Vaginal Estradiol vs Oral Beta-3 Agonist for Overactive Bladder Syndrome
Recruiting
Phase 4Interventional Study
Overactive Bladder Syndrome
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
152 (estimated)
Sponsor
Walter Reed National Military Medical Center · Federal
Who this trial is looking for
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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.
Trial Locations
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Status
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 …
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.
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