Homeopathic prophylaxis for recurrent urinary tract infections following spinal cord injury: study protocol for a randomized controlled trial

Background: Virtually many patients with spinal cord injury (SCI) suffer from neurogenic lower urinary tract dysfunction (NLUTD). Although the most severe consequence of NLUTD, damage of renal function, can be treated effectively today, urinary tract infections (UTI) are the most common urologic problems in SCI patients. They severely impair the quality of life, and no evidence-based prophylaxis exists. The goal of this study is to assess the usefulness of adjunctive homeopathic treatment for the reduction of UTI in patients with SCI. Methods/Design: A prospective randomized controlled trial is designed to assess whether adjunctive treatment with classical homeopathy leads to a relevant reduction of the rate of UTI in patients with SCI. In addition, it will be assessed if homeopathic treatment will significantly improve patient satisfaction and quality of life. Fifty patients with SCI and recurrent (3 or more) UTI per year will be recruited from the patients of the neuro-urology of the Swiss paraplegic Centre in Nottwil, Switzerland. All patients will be randomly allocated into two groups: patients in the homeopathy group (n = 25) will receive standard of-care prophylaxis combined with homeopathic treatment; the control group (n = 25) will receive standard of-care prophylaxis alone. Standard of-care prophylaxis consists of cranberry products and urine acidification. Homeopathic treatment consists of a homeopathic medication; the remedy is chosen individually based on the homeopathic case taking. Patients do not routinely present to the homeopaths during the study, but can contact them if a UTI occurs during the course of the study. Primary outcome are the UTI rate, and secondary outcomes are quality of life and satisfaction with the treatment over a follow-up period of 1 year. Discussion: There is a high demand for effective UTI prophylaxis in patients with SCI, because UTI are associated with an increased morbidity and even mortality. The results of the study will significantly add to our knowledge not only about UTI prevention, but the clinical value of homeopathy. Trial registration: ClinicalTrials.gov identifier: NCT01477502, registered on 17 November 2011. Ethics: The "Ethikkommission Nordwest- und Zentralschweiz (EKNZ): PB_2016-00054" approved this study protocol. Informed consent: Patients will sign an informed consent prior to participation in the study.