Effectiveness of vaginal estriol with lactobacilli on urinary symptoms in postmenopausal women: a randomized-controlled trial.

OBJECTIVE

The aim of this study was to compare the effects of a vaginal tablet containing estriol (0.03 mg) plus lactobacilli (E3/L) with placebo on lower urinary tract symptoms (LUTS) in postmenopausal women (PMW).

METHODS

This randomized, double-blinded, placebo-controlled trial was conducted at Srinagarind Hospital in Khon Kaen, Thailand. PMW with at least one LUTS, such as frequency, nocturia, dysuria, urgency, or stress or urgency urinary incontinence, were recruited. Participants were randomly assigned to receive either an E3/L tablet or placebo, administered vaginally daily at bedtime for 2 weeks, then twice a week for another 2 weeks. Symptom severity score was assessed using a visual analog scale (VAS), and quality of life (QOL) was measured using the validated Thai version of the Incontinence Impact Questionnaire-Short Form. The primary outcome was proportion of the PMW with LUTS improvement. Secondary outcomes were symptom severity score, participant satisfaction, QOL, and adverse events. Relative risk and 95% confidence intervals (CIs) were calculated using the chi-square or Fisher's exact test. An independent-sample and paired t test were used to compare means.

RESULTS

Thirty-eight participants in each group completed the study. The proportion of PMW whose symptoms improved (both in terms of most bothersome symptom and overall) did not differ significantly between the two groups. Relative risk was 1.00 (95% CI, 0.74-1.36) and 0.90 (95% CI, 0.71-1.15), respectively. There were no differences in symptom severity score, participant satisfaction, or QOL.

CONCLUSIONS

A 1-month course of vaginal E3/L does not appear to improve LUTS in PMW.