2.4. Outcomes, Co-Variables and Statistical Methods

The outcomes considered in this study were: (1) number of UTI diagnoses within 12 months after the Utipro^® Plus prescription compared to 12 months prior to Utipro^® Plus prescription, (2) number of antibiotic prescriptions within 12 months after the Utipro^® Plus prescription compared to 12 months before Utipro^® Plus prescription, and (3) number of days of sick leave due to UTI within 12 months after the Utipro^® Plus prescription compared to 12 months prior to Utipro^® Plus prescription. For each patient, the time point of the first Utipro^® Plus prescription was considered the index date.

Descriptive statistics (involving mean value and standard deviation) were performed for continuous variables and the total number of patients (N) and the relative frequencies (%) were obtained for the categorical parameters. Demographic variables included age as a continuous variable, including age groups 18–30, 31–40, 41–50, 51–60, 61–70, and >70 years; sex; and health insurance coverage (private or statutory). Co-diagnoses documented within 12 months before or on the index date included hypertension (I10), diabetes mellitus (E10–E14), obesity (E66), lipid metabolism disorders (E78), ischemic heart diseases (I20–I25), heart failure (I50), stroke/TIA (I63, I64, G45), renal failure (N18, N19), Parkinson’s Disease (G21,G22), dementia (F00–F03, G30), and chronic bronchitis or chronic obstructive pulmonary disease (COPD) (J42–J44).

Differences in the outcomes before vs. after the Utipro^® Plus prescription were first descriptively tested using Wilcoxon tests for paired samples. These comparisons were performed separately for women, men, and defined age groups. p-values < 0.05 were considered statistically significant. Analyses were carried out using SAS version 9.4 (SAS institute, Cary, NC, USA).