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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Walter Reed National Military Medical Center
Study ID
NCT05221021
Phase
PHASE4
Status
Recruiting
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Conditions

  • Overactive Bladder Syndrome

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Vaginal estrogen — DRUG
    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
  • Mirabegron 50 MG [Myrbetriq] — DRUG
    50mg oral Mirabegron once daily

Study Details

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.

Key Dates

Start date
Oct 1, 2022
Status verified
Aug 2024
Primary completion
Dec 30, 2026
Completion
Jan 30, 2027

Study Design

Enrollment
152 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

OAB-q short form (SF) symptom bother scores [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Walter Reed National Military Medical CenterBethesdaMaryland20889
Deborah Kessler, RN, MSN
[email protected]
301-213-0143

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Walter Reed National Military Medical Center· Bethesda, MD

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