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Search / Trial NCT06514430

Prophylactic Analgesia for Bladder Botox Injections

Launched by MONTEFIORE MEDICAL CENTER · Jul 17, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Onabotulinumtoxin A (Botox) Injection Oral Phenazopyridine Intravesical Lidocaine Urban Patient Population Analgesia Pain Management Diverse Populations

ClinConnect Summary

This clinical trial, taking place at Montefiore Medical Center, is studying how well a medication called phenazopyridine (Pyridium) can help manage pain during bladder Botox injections for women with overactive bladder (OAB). The main goal is to find out if taking this pill for pain control is just as effective as using a liquid pain relief method called intravesical lidocaine, which is directly put into the bladder. Researchers will also look at how satisfied patients feel about their experience and how much pain they have after the procedure.

To be eligible for this study, participants must be women aged 18 or older who are planning to receive Botox injections for OAB at Montefiore. However, women who are currently pregnant, have a urinary tract infection, or have certain other medical conditions will not be able to participate. If you join the study, you will be randomly assigned to receive either the oral phenazopyridine pill or the intravesical lidocaine for pain control during your Botox injection. The trial is not yet recruiting participants, but it aims to offer valuable insights into pain management options for women undergoing this procedure.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Women
  • 18 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
  • Exclusion Criteria:
  • Currently pregnant
  • Current Urinary Tract Infection (UTI)
  • Neurogenic bladder diagnosis
  • Received pelvic radiotherapy
  • Severe cognitive impairment
  • Non-English or non-Spanish speaking.

About Montefiore Medical Center

Montefiore Medical Center is a leading academic medical institution located in the Bronx, New York, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a principal sponsor of clinical studies, Montefiore fosters a collaborative environment that connects researchers, healthcare professionals, and patients to explore cutting-edge therapies and improve health outcomes. With a strong emphasis on patient-centered care, the center integrates its extensive clinical expertise with robust research capabilities to address a wide range of medical conditions, contributing significantly to the advancement of medical science and clinical practice.

Locations

Bronx, New York, United States

Patients applied

0 patients applied

Trial Officials

Melissa Laudano, MD

Principal Investigator

Montefiore Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported