RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Vaginal Estradiol vs Oral Beta-3 Agonist for Treatment of Overactive Bladder Syndrome: A Single-Therapy, Double-Blind, Randomized Controlled Trial

Quick Facts

Study Start:2022-10-01
Study Completion:2027-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05221021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Raw score of 14 or more on OAB-q SF (adjusted score of 20)
  2. * 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.
  3. * Ability to speak and read English
  1. * Contraindications to Vaginal Estrogen or Mirabegron
  2. * Post void residual \>200mL or \>1/3 patient's total bladder volume
  3. * Currently on or previously taking anticholinergic or beta- 3 agonists within the past 1 month
  4. * Symptomatic pelvic organ prolapse greater than Stage 2, contraindication to vaginal estrogen therapy
  5. * Undiagnosed postmenopausal vaginal bleeding within the past 12 months
  6. * Current diagnosis of Multiple sclerosis, Parkinson's Disease, prior spinal cord injury, Spina Bifida, prior pelvic irradiation, Interstitial Cystitis, recurrent urinary tract infection.

Contacts and Locations

Study Contact

Christopher W Heuer, DO
CONTACT
2626231053
christopher.w.heuer@gmail.com
Katherine L Dengler, MD
CONTACT
3522626861
katidengler12@gmail.com

Principal Investigator

Christopher W Heuer, DO
PRINCIPAL_INVESTIGATOR
Urogynecology Fellow

Study Locations (Sites)

Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
United States

Collaborators and Investigators

Sponsor: Walter Reed National Military Medical Center

  • Christopher W Heuer, DO, PRINCIPAL_INVESTIGATOR, Urogynecology Fellow

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-01
Study Completion Date2027-01-30

Study Record Updates

Study Start Date2022-10-01
Study Completion Date2027-01-30

Terms related to this study

Additional Relevant MeSH Terms

  • Overactive Bladder Syndrome