Vaginal Estradiol vs Oral Beta-3 Agonist for Treatment of Overactive Bladder Syndrome: A Single-Therapy, Double-Blind, Randomized Controlled Trial
Walter Reed National Military Medical Center
Summary
A single site, double-blinded, randomized controlled trial for postmenopausal women with urinary frequency, urgency, nocturia with or without urgency urinary incontinence symptoms. Patient's will be randomized between 0.01% vaginal estradiol cream with placebo oral pill or daily 50 milligrams oral Mirabegron with a placebo vaginal cream for 12 weeks.
Description
Background/significance: Overactive Bladder Syndrome (OAB) is defined as urinary urgency, with or without urgency incontinence, and usually accompanied by frequency and nocturia. OAB remains an increasingly more prevalent disease, affecting over 45% of postmenopausal women over the age 65 within the United States. Epidemiological research continues to consistently highlight OAB's impact on patience's mental health, sleep quality, physical activity, occupational productivity and overall quality of life. OAB's economic burden cannot be overstated as well as a US cost-of-illness study reported a…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- Yes
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 anticholinergi…
Interventions
- DrugVaginal estrogen
0.01% estradiol cream 1/2 gram applied vaginally once nightly for two weeks then three times per week with once daily placebo oral pill
- DrugMirabegron 50 MG [Myrbetriq]
50mg oral Mirabegron once daily
Location
- Walter Reed National Military Medical CenterBethesda, Maryland