Abstract
BackgroundPatients 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.MethodsThis 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.DiscussionHealthcare 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.Trial registrationISRTCN. 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.
Highlights
Patients with lower neurogenic bladder dysfunction are at an increased risk of suffering from recurrent urinary tract infections
Secondary aim To investigate the symptoms associated with Urinary tract infection (UTI) that require antibiotic treatment, and how consistently they are reported in an individual participant
Symptoms associated with UTIs, and how consistently they are reported by an individual participant compliance with: ◦ protocol, e.g. attending follow-up and completing questionnaires ◦ taking Uro-Vaxom® in oral capsule form adverse events
Summary
Study history The original protocol was registered at ClinicalTrials.Gov in October 2015 (NCT02591901) and the first part of the study, unrelated to the interventional phase administration of Uro-Vaxom®, began in April 2016. The secondary clinical outcome measures are: symptoms associated with UTIs, and how consistently they are reported by an individual participant compliance with: ◦ protocol, e.g. attending follow-up and completing questionnaires ◦ taking Uro-Vaxom® in oral capsule form adverse events (including serious adverse events). The primary statistical analysis will be carried out on the basis of intention-to-treat, with all participants being analysed according to their allocated treatment group irrespective of which treatment they receive As this is a feasibility study and is not statistically powered for hypothesis testing, analysis will be descriptive in nature and will focus on confidence interval estimation in order to provide key data parameters for the larger, definitive trial. Data will be analysed once complete data collection, entry and validation is achieved
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