Vaginal Estradiol vs Oral Beta-3 Agonist for Overactive Bladder Syndrome
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 pla
| Condition(s) | Overactive Bladder Syndrome |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 t |
| Ages | 18 Years |
| Sex | Female |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Walter Reed National Military Medical Center |
| Locations | Bethesda, Maryland, United States |
| Start date | 2022-10-01 |
| NCT ID | NCT05221021 |
| Official listing | https://clinicaltrials.gov/study/NCT05221021 |