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

NCT05221021 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 21-14282
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• OAB-q short form (SF) symptom bother scores

  Primary Aim: Compare changes in the six-item OAB-q short form (SF) symptom bother scores from baseline to 12 weeks post treatment in postmenopausal women who receive either vaginal estradiol or Mirabegron. We will also compare 12-weeks post treatment OAB-q SF symptom bother scores after single therapy trials with patients who desire combined therapy for another 12 weeks. The OAB-q SF symptom bother questionnaire is based on six individual questions a 6-point scale ranging from 1 or "not at all" to 6 or "a very great deal." Per the guidance of the scoring manual, the raw scores are converted into scores ranging from 0 to 100 (0 being the minimum score and 100 being the maximum score.) The higher the score signifies that the patient has worse bothersome overactive bladder symptoms. The conversion to a 100 point scale is based on the equation as follows: ((Raw score - 6) / 36) x 100.

  12 weeks

Secondary Outcomes (5)

• health-related quality of life (HRQL) of the OAB-q SF scores

  12 weeks

• Patient Global Impression of Severity (PGI-S) scores

  12 weeks

• Patient Global Impression of Improvement (PGI-I) scores

  12 weeks

• Number of voids

  12 weeks

• Number of urge incontinence episodes

  12 weeks

Study Arms (2)

Vaginal Estradiol with placebo oral pill

ACTIVE COMPARATOR

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

Drug: Vaginal estrogen

Oral Mirabegron with placebo vaginal cream

ACTIVE COMPARATOR

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

Drug: Mirabegron 50 MG [Myrbetriq]

Interventions

Vaginal estrogen 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

Also known as: Estrace, Estradiol, Micronized Estrogen

Vaginal Estradiol with placebo oral pill

Mirabegron 50 MG [Myrbetriq] DRUG

50mg oral Mirabegron once daily

Also known as: Myrbetriq

Oral Mirabegron with placebo vaginal cream

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

RECRUITING

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MeSH Terms

Interventions

Estradiol; mirabegron

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Christopher W Heuer, DO

  Urogynecology Fellow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher W Heuer, DO

CONTACT

2626231053; christopher.w.heuer@gmail.com

Katherine L Dengler, MD

CONTACT

3522626861; katidengler12@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single site, double blinded, randomized controlled trial of Mirabegron vs Vaginal Estradiol for overactive bladder syndrome

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: February 2, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)