Home › NCT05221021
Vaginal Estradiol vs Oral Beta-3 Agonist for Overactive Bladder Syndrome
Vaginal Estradiol vs Oral Beta-3 Agonist for Treatment of Overactive Bladder Syndrome: A Single-Therapy, Double-Blind, Randomized Controlled Trial
Who can join
Ages 18 and older · Women · Healthy volunteers welcome
Full eligibility criteria
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.
About the study
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.
What is being tested
- Vaginal estrogen (drug)
- Mirabegron 50 MG [Myrbetriq] (drug)
Sponsor: Walter Reed National Military Medical Center · Participants: 152 · Started: Oct 1, 2022
Contact the study team
- Christopher W Heuer, DO · Phone: 2626231053
- Katherine L Dengler, MD · Phone: 3522626861
Official record on ClinicalTrials.gov — NCT05221021
Locations in the U.S.
| Maryland | Walter Reed National Military Medical Center, Bethesda |
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.