Dataset Information

Immunotherapy to reduce frequency of urinary tract infections in people with neurogenic bladder dysfunction; a pilot randomised, placebo-controlled trial.

ABSTRACT:

Objective

To establish the feasibility of a randomized, placebo-controlled trial to investigate the effect of a specific immunotherapy bacterial lysate OM-89 (Uro-Vaxom^®) in reducing the frequency of urinary tract infections in people with neurogenic bladder dysfunction.

Design

A parallel-group, double-blind, randomized, placebo-controlled trial.

Setting

Patients at home, recruited through out-patient contact, social media and patient support groups.

Subjects

People with a spinal cord injury, multiple sclerosis, transverse myelitis or cauda equina syndrome who had suffered three or more clinically diagnosed urinary tract infections treated with antibiotics over the preceding 12 months.

Interventions

All participants took one capsule of oral OM-89 immunotherapy (6 mg) or matching Placebo (randomisation ratio 1:1), once daily in the morning for 3 months.

Main measures

The primary outcome was occurrence of a symptomatic urinary tract infection treated with an antibiotic, assessed at 3 and 6 months. Feasibility measures included recruitment, retention and practical difficulties.

Results

Of 115 patients screened, 49 were recruited, one withdrew before randomization, and 23 were allocated to the control group receiving matching placebo. Six participants, all in the control group, discontinued the intervention; all participants provided full data at both follow-up times. Over 6 months, 18/25 active group patients had 55 infections, and 18/23 control group patients had 47 infections. Most research and clinical procedures were practical, and acceptable to participants.

Conclusion

It is feasible to undertake a larger trial. We recommend broader inclusion criteria to increase eligibility and generalizability.

SUBMITTER: Wade DT

PROVIDER: S-EPMC7649953 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description: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.

Project description:BackgroundSacral neuromodulation has become a well-established and widely accepted treatment for refractory non-neurogenic lower urinary tract dysfunction, but its value in patients with a neurological cause is unclear. Although there is evidence indicating that sacral neuromodulation may be effective and safe for treating neurogenic lower urinary tract dysfunction, the number of investigated patients is low and there is a lack of randomized controlled trials.Methods and designThis study is a prospective, randomized, placebo-controlled, double-blind multicenter trial including 4 sacral neuromodulation referral centers in Switzerland. Patients with refractory neurogenic lower urinary tract dysfunction are enrolled. After minimally invasive bilateral tined lead placement into the sacral foramina S3 and/or S4, patients undergo prolonged sacral neuromodulation testing for 3-6 weeks. In case of successful (defined as improvement of at least 50% in key bladder diary variables (i.e. number of voids and/or number of leakages, post void residual) compared to baseline values) prolonged sacral neuromodulation testing, the neuromodulator is implanted in the upper buttock. After a 2 months post-implantation phase when the neuromodulator is turned ON to optimize the effectiveness of neuromodulation using sub-sensory threshold stimulation, the patients are randomized in a 1:1 allocation in sacral neuromodulation ON or OFF. At the end of the 2 months double-blind sacral neuromodulation phase, the patients have a neuro-urological re-evaluation, unblinding takes place, and the neuromodulator is turned ON in all patients. The primary outcome measure is success of sacral neuromodulation, secondary outcome measures are adverse events, urodynamic parameters, questionnaires, and costs of sacral neuromodulation.DiscussionIt is of utmost importance to know whether the minimally invasive and completely reversible sacral neuromodulation would be a valuable treatment option for patients with refractory neurogenic lower urinary tract dysfunction. If this type of treatment is effective in the neurological population, it would revolutionize the management of neurogenic lower urinary tract dysfunction.Trial registrationTrial registration numberhttp://www.clinicaltrials.gov; Identifier: NCT02165774.

Project description:ObjectiveInappropriate diagnosis and treatment of asymptomatic bacteriuria (ASB) and urinary tract infection (UTI) are leading causes of antibiotic overuse but have not been well-studied in patients with risks for complicated UTI such as neurogenic bladder (NB). Our aim was to describe ASB and UTI management in patients with NB and assess factors associated with inappropriate management.DesignRetrospective cohort study.SettingFour Department of Veteran's Affairs (VA) medical centers.ParticipantsAdults with NB due to spinal cord injury/disorder (SCI/D), multiple sclerosis (MS), or Parkinson disease (PD) and encounters with an ASB or UTI diagnosis between 2017 and 2018. Clinical and encounter data were extracted from the VA Corporate Data Warehouse and medical record reviews for a stratified sample of 300 encounters from N=291 patients.InterventionsNone.Main outcome measuresPrevalence of appropriate and inappropriate ASB and UTI diagnosis and treatment was summarized. Multivariable logistic regression models assessed factors associated with inappropriate management.ResultsN=200 UTI and N=100 ASB encounters were included for the 291 unique patients (SCI/D, 39.9%; MS, 36.4%; PD, 23.7%). Most patients were men (83.3%), >65 years (62%), and used indwelling or intermittent catheterization (68.3%). Nearly all ASB encounters had appropriate diagnosis (98%). 70 (35%) UTI encounters had inappropriate diagnosis, including 55 (27.5%) with true ASB, all with inappropriate treatment. Among the remaining 145 UTI encounters, 54 (27%) had inappropriate treatment. Peripheral vascular disease, chronic kidney disease, and cerebrovascular disease were associated with increased odds of inappropriate management; indwelling catheter (aOR 0.35, P=.01) and Physical Medicine & Rehabilitation provider (aOR 0.29, P<.01) were associated with decreased odds.ConclusionUp to half of UTI encounters for patients with NB had inappropriate management, largely due to inappropriate UTI diagnosis in patients with true ASB. Interventions to improve ASB and UTI management in patients with NB should target complex patients with comorbidities being seen by non-rehabilitation providers.