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

NCT06780163 | Completed Phase 4

• 1 other identifier: MURA2024/948
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Microbiome; Overactive Bladder (OAB); Menopause

Outcome Measures

Primary Outcomes (1)

• Change in Lactobacillus abundance

  Change in Lactobacillus abundance (measure by urine microbiome study) after vaginal estrogen therapy

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (2)

• Change in urine microbiome diversity

  From enrollment to the end of treatment at 12 weeks

• Association of change in urine microbiome with overactive bladder symptoms

  From enrollment to the end of treatment at 12 weeks

Study Arms (1)

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)

Drug: 17β-estradiol 10 mcg

Interventions

17β-estradiol 10 mcg DRUG

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

Also known as: Femiest®

Estrogen

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Bangkok, 10400, Thailand

Location

Related Publications (7)

• 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.

  PMID: 19937315 BACKGROUND

• 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.

  PMID: 26383760 BACKGROUND

• 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.

  PMID: 22229022 BACKGROUND

• 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.

  PMID: 12521832 BACKGROUND

• 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.

  PMID: 12873780 BACKGROUND

• 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.

  PMID: 31619534 BACKGROUND

• 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.

  PMID: 25006228 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Jittima Manonai, MD

  Ramathibodi Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: June 27, 2025
• Primary Completion: November 10, 2025
• Study Completion: November 11, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• Access Criteria: Only research collaborators will have access to the data.

Locations

TH (1)