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Analgesic

Intravesical lidocaine for Overactive Bladder

Phase 4
Waitlist Available
Led By Melissa Laudano, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Women
* 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days post-operation
Awards & highlights

Summary

The goal of this clinical trial is to learn more about using phenazopyridine (Pyridium) for pain control during bladder onabotulinumtoxinA ("botox") injections for surgical management of overactive bladder (OAB) for patients at Montefiore Medical Center in The Bronx. It will also learn about if using the phenazopyridine pill affects how satisfied patients are with their experience, how much pain patients feel afterwards, and if doctors think using the Pyridium pill affected how they performed the procedure. The main question it aims to answer is: - Is oral phenazopyridine at least as good as intravesical lidocaine is for managing pain with bladder botox injections for OAB in Montefiore patients? Researchers will compare phenazopyridine to intravesical lidocaine, a liquid put into the bladder, to see if phenazopyridine is at least as good at controlling pain with bladder botox injections as intravesical lidocaine is. Participants will be assigned, by chance, to receive either the oral phenazopyridine pill or the intravesical lidocaine as their pain control for the procedure.

Who is the study for?
This trial is for patients at Montefiore Medical Center with overactive bladder conditions who are undergoing botox injections for treatment. Participants should not have any health issues that would interfere with the study or medication use.
What is being tested?
The study compares oral phenazopyridine (Pyridium) to intravesical lidocaine, which is a liquid administered into the bladder, to see if Pyridium can manage pain as effectively during bladder botox injections.
What are the potential side effects?
Possible side effects of phenazopyridine may include headache, dizziness, stomach cramps and orange-colored urine. Lidocaine might cause symptoms like local irritation and in rare cases systemic toxicity.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 days post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Bladder Pain
Bladder visualization
Patient satisfaction
+1 more

Trial Design

2Treatment groups
Active Control
Group I: Intravesical lidocaineActive Control1 Intervention
Patients randomized to the intravesical lidocaine arm will be administered 50 cubic centimeters (cc) of 1% lidocaine with 50cc sodium bicarbonate within the bladder immediately prior to the procedure.
Group II: Oral phenazopyridineActive Control1 Intervention
Patients randomized to the oral phenzopyridine arm will receive 200 milligrams (mg) phenazopyridine orally prior to the scheduled procedure.

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
455 Previous Clinical Trials
583,295 Total Patients Enrolled
Melissa Laudano, MDPrincipal InvestigatorMontefiore Medical Center
~80 spots leftby Mar 2025