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

Launched by MAHIDOL UNIVERSITY · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how vaginal estrogen therapy might change the bacteria in the urine of menopausal women who have overactive bladder (OAB) symptoms. The main goal is to see if using vaginal estrogen can increase the levels of a type of healthy bacteria called Lactobacillus in the urine, and how this might help improve OAB symptoms. If you are a postmenopausal woman experiencing OAB symptoms and have not used hormone therapy in the last three months, you might be eligible to participate in this study.

Participants will be asked to use a small tablet of vaginal estrogen daily for two weeks, and then twice a week for a total of 12 weeks. After this period, researchers will collect urine samples to study the urinary bacteria. It’s important to note that candidates should not have any urinary infections or other specific health issues, and they should not be on certain medications that could interfere with the study. This trial is a chance to help understand how hormonal changes can affect urinary health in menopausal women.

Gender

FEMALE

Eligibility criteria

• 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