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

RecruitingPhase 4Ages 18 Years - anyFemaleWalter Reed National Military Medical Center
NCT05221021 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Vaginal estrogen
  • Mirabegron 50 MG [Myrbetriq]
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Where

1 site
Walter Reed National Military Medical Center
Bethesda, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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