References
incontinence, mellitus, Overactive Bladder, NRS
INCONTINENCE, OVERACTIVE BLADDER, INCONTINENCE, UTI, URINARY INCONTINENCE, URINARY TRACT INFECTION
A schematic representation of the study design. Screening was scheduled approximately two weeks before the baseline visit, at which time, if the women decided to participate, they were asked to answer the ICIQ questionnaires to ensure eligibility. Before baseline and follow-up visits, the women were asked to fill out diaries. On the visit days (day 0 baseline and day 90 follow-up), a catheterized urine sample was collected, and questionnaires were filled in. At the baseline visit, the women were randomized and allocated to receive either the RCE or the placebo formulation. ICIQ: International Consultation on Incontinence Questionnaire; RCE: red clover extract.Consort participant flowchart of participation through the present study. UTI: urinary tract infection; RCE: red clover extract.International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) score at baseline and follow-up for RCE (International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) results from questions 3a (International Consultation on Incontinence Questionnaire Urinary Incontinence (ICIQ-UI) score at baseline and follow-up for RCE (Baseline health-demographic characteristics of the study participants according to randomization group.Never smokedFormer smokerSmokerFormer smokerSmokerWetDryUrgeUrge and stressStress No urinary incontinenceLichen sclerosusProlapsDiabetes mellitus 2HypothyroidismPercentages are calculated based on either the total or within each treatment group. Comparison of patient-reported symptom bother (NRS values) from the ICIQ-OAB questionnaire.NRS values are median (QR1−QR3). The NRS to monitor the bother of the symptom ranges from 0 (not at all) to 10 (a great deal). The comparison from baseline to follow-up was analyzed using the paired samples Wilcoxon test. Fluid intake and urinary voiding information as reported by the women in the study diary in accordance with trial randomization status.Mean ± SD are stated for normally distributed data, whereas median (QR1–QR3) values are stated for not normally distributed data. All volumes are in mL. * One woman did not complete the fluid intake and voiding diary at follow-up and was therefore excluded from the analysis. ** Two women did not report incontinence episodes and were therefore excluded from the analysis of incontinence. The comparison from baseline to follow-up was analyzed using the paired 