We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Uro-Vaxom® versus placebo for the prevention of recurrent symptomatic urinary tract infections in participants with chronic neurogenic bladder dysfunction: a randomised controlled feasibility study.
- Authors
Wade, Derick; Cooper, James; Derry, Fadel; Taylor, Julian
- Abstract
<bold>Background: </bold>Patients with lower neurogenic bladder dysfunction are at an increased risk of suffering from recurrent urinary tract infections. Recurrent symptomatic urinary tract infection is occasionally treated with antibiotics as a prophylactic prevention strategy. This risks increasing the frequency of antibiotic resistance. National healthcare policymakers have requested further research into alternative preventive measures for pathologies that require antibiotic treatment.<bold>Methods: </bold>This study protocol describes a two-centre, randomised, double-blinded, placebo-controlled study to evaluate the prevention of recurrent urinary tract infections with the commercial immunotherapy agent Uro-Vaxom®, based on Escherichia coli pathogen-associated molecular patterns. Eligible participants are recruited by the direct healthcare team and randomised to receive Uro-Vaxom® in the form of an oral capsule, or a matching placebo. Participants will receive the study treatment daily for 3 months and followed up for an additional 3 months so that the number of symptomatic urinary tract infection episodes and individual signs and symptoms per episode can be recorded using participant study diaries. Primary outcome measures are: number of symptomatic urinary tract infections experienced over 3 months, number of symptomatic urinary tract infections experienced over 6 months, time from the start of treatment to the first urinary tract infection, and the presence of asymptomatic bacteriuria at 3 and 6 months. Secondary outcome measures are: individually recorded symptoms normally associated with recurrent urinary tract infection and consistency of reported symptoms during the symptomatic urinary tract infection experienced during the study, compliance with study protocol and study medication, and adverse events.<bold>Discussion: </bold>Healthcare policymakers recommend that alternative preventative strategies are identified for symptomatic urinary tract infections that require antibiotic treatment. If Uro-Vaxom® is shown to be effective, this feasibility study would warrant a larger, statistically powered, multicentre study to investigate whether this immunotherapy strategy is an effective preventative measure for recurrent symptomatic urinary tract infection for people with spinal cord injuries and neurological pathologies.<bold>Trial Registration: </bold>ISRTCN. Registered on 30 October 2015. ClinicalTrials.gov, ID: NCT0251901 . Registered on 30 October 2015. URL of trial registry record: Ethics Ref: 15-LO-2069. IRAS Number: 185760. Sponsor Number: RXQ/648. NIHR Funding Reference: PB-PG-1013-32017.
- Subjects
ESCHERICHIA coli; URINARY tract infections; CAUDA equina; MULTIPLE sclerosis; TRANSVERSE myelitis; ANTI-infective agents; URINARY tract infection prevention; CHRONIC diseases; IMMUNOMODULATORS; COMPARATIVE studies; LONGITUDINAL method; RESEARCH methodology; MEDICAL cooperation; NEUROGENIC bladder; HEALTH outcome assessment; RESEARCH; RESEARCH ethics; STATISTICS; DISEASE relapse; PILOT projects; DATA analysis; EVALUATION research; RANDOMIZED controlled trials; BLIND experiment; DISEASE complications; THERAPEUTICS
- Publication
Trials, 2019, Vol 20, Issue 1, pN.PAG
- ISSN
1745-6215
- Publication type
journal article
- DOI
10.1186/s13063-019-3275-x