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

Launched by WALTER REED NATIONAL MILITARY MEDICAL CENTER · Jan 31, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for women who have Overactive Bladder Syndrome, which causes frequent and urgent need to urinate, especially at night. The trial will compare a vaginal cream containing estrogen to an oral medication called Mirabegron, which is taken as a pill. Participants will either receive the estrogen cream with a placebo (a pill that has no active ingredients) or the Mirabegron pill with a placebo cream. This study will last for 12 weeks and aims to find out which treatment is more effective in helping with urinary symptoms.

To be eligible for this trial, participants must be postmenopausal women, meaning they have not had a period for at least a year, or have undergone certain surgeries that affect their hormone levels. They should also be able to read and speak English. However, women with certain medical conditions or those taking specific medications that could interfere with the study will not be eligible. If you join this trial, you can expect to attend regular visits over the 12 weeks, where your urinary symptoms will be monitored to see how well the treatments are working.

Gender

FEMALE

Eligibility 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.