Efficacy of vaginal 17β-estradiol on the urinary storage symptoms in postmenopausal women: a randomized double-blind, placebo-controlled study

Abstract

This randomized, double-blind, placebo-controlled trial evaluated the efficacy of vaginal 17β-estradiol (10 mcg) in alleviating storage symptoms of lower urinary tract symptoms (LUTS) in postmenopausal women. A total of 86 participants were randomized to receive either vaginal 17β-estradiol or placebo for 12 weeks, with both groups undergoing standardized behavioral modifications. The primary outcome, improvement in storage symptoms assessed using ICIQ-FLUTS, showed no significant difference between groups at 12 weeks (IRR: 1.28, 95% CI: 0.57–1.98; p = 0.441). However, urgency significantly improved in the intervention group at 4 weeks (mean difference: -0.47, 95% CI: -0.90 to -0.04; p = 0.033) but was not sustained. Urgency urinary incontinence (UUI) showed a consistent benefit, with significant improvement at both 4 and 12 weeks (p = 0.013). Secondary outcomes showed trends favoring the intervention group. PGI-I scores were significantly better in the intervention group at 4 weeks (p = 0.035) but were comparable to the placebo group at 12 weeks. Urethral maturation index (UMI) improved at 4 weeks (p < 0.001) and remained higher than the placebo group at 12 weeks (p = 0.007). Vaginal pH significantly decreased at both time points (p < 0.001) in the intervention group. The treatment was well tolerated, with minimal adverse effects. While vaginal 17β-estradiol may provide short-term urgency relief and sustained UUI improvement, further studies are needed to confirm long-term efficacy.