Preventing UTIs in Chronic Neurogenic Bladder Dysfunction (Mix Methods)

NCT02591901 | Completed Phase 2

• 1 other identifier: RXQ/648
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

UTI; Neurogenic Bladder; Antibiotic Resistance

Keywords

Spinal Cord Injuries; Multiple Sclerosis; Transverse Myelitis; Neurogenic Bladder Dysfunction; Feasibility Study; Urinary Tract Infection

Outcome Measures

Primary Outcomes (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

  23 months

Secondary Outcomes (3)

• Number of participants willing to participate

  14 months

• Number of successfully collected urine samples via courier

  14 months

• Drug compliance

  14 months

Study Arms (2)

Uro Vaxom

EXPERIMENTAL

Uro Vaxom, Once daily for 3 months

Drug: Uro vaxom

Placebo

PLACEBO COMPARATOR

Placebo identical to main drug in shape and form

Other: Placebo comparator

Interventions

Uro vaxom DRUG

Prevention of recurrent symptomatic lower urinary tract infections

Also known as: OM-89

Uro Vaxom

Placebo comparator OTHER

Placebo comparator

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Buckinghamshire Healthcare NHS Trust: lead
• National Institute for Health Research, United Kingdom: collaborator
• Oxford Clinical Trials Research Unit: collaborator

Study Sites (2)

Stoke Mandeville Hospital

Aylesbury, Buckinghamshire, HP21 8AL, United Kingdom

Location

Oxford Centre for Enablement

Oxford, Oxfordshire, United Kingdom

Location

Related Publications (32)

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  BACKGROUND

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MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Spinal Cord Injuries; Multiple Sclerosis; Myelitis, Transverse; Urinary Tract Infections

Interventions

OM 89

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Myelitis; Central Nervous System Infections; Infections; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Neurodegenerative Diseases; Neuroinflammatory Diseases

Study Officials

• Maurizio Belci, DMS MSc MRCS FRCP

  Stoke Mandeville Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: October 30, 2015
• Study Start: April 6, 2018
• Primary Completion: August 2, 2019
• Study Completion: September 21, 2019
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

GB (2)