Status:
RECRUITING
Vaginal Estradiol vs Oral Beta-3 Agonist for Overactive Bladder Syndrome
Lead Sponsor:
Walter Reed National Military Medical Center
Conditions:
Overactive Bladder Syndrome
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 r...
Detailed Description
Background/significance: Overactive Bladder Syndrome (OAB) is defined as urinary urgency, with or without urgency incontinence, and usually accompanied by frequency and nocturia. OAB remains an increa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2027
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT05221021
Start Date
October 1 2022
End Date
January 30 2027
Last Update
August 19 2024
Active Locations (1)
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1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889