drugset / Trial / NCT06514430

Prophylactic Analgesia for Bladder Botox Injections

NCT06514430

Phase 4 Withdrawn Montefiore Medical Center
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-07
Primary completion
2026-02
Completion
2026-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lidocaine Other / unclassified 1 % Other
Comparator Lidocaine Other / unclassified 50 ml Other
Comparator Phenazopyridine Small molecule 200 mg Oral
Comparator sodium bicarbonate Diagnostic / imaging agent 50 ml Other

Indications