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Beta-3 Agonist
Vaginal Estrogen vs Oral Mirabegron for Overactive Bladder
Phase 4
Recruiting
Led By Christopher W Heuer, DO
Research Sponsored by Walter Reed National Military Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial is testing whether estradiol cream or Mirabegron pills can relieve urinary frequency, urgency, and nocturia symptoms in postmenopausal women.
Who is the study for?
This trial is for postmenopausal women with overactive bladder symptoms who can read and speak English. They must have had no periods for 12 months, or certain surgeries, or high hormone levels. Women with significant pelvic issues, neurological conditions like MS or Parkinson's, a history of pelvic radiation, interstitial cystitis, frequent UTIs, or recent use of similar meds cannot join.Check my eligibility
What is being tested?
The study compares vaginal estradiol cream against an oral beta-3 agonist called Mirabegron for treating overactive bladder in postmenopausal women. Participants will be randomly assigned to receive either the estradiol cream with a placebo pill or Mirabegron pills with a placebo cream for 12 weeks.See study design
What are the potential side effects?
Possible side effects include local reactions to vaginal estrogen such as irritation and discharge; systemic hormonal effects are less common but may occur. Mirabegron could cause increased blood pressure, headaches, urinary tract infections (UTI), and heart palpitations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
OAB-q short form (SF) symptom bother scores
Secondary outcome measures
Number of urge incontinence episodes
Number of voids
Patient Global Impression of Improvement (PGI-I) scores
+2 moreTrial Design
2Treatment groups
Active Control
Group I: Vaginal Estradiol with placebo oral pillActive Control1 Intervention
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
Group II: Oral Mirabegron with placebo vaginal creamActive Control1 Intervention
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
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Who is running the clinical trial?
Walter Reed National Military Medical CenterLead Sponsor
137 Previous Clinical Trials
34,345 Total Patients Enrolled
Christopher W Heuer, DOPrincipal InvestigatorUrogynecology Fellow
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe pelvic organ prolapse and cannot use vaginal estrogen therapy.You have a medical reason that prevents you from using vaginal estrogen or mirabegron.You have had unexplained vaginal bleeding after menopause in the last year.You have a large amount of urine left in your bladder after you pee.Your score on the OAB-q SF questionnaire is 14 or higher (which is adjusted to 20).You have been diagnosed with multiple sclerosis, Parkinson's disease, spinal cord injury, spina bifida, pelvic irradiation, interstitial cystitis, or recurrent urinary tract infections.You are currently using or have used certain types of medications for bladder control within the past month.You are a woman who has stopped having periods for at least a year, had both ovaries removed at least a year ago, had a hysterectomy and still have ovaries and are over 55 years old, or have a specific hormone level.
Research Study Groups:
This trial has the following groups:- Group 1: Vaginal Estradiol with placebo oral pill
- Group 2: Oral Mirabegron with placebo vaginal cream
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential hazards could a patient incur by undergoing this treatment?
"Due to this medical intervention being approved with Phase 4 trials, its safety has been rated as a 3 on the scale of 1-3."
Answered by AI
How many volunteers are enrolled in this clinical experiment?
"Affirmative. The information found on clinicaltrials.gov verifies that this medical trial is currently enrolling participants, with 152 patients required from one specialized centre. It was initially posted in October 1st 2022 and the most recent update was registered November 3rd 2022."
Answered by AI
Are researchers presently enrolling participants in this experiment?
"Affirmative. Clinicaltrials.gov attests to this experiment's progress, which has been operational since October 1st 2022 and last edited on November 3rd 2022; 152 participants from one medical centre are needed for enrollment."
Answered by AI
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