Between October 2016 and September 2018 210 women were included in this trial, of which 204 participants completed the study. These women, 102 in each arm, were included for primary analysis. Baseline characteristics were similar in both arms for age, postmenopausal status, body mass index (BMI), ethnicity and delivery in history. In the placebo group more women experienced a UTI in the past year (table 1). Most performed surgeries were anterior repair, posterior repair, sacrospinous ligament fixation (SSF), separately or in combination. Significantly more SSFs were performed in the control group: 60,8% versus 44,1% in the intervention group (p=0,02). Peri-operative complications were similar in both groups, 0 in the cranberry group and 2,7% in the placebo group (p=0,08). Postoperative urinary retention was also not significantly different (11,8% versus 10,8% respectively, p=0,83).
There was no significant difference in primary endpoint, the clinical diagnosis of UTI between the cranberry arm (n=13, 12,7%) and the placebo arm (n=21, 20,6%; p=0,13). No significant difference was found in growth in urine cultures, respectively 8,8% and 13,7% (p=0,27). Compliance to treatment protocol was high (88,2% and 82,4% respectively) and not significantly different between both arms. There were no differences in reported serious adverse events, nor in side effects, respectively 8,8% and 7,8% (p=0,90). Reported side effects were mostly gastrointestinal. In the cranberry group one women experienced allergic reaction of the skin.