What side effects are associated with this type of intervention?

Vaginal estradiol, used to improve vaginal tissue health, may cause local irritation, discharge, and a potential increased risk of endometrial hyperplasia if used without progesterone in women with an intact uterus. Oral mirabegron, which relaxes the bladder muscle, can cause side effects such as hypertension, nasopharyngitis, urinary tract infection, headache, and gastrointestinal issues like constipation. These side effects should be considered when selecting a treatment for Overactive Bladder.

What prior FDA approvals exist?

The FDA has approved several treatments for Overactive Bladder (OAB). Mirabegron, a beta3-adrenoceptor agonist, is one such drug that relaxes the bladder muscle to reduce symptoms of OAB. It is available in 25 or 50 mg doses and has been shown to be effective in managing OAB symptoms. Additionally, anticholinergic agents like tolterodine and solifenacin have been approved, which work by blocking the action of acetylcholine on the bladder muscle. While vaginal estradiol is primarily used to improve vaginal tissue health, it is being studied for its potential benefits in treating OAB symptoms in postmenopausal women.

What other types of research exist?

Promising novel alternatives for Overactive Bladder treatment in 2024 include: 1) Beta-3 adrenergic agonists like vibegron, which relax the bladder muscle similar to mirabegron but may offer improved efficacy and safety profiles. 2) Neuromodulation therapies such as percutaneous tibial nerve stimulation (PTNS) and sacral neuromodulation (SNM), which modulate nerve activity to reduce OAB symptoms. 3) Anticholinergic medications with improved side effect profiles, such as fesoterodine. 4) Emerging therapies like botulinum toxin injections into the bladder muscle, which can reduce muscle overactivity and improve symptoms.

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Beta-3 Agonist

Vaginal Estrogen vs Oral Mirabegron for Overactive Bladder

Phase 4

Recruiting

Led By Christopher W Heuer, DO

Research Sponsored by Walter Reed National Military Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial tests a vaginal estrogen cream and an oral pill called Mirabegron in postmenopausal women with overactive bladder symptoms. The cream helps improve bladder function by adding estrogen, while the pill relaxes the bladder to reduce frequent urination.

Who is the study for?

This trial is for postmenopausal women with overactive bladder symptoms who can read and speak English. They must have had no periods for 12 months, or certain surgeries, or high hormone levels. Women with significant pelvic issues, neurological conditions like MS or Parkinson's, a history of pelvic radiation, interstitial cystitis, frequent UTIs, or recent use of similar meds cannot join.

What is being tested?

The study compares vaginal estradiol cream against an oral beta-3 agonist called Mirabegron for treating overactive bladder in postmenopausal women. Participants will be randomly assigned to receive either the estradiol cream with a placebo pill or Mirabegron pills with a placebo cream for 12 weeks.

What are the potential side effects?

Possible side effects include local reactions to vaginal estrogen such as irritation and discharge; systemic hormonal effects are less common but may occur. Mirabegron could cause increased blood pressure, headaches, urinary tract infections (UTI), and heart palpitations.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

OAB-q short form (SF) symptom bother scores

Secondary study objectives

Number of urge incontinence episodes

Number of voids

Patient Global Impression of Improvement (PGI-I) scores

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Active Control

Group I: Vaginal Estradiol with placebo oral pillActive Control1 Intervention

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 II: Oral Mirabegron with placebo vaginal creamActive Control1 Intervention

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Vaginal Estradiol works by improving the health of vaginal tissues, which can enhance the structural support of the bladder and urethra, potentially reducing symptoms of urgency and frequency in postmenopausal women. Oral Mirabegron, a beta3-adrenoceptor agonist, relaxes the bladder muscle (detrusor muscle) during the storage phase of the bladder fill-void cycle, increasing bladder capacity and reducing the sensation of urgency. These mechanisms are crucial for OAB patients as they directly address the underlying issues of bladder muscle overactivity and weakened pelvic support, thereby improving quality of life by reducing the frequency and urgency of urination.