Study design, materials and methods
This was a prospective, longitudinal observational before-and-after study conducted between June 2022 and September 2024, following approval by the local ethics committee. Each participant served as their own historical control, with the number of symptomatic UTI episodes recorded during the year before bacterial autovaccine treatment compared with the number recorded during the year after treatment.
The study included two assessment phases. In the initial phase, epidemiological data, SCI-related variables, and the number of symptomatic UTI episodes during the previous year were recorded. In the final phase, the number of symptomatic UTI episodes during the year after treatment was documented, and participants completed the Spanish version of the BSW questionnaire (Benefit, Satisfaction and Willingness).
Eligible participants were adults aged over 18 years, without cognitive impairment, with chronic SCI of more than 2 years’ duration, and with a history of at least 3 symptomatic UTI episodes in the previous year despite preventive measures. All participants agreed to receive bacterial autovaccine treatment, attended an educational session, and provided written informed consent.
Statistical analysis was performed using Stata version 14.0. Quantitative variables were summarised using mean, standard deviation and median, whereas qualitative variables were presented as frequencies. Comparisons were performed at a 95% confidence level.
Interpretation of results
In this cohort of adults with chronic SCI and recurrent symptomatic UTI episodes despite preventive measures, bacterial autovaccine treatment was associated with a significant reduction in infection frequency during follow-up compared with the year before treatment, with each participant acting as their own control. The observed decrease in the annual number of symptomatic UTI episodes suggests a potential beneficial effect of this approach in a population with a high infectious burden and limited therapeutic alternatives. Patient-reported benefit and satisfaction, as reflected by the BSW questionnaire, were overall favourable.