Comparing vaginal estradiol and oral mirabegron for overactive bladder in postmenopausal women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a single-site, double-blinded, randomized controlled trial aimed at evaluating the efficacy of vaginal estradiol cream versus oral mirabegron in treating overactive bladder syndrome in postmenopausal women. Participants will be randomly assigned to receive either 0.01% vaginal estradiol with a placebo oral pill or 50 mg of oral mirabegron with a placebo vaginal cream for a duration of 12 weeks. The study seeks to address the limited data comparing these two treatment options and their impact on symptoms such as urinary urgency and frequency. The trial will assess the effectiveness of these interventions in improving the quality of life for affected women.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Raw score of 14 or more on OAB-q SF (adjusted score of 20)
* Postmenopausal defined by not having a period for 12 months or bilateral oophorectomy a least 12 months status post procedure, or women with prior hysterectomy and preserved ovaries over age 55 years old or having a documented follicle stimulating hormone level greater than 40mIU/mL.
* Ability to speak and read English

Exclusion Criteria:

* Contraindications to Vaginal Estrogen or Mirabegron
* Post void residual \>200mL or \>1/3 patient's total bladder volume
* Currently on or previously taking anticholinergic or beta- 3 agonists within the past 1 month
* Symptomatic pelvic organ prolapse greater than Stage 2, contraindication to vaginal estrogen therapy
* Undiagnosed postmenopausal vaginal bleeding within the past 12 months
* Current diagnosis of Multiple sclerosis, Parkinson's Disease, prior spinal cord injury, Spina Bifida, prior pelvic irradiation, Interstitial Cystitis, recurrent urinary tract infection.

Where it's running

• Walter Reed National Military Medical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Christopher W Heuer, DO — Urogynecology Fellow
• Study coordinator: Christopher W Heuer, DO
• Email: christopher.w.heuer@gmail.com
• Phone: 2626231053

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.