Journal Article


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 randomised, 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, randomised, 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 (6mg) or matching Placebo (randomisation ratio 1:1), once daily in the morning for three months. Main measures. The primary outcome was occurrence of a symptomatic urinary tract infection treated with an antibiotic, assessed at three and six months. Feasibility measures included recruitment, retention and practical difficulties. Results. Of 115 patients screened, 49 were recruited, one withdrew before randomisation, 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 six 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 generalisability.

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Authors

Wade, Derick T
Cooper, James
Peckham, Nicholas
Belci, Maurizio

Oxford Brookes departments

Department of Sport, Health Sciences and Social Work

Dates

Year of publication: 2020
Date of RADAR deposit: 2020-07-13


Creative Commons License This work is licensed under a Creative Commons Attribution 4.0 International License


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