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Adrenergic

Beta-Agonists vs Botox for Urinary Incontinence (BEST Trial)

Phase 4

Recruiting

Led By Vivian Sung, MD, MPH

Research Sponsored by Women and Infants Hospital of Rhode Island

Eligibility Criteria Checklist

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

Must have

Age 18 years or older

Be older than 18 years old

Must not have

Pelvic floor surgery within the past 3 months

Neurogenic bladder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, 9, 12 months

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial will compare two treatments for women with UUI: an oral medication or injections. Patients will be followed for 12 months to measure satisfaction & symptom severity.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Beta3-agonists may cause high blood pressure, headache, or cold-like symptoms. Botox could lead to urinary tract infections, difficulty urinating requiring temporary catheterization, or rarely generalized muscle weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had pelvic floor surgery in the last 3 months.

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I have a condition where my bladder doesn't empty properly.

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I cannot take certain medications due to my health condition.

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I expect to have pelvic surgery within the next 3 months.

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I have had radiation therapy to my pelvic area before.

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I have blood in my urine or a history of bladder cancer.

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I have had surgery on the muscle that controls my bladder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, 9, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, 9, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 9, 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in score Overactive Bladder Questionnaire-Symptom Bother Scale (OAB-q-SS) at 3 months

Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General Questionnaire (FACIT-TS-G) at 3 months

Secondary study objectives

Change in Overactive Bladder Questionnaire-Health Related Quality of Life (OAB-q-HRQL)

Change in Overactive Bladder Questionnaire-Symptom Bother Scale (OAB-q-SS)

Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR)

+1 more

Other study objectives

PROMIS Cognitive Function-Short Form

Awards & Highlights

Drug Has Already Been Approved

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

Pivotal Trial

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

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: Beta-3 receptor agonist oral medicationActive Control1 Intervention

Selective beta-3 receptor agonist oral medication approved for the treatment of urgency urinary incontinence including mirabegron or vibegron. Usual clinical care standards will be used for prescribing and dosing changes. For mirabegron, dosages are 25 mg and 50 mg as clinically indicated. For vibegron, dosage is 75 mg daily by mouth as clinically indicated.

Group II: Intradetrusor onabotulinumtoxinAActive Control1 Intervention

OnabotulinumtoxinA at a dose of 100 units will be injected into the bladder per usual care pathways.

0 / 8Eligibility criteria met