Endpoints
bacterial UTIs, UTIs
RECURRENCES, RECURRENCE
The primary endpoint was the number of bacterial UTIs over 13.5 months after randomization adjusted by the respective “baseline” value (ITT-population) when comparing verum and placebo group. Baseline adjustment was done by including the respective baseline value as covariate into the statistical model. Secondary endpoints were defined as the number of UTIs within 12 months observation period (visits V5–V9), number of patients with non-recurrence during the entire study period, time to first recurrence, and frequency of recurrences during the first 6 months vs. months 7–12 after finalisation of the immunization scheme. Furthermore, patients' self-assessment and quality of life were measured using a validated questionnaire compiled from EUROHIS-QOL-Score [