Vaginal Estradiol vs Oral Beta-3 Agonist for Treatment of Overactive Bladder Syndrome: A Single-Therapy, Double-Blind, Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
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• 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
Locations
United States
Maryland
Walter Reed National Military Medical Center
RECRUITING
Bethesda
Contact Information
Primary
Christopher W Heuer, DO
christopher.w.heuer@gmail.com
2626231053
Backup
Katherine L Dengler, MD
katidengler12@gmail.com
3522626861
Time Frame
Start Date: 2022-10-01
Estimated Completion Date: 2027-01-30
Participants
Target number of participants: 152
Treatments
Active_comparator: Vaginal Estradiol with placebo oral pill
Patient will receive 0.01% estradiol cream 1/2 gram applied vaginally once nightly for two weeks then three times per week with once daily placebo oral pill
Active_comparator: Oral Mirabegron with placebo vaginal cream
Patient will receive 50 milligrams oral Mirabegron once daily and placebo vaginal cream (Medisca's VersaPro Cream Base) once nightly for two weeks then three times per week
Related Therapeutic Areas
Sponsors
Leads: Walter Reed National Military Medical Center