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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 9, 12 months
Awards & highlights
BEST Trial 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.Check my eligibility
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.See study design
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.
BEST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
BEST Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in score Overactive Bladder Questionnaire-Symptom Bother Scale (OAB-q-SS) at 3 months
Secondary outcome measures
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)
+2 moreOther outcome measures
PROMIS Cognitive Function-Short Form
BEST 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.
Find a Location
Who is running the clinical trial?
Brown UniversityOTHER
456 Previous Clinical Trials
557,912 Total Patients Enrolled
1 Trials studying Urinary Incontinence
386 Patients Enrolled for Urinary Incontinence
University of New MexicoOTHER
372 Previous Clinical Trials
3,528,357 Total Patients Enrolled
12 Trials studying Urinary Incontinence
2,074 Patients Enrolled for Urinary Incontinence
University of Alabama at BirminghamOTHER
1,590 Previous Clinical Trials
2,281,030 Total Patients Enrolled
15 Trials studying Urinary Incontinence
6,729 Patients Enrolled for Urinary Incontinence
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have had pelvic floor surgery in the last 3 months.I am quite bothered by sudden urges to urinate leading to urine loss.I have ongoing urinary incontinence despite trying basic treatments or can't take certain medications due to side effects or other reasons.I have a condition where my bladder doesn't empty properly.I cannot take certain medications due to my health condition.I expect to have pelvic surgery within the next 3 months.I am 18 years old or older.I tried a neuromodulation treatment that didn't work and waited 4 weeks.I have had radiation therapy to my pelvic area before.I have blood in my urine or a history of bladder cancer.You had a significant amount of urine left in your bladder after going to the bathroom in the past 3 months.I have had surgery on the muscle that controls my bladder.
Research Study Groups:
This trial has the following groups:- Group 1: Beta-3 receptor agonist oral medication
- Group 2: Intradetrusor onabotulinumtoxinA
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA granted its stamp of approval for Beta-3 receptor agonist oral medication?
"This Beta-3 receptor agonist oral medication has been approved, so it is given a score of 3 for its safety."
Answered by AI
How many sites are actively managing this research project?
"The research is recruiting patients at the University of California, San Diego (San Diego, CA), Howard University (Washington D.C.) and the University of New mexico (Albuquerque, NM) in addition to 5 more sites."
Answered by AI
Is enrollment in this research endeavor currently available to participants?
"Clinicaltrials.gov's records indicate that this experiment is not currently accepting patients, as the most recent update was on March 28th of 2023. Although no longer recruiting for participants, there are still 150 other trials searching for volunteers at this time."
Answered by AI
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