RecruitingPhase 4NCT05221021

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

Vaginal Estradiol vs Oral Beta-3 Agonist for Treatment of Overactive Bladder Syndrome: A Single-Therapy, Double-Blind, Randomized Controlled Trial

Sponsor

Walter Reed National Military Medical Center

Enrollment

152 participants

Start Date

Oct 1, 2022

Study Type

INTERVENTIONAL

Conditions

Overactive Bladder Syndrome

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria3

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 Criteria6

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.