432 Participants Needed
Women and Infants Hospital of Rhode Island logo

Beta-Agonists vs Botox for Urinary Incontinence

(BEST Trial)

Recruiting in Washington (>99 mi)
+4 other locations
AM
SV
PJ
Overseen ByPeter Jeppson, MD
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: Women and Infants Hospital of Rhode Island
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to compare treatment outcomes between an oral medication (beta agonist) versus onabotulinumtoxinA injections in women with urgency urinary incontinence (UUI).Participants will be randomly selected to receive one of the two treatments. The primary outcome measure will be at 3 months, and women will be followed for a total of 12 months.Based on patient expert input, there are 2 primary outcomes: Treatment satisfaction and urinary symptom severity.

Will I have to stop taking my current medications?

If you are currently taking anticholinergic medications, you will need to stop them for 3 weeks before joining the trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

Is mirabegron safe for treating urinary incontinence?

Mirabegron is generally considered safe for treating urinary incontinence, with most side effects being mild or moderate, such as high blood pressure, dry mouth, constipation, and headache. Studies show no significant increase in adverse events compared to control groups, and it is safe for use in both adults and children with specific dosing guidelines.12345

How does the drug mirabegron differ from other treatments for urinary incontinence?

Mirabegron is unique because it works by stimulating beta-3 adrenergic receptors, which helps relax the bladder muscle, unlike other treatments that often target different pathways. It is available as an extended-release tablet or oral suspension, making it flexible for both adults and children.35678

What data supports the effectiveness of the drug for urinary incontinence?

Research shows that mirabegron, a component of the treatment, is effective in improving symptoms of urinary incontinence in patients with overactive bladder. Studies have demonstrated its efficacy and safety in various populations, including those who have not responded well to other treatments.15678

Who Is on the Research Team?

VS

Vivian Sung, MD, MPH

Principal Investigator

Women and Infants Hospital of Rhode Island

PJ

Peter Jeppson, MD

Principal Investigator

University of New Mexico

Are You a Good Fit for This Trial?

This trial is for women at least 18 years old who are significantly bothered by urgency urinary incontinence, have tried and not benefited from standard treatments, and are not pregnant. They must be willing to stop certain medications before joining the study. Women with mixed symptoms can join if their stress urinary incontinence is less bothersome and stable.

Inclusion Criteria

I am not on anticholinergics or can stop them for 3 weeks before joining.
My main issue is urge incontinence, not stress incontinence, which has been stable for over 3 months and I don't seek treatment for stress incontinence soon.
Are not and do not plan to become pregnant
See 3 more

Exclusion Criteria

I have had pelvic floor surgery in the last 3 months.
I have a condition where my bladder doesn't empty properly.
I cannot take certain medications due to my health condition.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either beta agonist oral medication or intradetrusor onabotulinumtoxinA injections for urgency urinary incontinence

12 months
Visits at 3, 6, 9, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Beta3-Agonists
  • OnabotulinumtoxinA 100 UNT [Botox]
Trial Overview The trial compares two treatments for urgency urinary incontinence: an oral medication called a beta3-agonist (Mirabegron/Vibegron) versus Botox injections. Participants will be randomly assigned to one of these treatments and monitored over 12 months, focusing on treatment satisfaction and symptom severity after 3 months.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Beta-3 receptor agonist oral medicationActive Control1 Intervention
Group II: Intradetrusor onabotulinumtoxinAActive Control1 Intervention

Beta3-Agonists is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Myrbetriq for:
🇪🇺
Approved in European Union as Betmiga for:
🇨🇦
Approved in Canada as Myrbetriq for:
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Approved in Japan as Betanis for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island

Lead Sponsor

Trials
119
Recruited
59,200+

Brown University

Collaborator

Trials
480
Recruited
724,000+

University of New Mexico

Collaborator

Trials
393
Recruited
3,526,000+

University of Alabama at Birmingham

Collaborator

Trials
1,677
Recruited
2,458,000+

University of California, San Diego

Collaborator

Trials
1,215
Recruited
1,593,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Howard University

Collaborator

Trials
44
Recruited
15,200+

Published Research Related to This Trial

In a network meta-analysis of 19 trials involving treatment-experienced patients with overactive bladder, onabotulinumtoxinA showed better outcomes than mirabegron, particularly in reducing the number of urinations and incontinence episodes.
However, mirabegron had a lower risk of urinary tract infections compared to onabotulinumtoxinA, suggesting it may be a safer option for some patients.
The Relative Efficacy and Safety of Mirabegron and OnabotulinumtoxinA in Patients With Overactive Bladder who Have Previously Been Managed With an Antimuscarinic: A Network Meta-analysis.Lozano-Ortega, G., Walker, D., Rogula, B., et al.[2019]
In a study of 35 children with idiopathic overactive bladder who did not respond to antimuscarinics, adding mirabegron significantly improved bladder capacity from 50% to 74% of expected levels, indicating its efficacy as an add-on therapy.
The treatment was generally well tolerated, with only mild to moderate side effects reported in seven patients, and it was deemed a safe alternative for managing urinary incontinence in this pediatric population.
Dual Therapy for Refractory Overactive Bladder in Children: A Prospective Open-Label Study.Morin, F., Blais, AS., Nadeau, G., et al.[2019]
In a 12-week study involving 83 women with urgency urinary incontinence (UUI) treated with mirabegron, those who showed symptom improvement had a significantly richer and more diverse urobiome compared to nonresponders.
The findings suggest that changes in the urobiome may be linked to the effectiveness of mirabegron in treating UUI, indicating a potential mechanism for symptom improvement that requires further investigation.
Symptom improvement with mirabegron treatment is associated with urobiome changes in adult women.Halverson, T., Mueller, ER., Brubaker, L., et al.[2022]

Citations

The Relative Efficacy and Safety of Mirabegron and OnabotulinumtoxinA in Patients With Overactive Bladder who Have Previously Been Managed With an Antimuscarinic: A Network Meta-analysis. [2019]
Dual Therapy for Refractory Overactive Bladder in Children: A Prospective Open-Label Study. [2019]
Symptom improvement with mirabegron treatment is associated with urobiome changes in adult women. [2022]
Phase III, randomised, double-blind, placebo-controlled study of the β3-adrenoceptor agonist mirabegron, 50 mg once daily, in Japanese patients with overactive bladder. [2022]
Real-World Effects of Mirabegron in Patients with Chronic Neurogenic Detrusor Overactivity - A Retrospective Cohort Study. [2022]
Clinical use of the β3 adrenoceptor agonist mirabegron in patients with overactive bladder syndrome. [2020]
Mirabegron: Pediatric First Approval. [2021]
The Efficacy and Safety of Mirabegron for the Treatment of Neurogenic Lower Urinary Tract Dysfunction: A Systematic Review and Meta-analysis. [2021]
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