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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWalter Reed National Military Medical Center

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Vaginal estrogen
  • Mirabegron 50 MG [Myrbetriq]

Treatment groups

152 Participants
are divided into 2 treatment groups