Efficacy of Vaginal 17β-Estradiol on the Urinary Storage Symptoms in Postmenopausal Women
Status:
COMPLETED
Trial end date:
2024-10-31
Target enrollment:
Participant gender:
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.