Results
UTIs, rUTI
RECURRENCES, RECURRENCE, UTI
Of the 412 patients screened for eligibility, 376 patients were randomized equally to both groups between January 2012 and March 2015 (i.e. 188 patients per group, see Table Characteristics of patients with rUTI under prophylaxis with StroVac or placeboThe Results are presented as: mean and standard deviation (SD) and number and percent [In the StroVac group, confirmed UTIs were reduced from an average of 5.5 within 12 months prior to study enrolment to 1.2 UTIs in the 13.5 months following first injection. Apparently, the placebo group showed similar results with a reduction from 5.4 UTIs to 1.3 UTIs. Therefore, a statistically significant difference in the primary endpoint (UTI recurrences) was clearly missed (Summary of resultsUsed for calculation was the analysis set ITTPatients with non-recurrence after visit 5 in StroVac and placebo group. 86 of 188 patients after StroVac (46.0%) and 97 of 188 patients (51.6%) after placebo experienced no recurrence twelve months after study inclusion (