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Local Anesthetic
Lidocaine for Overactive Bladder
Phase 4
Waitlist Available
Led By Sean Francis, MD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Contra-indication to Botox
Untreated urinary tract infection at the time of procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial is comparing two different amounts of numbing medication given before Botox injections in the bladder to see which one works better and is safer.
Who is the study for?
This trial is for individuals with various bladder conditions like overactive bladder and neurogenic bladder. Participants should be scheduled for office Botox injections to manage their condition but cannot join if they have specific health issues that the study doesn't list.
What is being tested?
The study is testing two different volumes of a numbing medication called lidocaine given during Botox injections in the bladder. It's a controlled test where patients are randomly assigned to receive either 200 ml or 30 ml of lidocaine, without knowing which one they get.
What are the potential side effects?
Lidocaine may cause side effects such as temporary burning or stinging sensations at the injection site, dizziness, nausea, or rarely more serious reactions like irregular heartbeats.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot use Botox due to health reasons.
Select...
I do not have a current urinary tract infection.
Select...
I cannot use lidocaine inside my bladder due to health reasons.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Visual Analog Scale (VAS)
Secondary study objectives
Adverse events
Bladder diary
Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-Sat-q)
+4 moreAwards & 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: Higher volume intravesical lidocaineActive Control1 Intervention
200 ml of 2% lidocaine without epinephrine intravesical instillation 20-30 minutes prior to bladder botox.
Group II: Lower volume intravesical lidocaineActive Control1 Intervention
30 ml of 2% intravesical lidocaine without epinephrine instilled into the bladder 20-30 minutes prior to bladder botox.
Find a Location
Who is running the clinical trial?
University of LouisvilleLead Sponsor
348 Previous Clinical Trials
77,665 Total Patients Enrolled
Sean Francis, MDPrincipal InvestigatorUniversity of Louisville
1 Previous Clinical Trials
100 Total Patients Enrolled