Efficacy of Vaginal 17β-Estradiol on the Urinary Storage Symptoms in Postmenopausal Women

Summary

The goal of this clinical trial is to evaluate whether vaginal 17β-estradiol effectively treats storage symptoms of lower urinary tract symptoms (LUTS) and enhances quality of life. The main questions it aims to answer are: * What is the efficacy of vaginal 17β-estradiol treatment compared to placebo in alleviating storage symptoms of LUTS? * How does vaginal 17β-estradiol treatment affect the urethral maturation index and vaginal pH compared to placebo? * What impact does vaginal 17β-estradiol treatment have on overall quality of life and patients' perception of global improvement (PGI)? Participants in the trial will undergo the following procedures: * Screening procedures at the first visit to exclude correctable causes of LUTS and to complete a bladder diary. * Visit the clinic at 1-2 weeks for a review of the bladder diary and a check-up. Participants will receive the assigned dosage of vaginal 17β-estradiol or placebo: one vaginal tablet daily for two weeks, followed by one vaginal tablet twice a week for 10 weeks. * The third and fourth visits (at 4 and 12 weeks after treatment) will involve: completion of bladder diaries, questionnaires, vaginal pH testing, collection of urethral maturation index (UMI), observation of intervention's side effects and monitoring of LUTS symptoms.

Timeline

Start

2024-04-08

Primary completion

2024-10-22

Completion

2024-10-31

Publications

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Drugs

Indications