At a glance
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Efficacy of Vaginal 17β-Estradiol on the Urinary Storage Symptoms in Postmenopausal Women: A Randomized Double-Blind, Placebo-Controlled Study
In Brief
A Phase 4 clinical trial evaluating vaginal 17 beta-estradiol, Placebo, and 1 other intervention for Lower Urinary Tract Symptoms and 11 related conditions. Completed, enrolled 86 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
* Femiest® Haupt Pharma Munster GMBH, Muenster, Germany * The assigned dosage will be one vaginal tablet daily for two weeks then one vaginal tablet twice a week for 10 weeks.
* Placebo is produced by Chulalongkorn University Drug and Health Products Innovation \& Promotion Center. * The assigned dosage will be one vaginal tablet daily for two weeks then one vaginal tablet twice a week for 10 weeks.
Behavioral modifications for women with storage symptoms of lower urinary tract symptoms (LUTS) involve strategies such as regulating fluid intake, avoiding bladder irritants, practicing bladder training techniques (scheduled and delayed voiding), performing pelvic floor muscle exercises, managing weight, increasing dietary fiber, maintaining a bladder diary, setting a regular voiding schedule, utilizing stress management techniques, and educating patients about LUTS.