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RecruitingAccepts healthy volunteersPhase 4

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

Walter Reed National Military Medical Center · NCT05221021

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
152
US sites recruiting
1
Study start
October 1, 2022
Record last updated
August 19, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Vaginal estrogen; Mirabegron 50 MG [Myrbetriq]

Conditions: Overactive Bladder Syndrome

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Walter Reed National Military Medical Center

    Bethesda, MD 20889

    Site contact: Deborah Kessler, RN, MSN · 301-213-0143 · deborah.d.kessler.civ@mail.mil

Study contacts (from the official record)

  • Christopher W Heuer, DO · 2626231053 · christopher.w.heuer@gmail.com
  • Katherine L Dengler, MD · 3522626861 · katidengler12@gmail.com
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