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Compares treatment options for Overactive Bladder Syndrome
Official title Vaginal Estradiol vs Oral Beta-3 Agonist for Overactive Bladder Syndrome
ClinicalTrials.gov ID: NCT05221021
What this study is testing
What is Vaginal estrogen?
Vaginal estrogen is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for overactive bladder syndrome.
Also referred to as Estrace, Estradiol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Ability to speak and read English
You likely can't join if
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.