Effect of Vaginal Estrogen on Alterations in the Urine Microbiome of Menopausal Women With Overactive Bladder

February 5, 2026 updated by: Mahidol University

A Pre-Post Quasi-Experimental Study to Evaluate the Effects of Vaginal Estrogen on the Urine Microbiome and Overactive Bladder Symptoms in Menopausal Women

The goal of this Pre-Post Quasi-experimental study is to investigates the effect of vaginal estrogen therapy on changes in the urinary microbiome and its association with improvement in overactive bladder (OAB) symptoms in menopausal women

Primary Objective:

To evaluate the effects of vaginal estrogen on the level of Lactobacillus in the urine of postmenopausal women with OAB.

Secondary Objectives

  1. To evaluate the effects of vaginal estrogen on urine microbiome in postmenopausal women with OAB.
  2. To identify the association of alterations of urine microbiome after vaginal estrogen treatment with overactive bladder symptoms.

After informed and consents process, urine samples for microbiome study will be collected from participants with sterile technique. 17β-estradiol 10 mcg will be given to the participants. The participants will be ask to use 1 tab daily for 2 weeks vaginally before bed, then 1 tab twice a week vaginally before bed until 12 weeks. Then they will come back to hospital to take urine sample for microbiome study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Overactive bladder (OAB) is a common condition affecting 12-20% of adults, particularly women in the menopausal phase. OAB is characterized by urinary urgency, frequency, nocturia, and sometimes urgency urinary incontinence, significantly impairing quality of life. Menopause is associated with a decline in estrogen levels, which affects the integrity of the lower urinary tract and may contribute to OAB symptoms.

Vaginal estrogen therapy has been used to alleviate urogenital symptoms in postmenopausal women by improving vaginal atrophy, enhancing urethral closure pressure, and potentially improving bladder function. Recent studies have suggested that the urinary microbiome plays a critical role in urinary tract health and dysfunction. Alterations in the urinary microbiome, known as dysbiosis, have been linked to conditions such as OAB, urgency urinary incontinence, and recurrent urinary tract infections.

This pre-post quasi-experimental study aims to evaluate the effects of vaginal estrogen therapy on the urinary microbiome and its association with OAB symptom improvement in menopausal women. Specifically, the study will focus on:

  1. Measuring changes in Lactobacillus abundance in urine after vaginal estrogen therapy. (Primary objective)
  2. Measuring changes in the overall urinary microbiome diversity. (Secondary objective)
  3. Identifying associations between changes in the microbiome and improvements in OAB symptoms. (Secondary objective)

The study will enroll 30 postmenopausal women with a clinical diagnosis of OAB who meet specific inclusion criteria. Participants will receive 17β-estradiol vaginal tablets (10 mcg) daily for the first two weeks, followed by twice-weekly doses for a total of 12 weeks. Urine samples will be collected via sterile catheterization at baseline and after 12 weeks to analyze microbiome diversity and Lactobacillus levels. OAB symptoms will be assessed using validated Thai versions of the Overactive Bladder Symptom Score (OABSS) and Overactive Bladder Questionnaire Short Form (OAB-q SF).

The findings from this study will provide valuable insights into the role of the urinary microbiome in the pathophysiology of OAB and the therapeutic effects of vaginal estrogen. This knowledge could pave the way for personalized treatments targeting hormonal and microbial factors in postmenopausal women with OAB.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Faculty of Medicine Ramathibodi Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Natural or surgical menopause at least 1 year
  • Present with overactive bladder symptoms by using validated Thai version of OVERACTIVE BLADDER SYMPTOM SCORE (score in No.3 ≥ 2 and overall score ≥ 3)
  • Absence of urinary infection
  • Post-void residual urine less than 100ml

Exclusion Criteria:

  • Currently or prior use of systemic hormone replacement therapy or vaginal estrogen within the past 3 months
  • Contraindication or allergy to estrogen therapy
  • Use of antibiotics, prebiotics and probiotics within the past 2 weeks
  • Currently on antimuscarinic or β3 agonists medication or within the past 3 months
  • Pelvic organ prolapse greater than stage II

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Estrogen
Participants will receive 17β-estradiol vaginal tablets (10 mcg) daily for the first two weeks, followed by twice-weekly doses for a total of 12 weeks. Participants will be asked to bring the blister pack for pill count at the 12-week follow-up (checking for compliance)
Drug: 17β-estradiol 10 mcg
17β-estradiol 10 mcg will be given to all participants. The participants will be asked to use 1 tab daily for 2 weeks vaginally before bed, then 1 tab twice a week vaginally before bed until 12 weeks
Other Names:
  • Femiest®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lactobacillus abundance
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in Lactobacillus abundance (measure by urine microbiome study) after vaginal estrogen therapy
From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in urine microbiome diversity
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in urine microbiome diversity after vaginal estrogen therapy (measured by urine microbiome study)
From enrollment to the end of treatment at 12 weeks
Association of change in urine microbiome with overactive bladder symptoms
Time Frame: From enrollment to the end of treatment at 12 weeks
Association of change in urine microbiome with overactive bladder symptoms measured by questionnaire (OAB-q SF)
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Study Chair: Jittima Manonai, MD, Ramathibodi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2025

Primary Completion (Actual)

November 10, 2025

Study Completion (Actual)

November 11, 2025

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

January 17, 2025

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MURA2024/948

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Information will be shared in de-identified data.

Research collaborators will have access to the data.

Specify that data shared with collaborators will be used for conducting analyses relevant to the study objectives, secondary analyses, or other agreed-upon purposes.

Data will be shared via a secure institutional repository accessible to collaborators through data-sharing agreements.

IPD Sharing Time Frame

Data will be shared with research collaborators upon completion of the primary analysis and will remain accessible for 5 years after the study's conclusion.

IPD Sharing Access Criteria

Only research collaborators will have access to the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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