MedTrace Logo

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

NCT06780163 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-09

No results posted yet for this study

Summary

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.

Conditions

  • Overactive Bladder (OAB)
  • Menopause
  • Microbiome

Interventions

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

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Jittima Manonai, MD · Ramathibodi Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-27
Primary Completion
2025-11-10
Completion
2025-11-11

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06780163 on ClinicalTrials.gov