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.

Conditions

• Lower Urinary Tract Symptoms
• Female Genitourinary Disease
• Urinary Stress Incontinence
• Urinary Urge Incontinence
• Nocturia
• Quality of Life
• Voiding Disorders
• Vagina Atrophy
• Urethral Atrophy
• Overactive Bladder
• Overactive Bladder Syndrome
• Bladder, Overactive

Interventions

DRUG

vaginal 17 beta-estradiol

* 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.

DRUG

Placebo

* 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

Behavioral modifications

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.

Sponsors & Collaborators

• Mahidol University

  lead OTHER

Principal Investigators

• Pornthip Harncharoenkul, MD · Ramathibodi Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-08

Primary Completion

2024-10-22

Completion

2024-10-31

Countries

• Thailand

Study Locations