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

Description

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.

Conditions

Overactive Bladder Syndrome

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Overactive Bladder Syndrome
Intervention / Treatment

-

Contacts and Locations

Bethesda

Walter Reed National Military Medical Center, Bethesda, Maryland, United States, 20889

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Walter Reed National Military Medical Center,

Christopher W Heuer, DO, PRINCIPAL_INVESTIGATOR, Urogynecology Fellow

Study Record Dates

2027-01-30