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

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.

Timeline

Start

2025-06-27

Primary completion

2025-11-10

Completion

2025-11-11

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Indications