Vaginal Estradiol vs Oral Beta-3 Agonist for Overactive Bladder Syndrome

• Status: Not yet recruiting
• Trial end date: 2024-01-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Walter Reed National Military Medical Center
• Treatments: Estradiol; Estrogens; Mirabegron

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 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.