by the antibiotics) has become a world-wide health concern. Policy makers recently stressed the importance of research into alternative preventative treatments. For example the use of vaccines, which work by stimulating the body’s immune system so that it can fight the infection itself. One of these vaccines is ro-Vaxom®, a pill which contains inactivated traces of the bacteria that normally causes UTIs in patients with loss of bladder control. Previous studies show that Uro-Vaxom® led to a significant reduction of UTIs in otherwise healthy patients, as well as being safe to use. This study is made up of two stages. In the first stage, the aim is to reach an agreement on how best to measure a symptomatic (symptom causing) UTI in patients with loss of bladder function due to spinal cord damage. In the second stage the aim is to conduct a small study on 48 patients into the effectiveness of Uro-Vaxom® in order to find out whether a larger scale study would be possible.
Who can participate?
Adults with a who have had a neurological condition for at last one year and have had at least three symptomatic UTIs in the last year which have required treatment with antibiotics.
What does the study involve?
In the first stage of the study, 24 participants attend an interview and are asked to fill out questionnaires about their experiences and quality of life in relation to loss of bladder control and urinary tract infections. In the second stage of the study, 48 participants are randomly allocated to one of two groups. Those in the first group take Uro-Vaxom® capsules once a day for 90 days and those in the second group take an identical looking placebo (dummy pill) once a day for 90 days. At the start of the study and then again after one, three and six months, participants in both groups complete a number of questionnaires about their experiences of UTIs, as well as providing urine and blood samples. During the six months of the study, all participants keep a study diary, detailing their ongoing experiences of potential UTIs during that time.
What are the possible benefits and risks of participating?
There is a possibility that participants taking the Uro-Vaxom® may benefit from a reduction in the amount of UTIs they have. In the second stage of the study, there is a very small risk that participants taking Uro-Vaxom® may experience side effects including flu-like symptoms, headache or heartburn. There is also a small risk that participants may experience pain or bruising during and after blood testing.
Where is the study run from?
1. Stoke Mandeville Hospital (UK)
2. Oxford Centre for Enablement (UK)
3. Reading Royal Berkshire Hospital (UK)
4. Rayners Hedge Community Neuro-Rehab Unit (UK)
When is the study starting and how long is it expected to run for?
January 2016 to December 2018
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
1. Dr Sen Selvarajah (public)
sen.selvarajah@buckshealthcare.nhs.uk
2. Dr Julian Taylor (scientific)
julian.taylor@smsr.org.uk
Trial website
Contact information
Type
Public
Primary contact
Dr Sen Selvarajah
ORCID ID
Contact details
Stoke Mandeville Spinal Research (SMSR)
Mandeville Road
Aylesbury
Bucks
HP21 8AL
National Spinal Injuries Center | Mandeville Road | Aylesbury | HP21 8AL
Aylesbury
HP218AL
United Kingdom
+44 1296 418140
sen.selvarajah@buckshealthcare.nhs.uk
Type
Scientific
Additional contact
Dr Julian Taylor
ORCID ID
Contact details
Sensorimotor Function Group
Hospital Nacional de Parapléjicos
Finca "La Peraleda"
Toledo
45071
Spain
+34 692163048
juliantaylorgreen2@gmail.com
Additional identifiers
EudraCT number
2015-003913-12
ClinicalTrials.gov number
NCT02591901
Protocol/serial number
RXQ/648
Study information
Scientific title
Prevention of Recurrent Symptomatic Urinary Tract Infections in Participants with Chronic Neurogenic Bladder Dysfunction: A Mixed Method Study (The PReSUTINeB Study)
Acronym
The PReSuTINeB Study
Study hypothesis
The aim of this study is to investigate the feasibility of carrying out a larger definitive randomised controlled trial on prevention of symptomatic UTI in patients with chronic neurogenic bladder dysfunction using Uro-Vaxom.
Ethics approval
London Harrow Ethics Committee, 02/03/2016, ref: 15/LO/2069
Study design
Multi-centre prospective randomised placebo-controlled feasibility trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Please see additional files
Condition
Urinary tract infections in patients with neurogenic bladder dysfunction
Intervention
Stage one:
Participants will be interviewed and will be asked to fill out questionnaires which will take approximately one hour. The questionnaires can be filled out either online, via mail, or as a direct interview (based on preference). The interviews and questionnaires will be used to collect information about experiences and quality of life in relation to loss of bladder control and urinary tract infections.
Stage two:
Participants will be randomly allocated (1:1) to the two treatment groups via a central remote computer-based allocation randomisation system provided by the Oxford Clinical Trials Research Unit (OCTRU) using a non-deterministic minimization algorithm to ensure treatment concealment and balanced allocation of participants across the two treatment groups for centre and method of bladder management. The service may be accessed by both telephone (during normal office hours, 8 am to 5 pm), or via a secure randomisation website (24 hours / 7 days a week).
Intervention arm: Participants are treated with Uro-Vaxom® (6mg lyophilised Escherichia coli bacterial lysate per capsule) once a day for 90 days.
Control arm: Participants are treated with a matching placebo once a day for 90 days.
Participants in both groups are provided with a Study Booklet to fill in details about any potential urinary tract infections during the six month study and vials for the collection of urine samples (if a urinary tract infection is suspected). At 1, 3 and 6 months, participants attend follow up appointments lasting for approximately one hour, at which questionnaires are completed and blood and urine samples collected.
Intervention type
Drug
Phase
Phase III/IV
Drug names
Uro-Vaxom
Primary outcome measure
Study feasibility is determined by recording the recruitment rate for each part of the study and through patient feedback questionnaires completed at baseline, 3 and 6 months
Secondary outcome measures
1. Urinary tract infection rate is determined using the study booklet (completed from baseline-six months) and interviews at baseline, 1, 3 and 6 months
2. Compliance to the study drug is measured through examining drug blister packs at 3 months
3. Species and amount of bacteria in urine is measured using a urine culture and sensitivity test at baseline, 1, 3 and 6 months
Overall trial start date
04/01/2016
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years to 75 years
2. At least one year post onset of neurological condition and now living in the community
3. Neurological status stable for past 9 months, as confirmed by treating physician
4. NBD due to SCI, CES, TM or M
5. Suffered at least three symptomatic UTI within previous twelve months requiring antibiotic course of treatment
6. Able to provide Written Informed Consent and complete study procedures
7. For women able and willing to use contraception during study participation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
48 (24 participants in stage 1, who are eligible to take part in stage 2)
Participant exclusion criteria
1. Having a microbiologically confirmed symptomatic infection at time of randomisation.
2. Use of antibiotics within 14 days of study screening.*
3. Use of immunosuppressant medication (e.g. anti-rejection drugs, oral or intramuscular steroids or chemotherapy).
4. Involvement in any other IMP related clinical trial within 24 weeks of screening (Screening Visit 1).
5. Surgical intervention of the urinary tract (i.e cystoscopy) 2 months prior to study recruitment.
6. Women who are pregnant or intending to become pregnant or who are breast feeding
7. Known hypersensitivity to any known ingredients in Uro-Vaxom
*Recruitment can be postponed until antibiotics have not been used for a period of 14 days.
Recruitment start date
01/08/2016
Recruitment end date
01/03/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Stoke Mandeville Hospital
National Spinal Injuries Centre (NSIC)
Aylesbury
HP218AL
United Kingdom
Trial participating centre
Oxford Centre for Enablement
Nuffield Orthopaedic Centre
Old Road
Headington
Oxford
OX3 7HE
United Kingdom
Trial participating centre
Reading Royal Berkshire Hospital
Craven Road
Reading
RG15AN
United Kingdom
Trial participating centre
Rayners Hedge Community Neuro-Rehab Unit
Croft Road
Aylesbury
HP217RD
United Kingdom
Sponsor information
Organisation
Buckinghamshire Healthcare NHS Trust
Sponsor details
R&D office
Stoke Mandeville Hospital
Mandeville Road
Aylesbury
HP218AL
Aylesbury
HP218AL
United Kingdom
01296 316200
denise.watson@buckshealthcare.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
unknown
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results will be disseminated at the end of each stage of the study respectively
Plans for the publication will be split in terms of the psychological component of the study for stage 1 to present the analysis regarding signs and symptoms of UTI is in relation to patients, healthcare professionals and caregivers. This is intended for the summer of 2017. Once the main part of the clinical finishes with regard to Uro-Vaxom we hope to publish in the autumn of 2018.
Intention to publish date
31/12/2019
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2019 protocol in https://www.ncbi.nlm.nih.gov/pubmed/30992071 (added 05/08/2019)
Publication citations
Additional files
- ISRCTN11666384_PIS_26Feb16_Stage2_V4.docx Uploaded 10/05/2016
- ISRCTN11666384_PIS_01Mar16_Stage1_V5.docx Uploaded 10/05/2016