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Neurotoxin
Botox Injections for Overactive Bladder
Phase 4
Recruiting
Led By Carly Crowder, MD
Research Sponsored by University of California, Irvine
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 1 day
Treatment 1 days
Follow Up 3 months
Awards & highlights
Study Summary
This trial will test whether injecting Botox® into the bladder at one site or ten sites is more effective at treating overactive bladder or urgency urinary incontinence. Efficacy and patient satisfaction will be measured by questionnaires.
Who is the study for?
This trial is for women over 18 with an overactive bladder or urgency urinary incontinence. Participants must not be on certain bladder treatments, pregnant, or have conditions like a neurogenic bladder. They should not have had Botox injections for the condition in the last six months and must speak English or Spanish.Check my eligibility
What is being tested?
The study tests if fewer injection sites of Botox (one versus ten) are as effective for treating symptoms of an overactive bladder. Women will be randomly assigned to one of the two groups and their satisfaction and symptom relief will be tracked via questionnaires.See study design
What are the potential side effects?
Possible side effects include pain at the injection site, urinary tract infections, difficulty urinating, and allergic reactions to Botox such as swelling or redness.
Timeline
Screening ~ 1 day1 visit
Treatment ~ 1 days1 visit
Follow Up ~ 3 months2 visits
Screening ~ 1 day
Treatment ~ 1 days
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Urinary Bladder
Number of participants with urinary tract infection (UTI)
Patient Global Impression - Improvement (PGI-I)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 1 Injection SiteExperimental Treatment1 Intervention
100u Botox® injected at one intradetrusor site
Group II: 10 Injection SitesActive Control1 Intervention
100u Botox® injected at 10 intradetrusor sites
Find a Location
Who is running the clinical trial?
Kaiser PermanenteOTHER
538 Previous Clinical Trials
24,113,686 Total Patients Enrolled
St. Joseph Hospital of OrangeOTHER
9 Previous Clinical Trials
864,981 Total Patients Enrolled
University of California, IrvineLead Sponsor
543 Previous Clinical Trials
1,922,899 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with a condition called neurogenic bladder.You have been diagnosed with overactive bladder or urinary urgency incontinence.You are a woman.You must stop taking medication for overactive bladder at least two weeks before the injection and avoid taking them during the three-month follow-up after the procedure.You cannot speak English or Spanish.You have received botox injections inside your bladder in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: 1 Injection Site
- Group 2: 10 Injection Sites
Awards:
This trial has 3 awards, including:- 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.
- 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 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 1 Days
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Months after you stop receiving the treatment.
Urge Urinary Incontinence Patient Testimony for trial: Trial Name: NCT05308979 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers currently recruiting participants for this study?
"The data on clinicaltrials.gov indicates that this experiment is still actively seeking applicants. It was initially advertised on May 1st 2022 and the last time it was updated was 16th of May 2022."
Answered by AI
Does the FDA endorse OnabotulinumtoxinA 100 UNT [Botox] as a viable therapeutic?
"Botox has been approved and is thusly rated 3 on the safety scale. As this trial falls under Phase 4, we can be assured of its efficacy."
Answered by AI
How many individuals are actively participating in this clinical experiment?
"Affirmatively, clinicaltrials.gov displays that this medical trial is actively searching for enrollees. The study was initiated on May 1st 2022 and most recently updated on the 16th of May; 102 patients need to be recruited from 2 different sites."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
University of California Irvine Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
0
Why did patients apply to this trial?
Nothing else has worked . Have enlarged prostate take medicine.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- University of California Irvine Medical Center: < 24 hours
Average response time
- < 2 Days
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