Effect of Vaginal Estrogen on Alterations in the Urine Microbiome of Menopausal Women With Overactive Bladder
NCT ID: NCT06780163
Last Updated: 2025-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
30 participants
INTERVENTIONAL
2025-03-01
2025-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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)
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
FEMALE
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Principal Investigators
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Jittima Manonai, MD
Role: STUDY_CHAIR
Ramathibodi Hospital
Locations
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Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, , Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Weber 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.
Krause 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.
Cardozo 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.
Simunic 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.
Gasiorek 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.
Pearce 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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MURA2024/948
Identifier Type: -
Identifier Source: org_study_id
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