Actively Recruiting
Vaginal Estradiol vs Oral Beta-3 Agonist for Overactive Bladder Syndrome
Led by Walter Reed National Military Medical Center · Updated on 2024-08-19
152
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Vaginal Estradiol vs Oral Beta-3 Agonist for Overactive Bladder Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Raw score of 14 or more on OAB-q SF (adjusted score of 20)
- Postmenopausal defined by no menstrual period for 12 months or bilateral oophorectomy at least 12 months ago, or women with prior hysterectomy and preserved ovaries over age 55, or documented follicle stimulating hormone level greater than 40mIU/mL
- Ability to speak and read English
You will not qualify if you...
- Contraindications to vaginal estrogen or Mirabegron
- Post void residual greater than 200mL or more than one-third of the patient's total bladder volume
- Current or recent use (within past month) of anticholinergic or beta-3 agonist medications
- Symptomatic pelvic organ prolapse greater than Stage 2
- 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, or recurrent urinary tract infection
AI-Screening
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Trial Site Locations
Total: 1 location
1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Actively Recruiting
Research Team
C
Christopher W Heuer, DO
CONTACT
K
Katherine L Dengler, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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