Prophylactic Analgesia for Bladder Botox Injections
NCT Number: NCT06514430
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Urinary Incontinence|Urinary Incontinence, Urge|Overactive Bladder
Interventions: DRUG: Phenazopyridine|DRUG: 1% lidocaine with sodium bicarbonate
Sponsor: Montefiore Medical Center
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-03
Locations: Montefiore Medical Center Female Pelvic Medicine Reconstructive Surgery Department, Bronx, New York, 10467, United States

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.

Primary Outcome Measures: Bladder Pain, Patient-reported bladder pain will be assessed using the Visual Analog Quality of Life Scale (VAS) tool. The VAS is a unidimensional measure of pain intensity. The 100mm VAS intervention tool consists of an emoji face scale ranging from an "open-mouth smile" emoji to a crying emoji. Patients will place an 'x' on the number line below the emojis to indicate where on the scale they would rate their pain, using the emoji faces as a guide. The distance from the lowest (farthest left) point on this scale to the 'x' will be measured and reported in millimeters. Higher scores are associated with increased levels of bladder pain intensity. Group median pain scores will be tabulated and reported., Day of the procedure
Secondary Outcome Measures: Patient satisfaction, Overall patient satisfaction will be measured using a 5-point Likert scale range where 5 = very satisfied; 4 = satisfied; 3= neutral; 2 = unsatisfied; and 1 = very unsatisfied. Overall group mean patient satisfaction scores will be summarized and reported. Higher scores are associated with increased levels of patient satisfaction., 3 days post-procedure|Bladder visualization, Physicians will be queried as to their perception of bladder visualization following the procedure, as oral phenazopyridine is known to temporarily stain the urine orange. Bladder visualization will be performed using cystoscopy to view the inside of the bladder during the procedure. Bladder visualization will be assessed on the following scale: 0 = clear, no difficulty; 1 = somewhat difficult / mildly impaired, 2 = very difficult., Day of the procedure|Bladder Pain, Patient-reported bladder pain will be assessed using the Visual Analog Quality of Life Scale (VAS) tool. The VAS is a unidimensional measure of pain intensity. The 100mm VAS intervention tool consists of an emoji face scale ranging from an "open-mouth smile" emoji to a crying emoji. Patients will place an 'x' on the number line below the emojis to indicate where on the scale they would rate their pain, using the emoji faces as a guide. The distance from the lowest (farthest left) point on this scale to the 'x' will be measured and reported in millimeters. Higher scores are associated with increased levels of bladder pain intensity. Group median pain scores will be tabulated and reported., 3 days post-operation|Postoperative Analgesia, Self-reported use of additional analgesia immediately following the procedure will be evaluated as 0 = no additional analgesia and 1 = any additional analgesia. The number of patients who require any additional postoperative analgesic will be summarized and reported., 3 days post-operation