Overactive Bladder (OAB)Phase 4NCT06780163
Effect of Vaginal Estrogen on Alterations in the Urine Microbiome of Menopausal Women With Overactive Bladder
A Phase 4 study testing 17β-estradiol 10 mcg in people with Overactive Bladder (OAB) and Menopause, run by Mahidol University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Overactive Bladder (OAB), Menopause, Microbiome
- What is being tested?
- 17β-estradiol 10 mcg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 27 Jun 2025to 11 Nov 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, 10400
About this study
Official title: 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:
Read more
To evaluate the effects of vaginal estrogen on the level of Lactobacillus in the urine of postmenopausal women with OAB.
Secondary Objectives
- To evaluate the effects of vaginal estrogen on urine microbiome in postmenopausal women with OAB.
- 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.
Read the 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:
- Measuring changes in Lactobacillus abundance in urine after vaginal estrogen therapy. (Primary objective)
- Measuring changes in the overall urinary microbiome diversity. (Secondary objective)
- 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.
- Conditions
- Overactive Bladder (OAB), Menopause, Microbiome
- Being tested
- 17β-estradiol 10 mcg
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17β-estradiol 10 mcgDrug
Also called Femiest®
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
| Study group | Role | What they receive |
|---|---|---|
| Estrogen | Experimental | 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) Receives: Drug: 17β-estradiol 10 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lactobacillus abundance
Change in Lactobacillus abundance (measure by urine microbiome study) after vaginal estrogen therapy
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (2)
Change in urine microbiome diversity
Change in urine microbiome diversity after vaginal estrogen therapy (measured by urine microbiome study)
Measured: From enrollment to the end of treatment at 12 weeks
Association of change in urine microbiome with overactive bladder symptoms
Association of change in urine microbiome with overactive bladder symptoms measured by questionnaire (OAB-q SF)
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start27 Jun 2025
- Primary completion10 Nov 2025
- Study completion11 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jittima Manonai, MD, Study chair, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780163
- Sponsor's protocol ID
- MURA2024/948
- Status last verified
- Feb 2026
- First submitted
- 13 Jan 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.
PubMed 19937315Weber MA, Kleijn MH, Langendam M, Limpens J, Heineman MJ, Roovers JP. Local Oestrogen for Pelvic Floor Disorders: A Systematic Review. PLoS One. 2015 Sep 18;10(9):e0136265. doi: 10.1371/journal.pone.0136265. eCollection 2015.
PubMed 26383760Krause M, Wheeler TL 2nd, Snyder TE, Richter HE. Local Effects of Vaginally Administered Estrogen Therapy: A Review. J Pelvic Med Surg. 2009 May;15(3):105-114. doi: 10.1097/SPV.0b013e3181ab4804.
PubMed 22229022Cardozo LD, Wise BG, Benness CJ. Vaginal oestradiol for the treatment of lower urinary tract symptoms in postmenopausal women--a double-blind placebo-controlled study. J Obstet Gynaecol. 2001 Jul;21(4):383-5. doi: 10.1080/01443610120059941.
PubMed 12521832Simunic V, Banovic I, Ciglar S, Jeren L, Pavicic Baldani D, Sprem M. Local estrogen treatment in patients with urogenital symptoms. Int J Gynaecol Obstet. 2003 Aug;82(2):187-97. doi: 10.1016/s0020-7292(03)00200-5.
PubMed 12873780Gasiorek M, Hsieh MH, Forster CS. Utility of DNA Next-Generation Sequencing and Expanded Quantitative Urine Culture in Diagnosis and Management of Chronic or Persistent Lower Urinary Tract Symptoms. J Clin Microbiol. 2019 Dec 23;58(1):e00204-19. doi: 10.1128/JCM.00204-19. Print 2019 Dec 23.
PubMed 31619534Pearce MM, Hilt EE, Rosenfeld AB, Zilliox MJ, Thomas-White K, Fok C, Kliethermes S, Schreckenberger PC, Brubaker L, Gai X, Wolfe AJ. The female urinary microbiome: a comparison of women with and without urgency urinary incontinence. mBio. 2014 Jul 8;5(4):e01283-14. doi: 10.1128/mBio.01283-14.
PubMed 25006228
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-Post Quasi-Experimental Study to Evaluate the Effects of Vaginal Estrogen on the Urine Microbiome and Overactive Bladder Symptoms in Menopausal Women
- ClinicalTrials.gov ID
- NCT06780163
- Acronym / sponsor ID
- MURA2024/948
- Conditions
- Overactive Bladder (OAB), Menopause, Microbiome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To evaluate the effects of vaginal estrogen on urine microbiome in postmenopausal women with OAB.
- 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.
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:
- Measuring changes in Lactobacillus abundance in urine after vaginal estrogen therapy. (Primary objective)
- Measuring changes in the overall urinary microbiome diversity. (Secondary objective)
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Estrogen | Experimental | Drug: 17β-estradiol 10 mcgParticipants 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) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 17β-estradiol 10 mcgAlso: Femiest®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 | Drug | Estrogen |
Primary outcome
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
2 secondary outcomes
Change in urine microbiome diversity
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Background: PubMed 19937315Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.
- Background: PubMed 26383760Weber MA, Kleijn MH, Langendam M, Limpens J, Heineman MJ, Roovers JP. Local Oestrogen for Pelvic Floor Disorders: A Systematic Review. PLoS One. 2015 Sep 18;10(9):e0136265. doi: 10.1371/journal.pone.0136265. eCollection 2015.
- Background: PubMed 22229022Krause M, Wheeler TL 2nd, Snyder TE, Richter HE. Local Effects of Vaginally Administered Estrogen Therapy: A Review. J Pelvic Med Surg. 2009 May;15(3):105-114. doi: 10.1097/SPV.0b013e3181ab4804.
- Background: PubMed 12521832Cardozo LD, Wise BG, Benness CJ. Vaginal oestradiol for the treatment of lower urinary tract symptoms in postmenopausal women--a double-blind placebo-controlled study. J Obstet Gynaecol. 2001 Jul;21(4):383-5. doi: 10.1080/01443610120059941.
- Background: PubMed 12873780Simunic V, Banovic I, Ciglar S, Jeren L, Pavicic Baldani D, Sprem M. Local estrogen treatment in patients with urogenital symptoms. Int J Gynaecol Obstet. 2003 Aug;82(2):187-97. doi: 10.1016/s0020-7292(03)00200-5.
- Background: PubMed 31619534Gasiorek M, Hsieh MH, Forster CS. Utility of DNA Next-Generation Sequencing and Expanded Quantitative Urine Culture in Diagnosis and Management of Chronic or Persistent Lower Urinary Tract Symptoms. J Clin Microbiol. 2019 Dec 23;58(1):e00204-19. doi: 10.1128/JCM.00204-19. Print 2019 Dec 23.
- Background: PubMed 25006228Pearce MM, Hilt EE, Rosenfeld AB, Zilliox MJ, Thomas-White K, Fok C, Kliethermes S, Schreckenberger PC, Brubaker L, Gai X, Wolfe AJ. The female urinary microbiome: a comparison of women with and without urgency urinary incontinence. mBio. 2014 Jul 8;5(4):e01283-14. doi: 10.1128/mBio.01283-14.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jittima Manonai, MD study chair
Ramathibodi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 17β-estradiol 10 mcg in people with Overactive Bladder (OAB) and Menopause, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lactobacillus abundance (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06780163, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.