Prophylactic Analgesia for Bladder Botox Injections

NCT06514430 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2024-16001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Incontinence; Urinary Incontinence, Urge; Overactive Bladder

Keywords

onabotulinumtoxinA (Botox) injection; oral phenazopyridine; intravesical lidocaine; Urban Patient Population; Analgesia; Pain Management; Diverse Populations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patient satisfaction

  3 days post-procedure

• Bladder visualization

  Day of the procedure

• Bladder Pain

  3 days post-operation

• Postoperative Analgesia

  3 days post-operation

Study Arms (2)

Oral phenazopyridine

ACTIVE COMPARATOR

Patients randomized to the oral phenzopyridine arm will receive 200 milligrams (mg) phenazopyridine orally prior to the scheduled procedure.

Drug: Phenazopyridine

Intravesical lidocaine

ACTIVE COMPARATOR

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.

Drug: 1% lidocaine with sodium bicarbonate

Interventions

Phenazopyridine DRUG

200mg PO Phenazopyridine taken prior to the Botox® injection procedure as an analgesic.

Also known as: Pyridium

Oral phenazopyridine

1% lidocaine with sodium bicarbonate DRUG

50cc of 1% lidocaine with 50cc sodium bicarbonate injected into the bladder lumen prior to the Botox® injection procedure.

Also known as: Intravesical lidocaine

Intravesical lidocaine

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women
• years or older
• Planning to undergo surgical management of idiopathic overactive bladder with intradetrusor onabotulinumtoxinA injection at Montefiore Medical Center Female Pelvic Medicine Reconstructive Surgery Department
• Provided informed consent

You may not qualify if:

• Currently pregnant
• Current Urinary Tract Infection (UTI)
• Neurogenic bladder diagnosis
• Received pelvic radiotherapy
• Severe cognitive impairment
• Non-English or non-Spanish speaking.

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center Female Pelvic Medicine Reconstructive Surgery Department

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Urge; Urinary Bladder, Overactive; Agnosia

Interventions

Phenazopyridine; Lidocaine; Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Aminopyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Melissa Laudano, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: July 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)