Vaginal Estradiol vs Oral Beta-3 Agonist for Overactive Bladder Syndrome
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Overactive Bladder Syndrome
In brief
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.
Key facts
- Study ID
- NCT05221021
- Run by
- Walter Reed National Military Medical Center
- People needed
- 152
- Starts
- 2022-10-01
- Expected to finish
- 2027-01-30
- Last updated by the study team
- 2024-08-19
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.