Comparing vaginal estradiol and oral mirabegron for overactive bladder in postmenopausal women
Vaginal Estradiol vs Oral Beta-3 Agonist for Treatment of Overactive Bladder Syndrome: A Single-Therapy, Double-Blind, Randomized Controlled Trial
This study is testing whether vaginal estradiol cream or oral mirabegron works better to help postmenopausal women with overactive bladder symptoms.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Walter Reed National Military Medical Center Federal |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05221021 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a single-site, double-blinded, randomized controlled trial aimed at evaluating the efficacy of vaginal estradiol cream versus oral mirabegron in treating overactive bladder syndrome in postmenopausal women. Participants will be randomly assigned to receive either 0.01% vaginal estradiol with a placebo oral pill or 50 mg of oral mirabegron with a placebo vaginal cream for a duration of 12 weeks. The study seeks to address the limited data comparing these two treatment options and their impact on symptoms such as urinary urgency and frequency. The trial will assess the effectiveness of these interventions in improving the quality of life for affected women.
Who should consider this trial
Good fit: Ideal candidates for this study are postmenopausal women experiencing symptoms of overactive bladder, such as urinary frequency and urgency.
Not a fit: Patients with contraindications to vaginal estrogen or mirabegron, or those with certain neurological conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for postmenopausal women suffering from overactive bladder syndrome.
How similar studies have performed: While multiple studies have shown the effectiveness of vaginal estrogen for overactive bladder, this specific comparison with oral mirabegron is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 Cystitis, recurrent urinary tract infection.
Where this trial is running
Bethesda, Maryland
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Christopher W Heuer, DO — Urogynecology Fellow
- Study coordinator: Christopher W Heuer, DO
- Email: christopher.w.heuer@gmail.com
- Phone: 2626231053
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.