Recruiting

Vaginal Estradiol vs. Oral Beta-3 Agonist

Sponsor:

Walter Reed National Military Medical Center

Code:

NCT05221021

Conditions

Overactive Bladder Syndrome

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Vaginal estrogen

Mirabegron 50 MG [Myrbetriq]

Study Details

Brief summary:

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.

Conditions

Overactive Bladder Syndrome

Study ID

NCT05221021

Start date

Oct 1, 2022

Status verified date

Aug, 2024

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

152 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Vaginal estrogen

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]

50mg oral Mirabegron once daily

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Christopher W Heuer, DO

2626231053christopher.w.heuer@gmail.com

Katherine L Dengler, MD

3522626861katidengler12@gmail.com

Locations

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889

Contacts

Deborah Kessler, RN, MSN

301-213-0143deborah.d.kessler.civ@mail.mil

More Information

Sponsor

Walter Reed National Military Medical Center

Last update posted

Aug 19, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed National Military Medical Center on 2024-08-19.