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Search / Trial NCT06695585

Optimal Intravesical Lidocaine Volume for Pain Relief During Office Intra-detrusor Onabotulinum Toxin a Injections

Launched by UNIVERSITY OF LOUISVILLE · Nov 15, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Bladder Botox Intravesical Lidocaine Office Botox

ClinConnect Summary

This clinical trial is studying the best way to manage pain during Botox injections for conditions like overactive bladder and urinary incontinence. Specifically, researchers want to find out whether using a larger volume (200 ml) or a smaller volume (30 ml) of a numbing medication called lidocaine is more effective and safe for patients receiving these injections in the office. The study will involve women aged 18 and older who have specific bladder issues that haven't improved with other treatments.

To participate, women must be English-speaking and able to give their consent. They should not have an untreated urinary infection or any reasons that would prevent them from using Botox or lidocaine. During the trial, participants will receive either the larger or smaller volume of lidocaine before their Botox injection, and their pain levels will be monitored. This trial is currently not recruiting participants, but it aims to help improve pain management during this common procedure in the future.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Adult female, \>18 years, English-speaking (surveys utilized are not validated in all languages)
  • Able to provide informed consent
  • Indications: Refractory urge urinary incontinence, Refractory urinary urgency and frequency, Neurogenic bladder (without sensory deficit)
  • Exclusion Criteria:
  • Untreated urinary tract infection at the time of procedure
  • Contra-indication to Botox
  • Contraindication to intravesical lidocaine
  • Inability to provide informed consent
  • Pregnancy, breast-feeding, intending to become pregnant within 6 months of treatment

About University Of Louisville

The University of Louisville is a distinguished academic institution known for its commitment to advancing medical research and clinical innovation. As a clinical trial sponsor, the university leverages its extensive resources and expertise to conduct pioneering studies that aim to improve patient outcomes and enhance healthcare practices. With a focus on interdisciplinary collaboration and community engagement, the University of Louisville fosters an environment conducive to groundbreaking research across various medical fields, ensuring adherence to the highest ethical standards and regulatory compliance. Through its clinical trials, the university seeks to translate scientific discoveries into tangible benefits for patients and the broader community.

Locations

Louisville, Kentucky, United States

Patients applied

0 patients applied

Trial Officials

Sean Francis, MD

Principal Investigator

University of Louisville

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported