UTIPhase 2PReSuTINeBNCT02591901
Preventing UTIs in Chronic Neurogenic Bladder Dysfunction (Mix Methods)
A Phase 2 study testing Uro vaxom in people with UTI and Neurogenic Bladder, run by Buckinghamshire Healthcare NHS Trust at 2 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- UTI, Neurogenic Bladder, Antibiotic Resistance
- What is being tested?
- Uro vaxom
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 6 Apr 2018to 21 Sep 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Stoke Mandeville Hospital
Aylesbury, Buckinghamshire, HP21 8AL
Oxford Centre for Enablement
Oxford, Oxfordshire
About this study
Official title: Prevention of Recurrent Symptomatic Urinary Tract Infections in Participants With Chronic Neurogenic Bladder Dysfunction: A Mixed Method Study
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.
Read the 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.
- Conditions
- UTI, Neurogenic Bladder, Antibiotic Resistance
- Being tested
- Uro vaxom, Placebo comparator
- Keywords
- Spinal Cord Injuries, Multiple Sclerosis, Transverse Myelitis, Neurogenic Bladder Dysfunction, Feasibility Study, Urinary Tract Infection
- Medical subject headings
- Urinary Bladder, Neurogenic, Spinal Cord Injuries, Multiple Sclerosis, Myelitis, Transverse, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uro vaxomDrug
Also called OM-89
Prevention of recurrent symptomatic lower urinary tract infections
Placebo comparatorOther
Also called Placebo
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Uro Vaxom | Experimental | Uro Vaxom, Once daily for 3 months Receives: Drug: Uro vaxom |
| Placebo | Placebo comparator | Placebo identical to main drug in shape and form Receives: Other: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 23 months
Secondary outcomes (3)
Number of participants willing to participate
Measured: 14 months
Number of successfully collected urine samples via courier
Measured: 14 months
Drug compliance
Measured by the number of un-used drug packs that the participants will return upon each hospital visit
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study start6 Apr 2018
- Primary completion2 Aug 2019
- Study completion21 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for UTIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Buckinghamshire Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Oxford Clinical Trials Research Unit
- Responsible party
- Sponsor
- Investigators
- Maurizio Belci, DMS MSc MRCS FRCP, Principal investigator, Stoke Mandeville Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591901
- Sponsor's protocol ID
- RXQ/648
- Acronym
- PReSuTINeB
- Status last verified
- Mar 2020
- First submitted
- 27 Oct 2015
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Esclarin De Ruz A, Garcia Leoni E, Herruzo Cabrera R. Epidemiology and risk factors for urinary tract infection in patients with spinal cord injury. J Urol. 2000 Oct;164(4):1285-9.
PubMed 10992382D'Hondt F, Everaert K. Urinary tract infections in patients with spinal cord injuries. Curr Infect Dis Rep. 2011 Dec;13(6):544-51. doi: 10.1007/s11908-011-0208-6.
PubMed 21853416Manack A, Motsko SP, Haag-Molkenteller C, Dmochowski RR, Goehring EL Jr, Nguyen-Khoa BA, Jones JK. Epidemiology and healthcare utilization of neurogenic bladder patients in a US claims database. Neurourol Urodyn. 2011 Mar;30(3):395-401. doi: 10.1002/nau.21003. Epub 2010 Sep 29.
PubMed 20882676Street JT, Noonan VK, Cheung A, Fisher CG, Dvorak MF. Incidence of acute care adverse events and long-term health-related quality of life in patients with TSCI. Spine J. 2015 May 1;15(5):923-32. doi: 10.1016/j.spinee.2013.06.051. Epub 2013 Aug 24.
PubMed 23981816Morawietz C, Moffat F. Effects of locomotor training after incomplete spinal cord injury: a systematic review. Arch Phys Med Rehabil. 2013 Nov;94(11):2297-308. doi: 10.1016/j.apmr.2013.06.023. Epub 2013 Jul 9.
PubMed 23850614Lavy C, James A, Wilson-MacDonald J, Fairbank J. Cauda equina syndrome. BMJ. 2009 Mar 31;338:b936. doi: 10.1136/bmj.b936. No abstract available.
PubMed 19336488Gupta A, Taly AB, Srivastava A, Murali T. Non-traumatic spinal cord lesions: epidemiology, complications, neurological and functional outcome of rehabilitation. Spinal Cord. 2009 Apr;47(4):307-11. doi: 10.1038/sc.2008.123. Epub 2008 Oct 21.
PubMed 18936767West TW. Transverse myelitis--a review of the presentation, diagnosis, and initial management. Discov Med. 2013 Oct;16(88):167-77.
PubMed 24099672Rubin SM. Management of multiple sclerosis: an overview. Dis Mon. 2013 Jul;59(7):253-60. doi: 10.1016/j.disamonth.2013.03.012. No abstract available.
PubMed 23786659Ersoz M, Tunc H, Akyuz M, Ozel S. Bladder storage and emptying disorder frequencies in hemorrhagic and ischemic stroke patients with bladder dysfunction. Cerebrovasc Dis. 2005;20(5):395-9. doi: 10.1159/000088670. Epub 2005 Oct 3.
PubMed 16205058Benevento BT, Sipski ML. Neurogenic bladder, neurogenic bowel, and sexual dysfunction in people with spinal cord injury. Phys Ther. 2002 Jun;82(6):601-12.
PubMed 12036401Jamison J, Maguire S, McCann J. Catheter policies for management of long term voiding problems in adults with neurogenic bladder disorders. Cochrane Database Syst Rev. 2013 Nov 18;2013(11):CD004375. doi: 10.1002/14651858.CD004375.pub4.
PubMed 24249436Sedor J, Mulholland SG. Hospital-acquired urinary tract infections associated with the indwelling catheter. Urol Clin North Am. 1999 Nov;26(4):821-8. doi: 10.1016/s0094-0143(05)70222-6.
PubMed 10584622Khatri B, Basnyat S, Karki A, Poudel A, Shrestha B. Etiology and antimicrobial susceptibility pattern of bacterial pathogens from urinary tract infection. Nepal Med Coll J. 2012 Jun;14(2):129-32.
PubMed 23671963Cai T, Mazzoli S, Mondaini N, Meacci F, Nesi G, D'Elia C, Malossini G, Boddi V, Bartoletti R. The role of asymptomatic bacteriuria in young women with recurrent urinary tract infections: to treat or not to treat? Clin Infect Dis. 2012 Sep;55(6):771-7. doi: 10.1093/cid/cis534. Epub 2012 Jun 7.
PubMed 22677710
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Recurrent Symptomatic Urinary Tract Infections in Participants With Chronic Neurogenic Bladder Dysfunction: A Mixed Method Study
- ClinicalTrials.gov ID
- NCT02591901
- Acronym / sponsor ID
- PReSuTINeB / RXQ/648
- Conditions
- UTI, Neurogenic Bladder, Antibiotic Resistance
- Keywords
- Spinal Cord Injuries, Multiple Sclerosis, Transverse Myelitis, Neurogenic Bladder Dysfunction, Feasibility Study, Urinary Tract Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Buckinghamshire Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Oxford Clinical Trials Research Unit
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 21 Sep 2019 (actual)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uro Vaxom | Experimental | Drug: Uro vaxomUro Vaxom, Once daily for 3 months |
| Placebo | Placebo comparator | Other: Placebo comparatorPlacebo identical to main drug in shape and form |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uro vaxomAlso: OM-89Prevention of recurrent symptomatic lower urinary tract infections | Drug | Uro Vaxom |
| Placebo comparatorAlso: PlaceboPlacebo comparator | Other | Placebo |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Background: PubMed 10992382Esclarin De Ruz A, Garcia Leoni E, Herruzo Cabrera R. Epidemiology and risk factors for urinary tract infection in patients with spinal cord injury. J Urol. 2000 Oct;164(4):1285-9.
- Background: PubMed 21853416D'Hondt F, Everaert K. Urinary tract infections in patients with spinal cord injuries. Curr Infect Dis Rep. 2011 Dec;13(6):544-51. doi: 10.1007/s11908-011-0208-6.
- Background: PubMed 20882676Manack A, Motsko SP, Haag-Molkenteller C, Dmochowski RR, Goehring EL Jr, Nguyen-Khoa BA, Jones JK. Epidemiology and healthcare utilization of neurogenic bladder patients in a US claims database. Neurourol Urodyn. 2011 Mar;30(3):395-401. doi: 10.1002/nau.21003. Epub 2010 Sep 29.
- Background: PubMed 23981816Street JT, Noonan VK, Cheung A, Fisher CG, Dvorak MF. Incidence of acute care adverse events and long-term health-related quality of life in patients with TSCI. Spine J. 2015 May 1;15(5):923-32. doi: 10.1016/j.spinee.2013.06.051. Epub 2013 Aug 24.
- Background: PubMed 23850614Morawietz C, Moffat F. Effects of locomotor training after incomplete spinal cord injury: a systematic review. Arch Phys Med Rehabil. 2013 Nov;94(11):2297-308. doi: 10.1016/j.apmr.2013.06.023. Epub 2013 Jul 9.
- Background: PubMed 19336488Lavy C, James A, Wilson-MacDonald J, Fairbank J. Cauda equina syndrome. BMJ. 2009 Mar 31;338:b936. doi: 10.1136/bmj.b936. No abstract available.
- Background: PubMed 18936767Gupta A, Taly AB, Srivastava A, Murali T. Non-traumatic spinal cord lesions: epidemiology, complications, neurological and functional outcome of rehabilitation. Spinal Cord. 2009 Apr;47(4):307-11. doi: 10.1038/sc.2008.123. Epub 2008 Oct 21.
- Background: PubMed 24099672West TW. Transverse myelitis--a review of the presentation, diagnosis, and initial management. Discov Med. 2013 Oct;16(88):167-77.
- Background: PubMed 23786659Rubin SM. Management of multiple sclerosis: an overview. Dis Mon. 2013 Jul;59(7):253-60. doi: 10.1016/j.disamonth.2013.03.012. No abstract available.
- Background: PubMed 16205058Ersoz M, Tunc H, Akyuz M, Ozel S. Bladder storage and emptying disorder frequencies in hemorrhagic and ischemic stroke patients with bladder dysfunction. Cerebrovasc Dis. 2005;20(5):395-9. doi: 10.1159/000088670. Epub 2005 Oct 3.
- Background: PubMed 12036401Benevento BT, Sipski ML. Neurogenic bladder, neurogenic bowel, and sexual dysfunction in people with spinal cord injury. Phys Ther. 2002 Jun;82(6):601-12.
- Background: PubMed 24249436Jamison J, Maguire S, McCann J. Catheter policies for management of long term voiding problems in adults with neurogenic bladder disorders. Cochrane Database Syst Rev. 2013 Nov 18;2013(11):CD004375. doi: 10.1002/14651858.CD004375.pub4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurizio Belci, DMS MSc MRCS FRCP principal investigator
Stoke Mandeville Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Uro vaxom in people with UTI and Neurogenic Bladder, run by Buckinghamshire Healthcare NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02591901, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.