Vaginal Estradiol vs Oral Beta-3 Agonist for Overactive Bladder Syndrome
NCT ID: NCT05221021
Last Updated: 2024-08-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE4
Total Enrollment
152 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-10-01
Study Completion Date
2027-01-30
Brief Summary
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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.
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Detailed Description
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Background/significance: Overactive Bladder Syndrome (OAB) is defined as urinary urgency, with or without urgency incontinence, and usually accompanied by frequency and nocturia. OAB remains an increasingly more prevalent disease, affecting over 45% of postmenopausal women over the age 65 within the United States. Epidemiological research continues to consistently highlight OAB's impact on patience's mental health, sleep quality, physical activity, occupational productivity and overall quality of life. OAB's economic burden cannot be overstated as well as a US cost-of-illness study reported a total cost of $66 billion in 2007 and estimated cost of over $82 billion in 2021.
Mainstay first-line forms of management for OAB include behavioral modifications such as bladder training (timed voiding, urge suppression techniques), pelvic floor physical therapy, fluid management and bladder irritant restrictions. Second-line forms of management consistent of pharmacotherapy including oral anticholinergics or beta-3 adrenoreceptor agonists. Multiple studies have shown that vaginal estrogen improves symptoms of urinary urgency and frequency in postmenopausal women. Limited data currently exist comparing beta-3 antagonists to vaginal estrogen use for overactive bladder syndrome as well as the combination of both.
Purpose: This study aims to compare the efficacy of vaginal estradiol with that of oral mirabegron in the treatment of overactive bladder in postmenopausal women and characterize outcomes in women undergoing combined therapy.
Study design: This is a single site, double-blinded, randomized controlled trial for 152 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 1/2 gram once nightly for two weeks then three times per week or 50 milligrams oral Mirabegron once a night.
Procedures: Postmenopausal women with bothersome OAB symptoms will be eligible for the study. OAB symptoms will be based on the OAB-q (SF) symptom bother questionnaire with an initial score greater than 20. Other inclusion criteria include ability to speak English. Exclusion criteria include: Post void residual \>200mL or \>1/3 patient's total bladder volume, currently on or previously taking anticholinergic or beta- 3 antagonists within the past 1 month, untreated, symptomatic pelvic organ prolapse greater than Stage 2, contraindication to vaginal estrogen therapy, contraindication to Mirabegron, undiagnosed postmenopausal vaginal bleeding within the past 12 months, current diagnosis of a condition which explains their overactive bladder or incontinence symptoms.
Participants who elect to enroll will have a post-void residual determined, a demographic sheet, the OAB-q (SF) health-related quality of life (HRQL) questionnaire, a 24-hour voiding diary and Patient Global Impression of Severity (PGI-S). Participants will be randomized via random allocation rule fixed blocking in a 1:1 ratio to either vaginal estrogen or oral Mirabegron. After 12 weeks of single therapy, the patients will be contacted for follow up to complete all previous questionnaires, a 24-hour voiding diary as well as the PGI-I questionnaire. After the initial 12-weeks, single therapy follow up appointment, participants will be offered dual treatment (both vaginal estrogen and Mirabegron same doses/frequencies.) If the patient agrees she will receive dual treatment for 12 weeks and follow up with the same questionnaires.
Mainstay first-line forms of management for OAB include behavioral modifications such as bladder training (timed voiding, urge suppression techniques), pelvic floor physical therapy, fluid management and bladder irritant restrictions. Second-line forms of management consistent of pharmacotherapy including oral anticholinergics or beta-3 adrenoreceptor agonists. Multiple studies have shown that vaginal estrogen improves symptoms of urinary urgency and frequency in postmenopausal women. Limited data currently exist comparing beta-3 antagonists to vaginal estrogen use for overactive bladder syndrome as well as the combination of both.
Purpose: This study aims to compare the efficacy of vaginal estradiol with that of oral mirabegron in the treatment of overactive bladder in postmenopausal women and characterize outcomes in women undergoing combined therapy.
Study design: This is a single site, double-blinded, randomized controlled trial for 152 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 1/2 gram once nightly for two weeks then three times per week or 50 milligrams oral Mirabegron once a night.
Procedures: Postmenopausal women with bothersome OAB symptoms will be eligible for the study. OAB symptoms will be based on the OAB-q (SF) symptom bother questionnaire with an initial score greater than 20. Other inclusion criteria include ability to speak English. Exclusion criteria include: Post void residual \>200mL or \>1/3 patient's total bladder volume, currently on or previously taking anticholinergic or beta- 3 antagonists within the past 1 month, untreated, symptomatic pelvic organ prolapse greater than Stage 2, contraindication to vaginal estrogen therapy, contraindication to Mirabegron, undiagnosed postmenopausal vaginal bleeding within the past 12 months, current diagnosis of a condition which explains their overactive bladder or incontinence symptoms.
Participants who elect to enroll will have a post-void residual determined, a demographic sheet, the OAB-q (SF) health-related quality of life (HRQL) questionnaire, a 24-hour voiding diary and Patient Global Impression of Severity (PGI-S). Participants will be randomized via random allocation rule fixed blocking in a 1:1 ratio to either vaginal estrogen or oral Mirabegron. After 12 weeks of single therapy, the patients will be contacted for follow up to complete all previous questionnaires, a 24-hour voiding diary as well as the PGI-I questionnaire. After the initial 12-weeks, single therapy follow up appointment, participants will be offered dual treatment (both vaginal estrogen and Mirabegron same doses/frequencies.) If the patient agrees she will receive dual treatment for 12 weeks and follow up with the same questionnaires.
Conditions
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Overactive Bladder Syndrome
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Single site, double blinded, randomized controlled trial of Mirabegron vs Vaginal Estradiol for overactive bladder syndrome
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Investigational Pharmacy will randomize all participants via random allocation rule fixed blocking in a 1:1 ratio into either vaginal estrogen treatment group or oral Mirabegron treatment group. Medication doses will be 0.01% estradiol cream 1/2 gram applied vaginally once nightly for two weeks then three times per week or 50 milligrams oral Mirabegron once daily for twelve weeks which are standard doses. The investigators, patients and clinical staff will be blinded to patient allocation. The patients will receive either a placebo vaginal cream or placebo oral medication depending on their treatment allocation. Medications will be dispensed once for their 12 weeks of therapy. The oral placebo and active medication will be encapsulated in gel capsules with filler to give identical weight and appearance. The vaginal cream placebo (Medisca's VersaPro Cream Base) and active medication will be placed in jars and have similar color, smell, and consistency.
Study Groups
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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
Group Type
ACTIVE_COMPARATOR
Vaginal estrogen
Intervention Type
DRUG
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
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
Group Type
ACTIVE_COMPARATOR
Mirabegron 50 MG [Myrbetriq]
Intervention Type
DRUG
50mg oral Mirabegron once daily
Interventions
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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
Intervention Type
DRUG
Mirabegron 50 MG [Myrbetriq]
50mg oral Mirabegron once daily
Intervention Type
DRUG
Other Intervention Names
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Estrace
Estradiol
Micronized Estrogen
Myrbetriq
Eligibility Criteria
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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
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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Walter Reed National Military Medical Center
FED
Sponsor Role
lead
Responsible Party
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Christopher W. Heuer, DO
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Christopher W Heuer, DO
Role: PRINCIPAL_INVESTIGATOR
Urogynecology Fellow
Locations
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Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Coyne K, Revicki D, Hunt T, Corey R, Stewart W, Bentkover J, Kurth H, Abrams P. Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res. 2002 Sep;11(6):563-74. doi: 10.1023/a:1016370925601.
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Wang J, Zhou Z, Cui Y, Li Y, Yuan H, Gao Z, Zhu Z, Wu J. Meta-analysis of the efficacy and safety of mirabegron and solifenacin monotherapy for overactive bladder. Neurourol Urodyn. 2019 Jan;38(1):22-30. doi: 10.1002/nau.23863. Epub 2018 Oct 23.
Reference Type
BACKGROUND
Other Identifiers
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21-14282
Identifier Type: -
Identifier Source: org_study_id
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