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

Optimal Intravesical Lidocaine Volume for Pain Relief During Office Intra-detrusor Onabotulinum Toxin a Injections: a Prospective Randomized Superiority Trial

The purpose of our study is to evaluate the efficacy and safety of different volumes of bladder-numbing medication for pain relief at the time of office bladder Botox injections. This is a randomized prospective, double-blind superiority trial comparing 200 ml 2% lidocaine versus 30 ml 2% lidocaine for office Botox injections.

Study Overview

• Status: Not yet recruiting
• Conditions: Overactive Bladder; Urge Incontinence; Neurogenic Bladder; Overactive Bladder Syndrome; Urinary Urgency; Urinary Frequency
• Intervention / Treatment: Drug: Lidocaine 2% without vessel constrictor

Detailed Description

The volume of 2% intravesical lidocaine solution and efficacy for pain relief at the time of office intradetrusor Botox A injection has not been well studied. Studies evaluating intravesical lidocaine show that it is not sufficiently absorbed by human bladders to achieve serum toxicity levels and only provides superficial local anesthetic effect. Experts agree that intravesical local anesthetic can be given in the office, with approximately 30 to 40 mL of 2% lidocaine instilled via catheter into the bladder for about 20 minutes before injection. However, there is little evidence regarding this strategy, and future research would help standardize recommendations.

The purpose of our study is to evaluate the efficacy and safety of higher volume pre-procedure intravesical lidocaine solution for pain at the time of intradetrusor office Botox injections. This is a randomized prospective, double-blind superiority trial comparing 200 ml 2% lidocaine versus 30 ml 2% lidocaine for office Botox injections.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sean Francis, MD; Phone Number: 502-588-7660; Email: laurel.carbone@louisvill.edu
• Study Contact Backup: Name: Laurel Carbone, MD

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Division of Urogynecology and Reconstructive Pelvic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Higher volume intravesical lidocaine; 200 ml of 2% lidocaine without epinephrine intravesical instillation 20-30 minutes prior to bladder botox.	Drug: Lidocaine 2% without vessel constrictor; different volumes of intravesical 2% lidocaine without epinephrine, all patients will be receiving bladder botox but this will not be compared; Other Names: onabotulinum toxin
Active Comparator: Lower volume intravesical lidocaine; 30 ml of 2% intravesical lidocaine without epinephrine instilled into the bladder 20-30 minutes prior to bladder botox.	Drug: Lidocaine 2% without vessel constrictor; different volumes of intravesical 2% lidocaine without epinephrine, all patients will be receiving bladder botox but this will not be compared; Other Names: onabotulinum toxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	a. Determine the efficacy of pain relief via the Visual Analog Scale (VAS, scored 0-100 on 100 mm scale with 0 indicating no pain and 100 indicating the worst pain possible) in women randomized to 200 ml 2% lidocaine without epinephrine versus 30 ml 2% lidocaine without epinephrine prior to office intravesical onabotulinum toxin A (Botox) injections i. Perceived maximum VAS during the procedure and post-procedure ii. Superiority limit 20 mm on 100 mm VAS scale	on day of enrollment and procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of Severity (PGI-S)	Likert scale describing current severity of urinary tract condition: 1. Normal, 2. Mild, 3. Moderate, 4. Severe; higher scores indicate worse symptoms	through study completion, an average of 1 year
Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-Sat-q)	An 11-item questionnaire that assesses patient satisfaction with their overactive bladder (OAB) treatment. It includes three sub-scales (satisfaction, side effects, and endorsement) and two single-item assessments (convenience and preference). Scores range from 0-100, higher scores indicate higher satisfaction with treatment. Used to assess treatment satisfaction over time.	This will be assessed pre and post-intervention for all participants through study completion, an average of 1 year
Patient Satisfaction Questionnaire Short-Form (PSQ-18)	An 8-item question assessing satisfaction with medical care experience, measured on a Likert scale with 1 "Strongly agree" and 5 "Strongly disagree", for questions 1-3, 5-6, and 8 lower scores indicate higher satisfaction. For questions 4 and 7 lower scores indicate dissatisfaction.	through study completion, an average of 1 year
Patient Global Impression of Improvement (PGI-I)	7-point Likert scale with 1 indicating "Very much better" and 7 indicating "Very much worse", lower scores indicate more improvement	through study completion, an average of 1 year
Bladder diary	3-day bladder diary with objective patient reported data reporting voids per day, frequency between voids (measured in minutes or hours), episodes of incontinence per day	through study completion, an average of 1 year
Post-void residual volume	Measure voided volume and obtain post-void residual volume either by bladder scan or straight catheterization in the office at 2-week follow up appointment (or additional time points if indicated) following bladder Botox injection	through study completion, an average of 1 year
Adverse events	All adverse events will be recorded and tracked, including urinary tract infection, urinary retention, persistent hematuria, or additional suspected procedural related complications	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University of Louisville
• Investigators: Principal Investigator: Sean Francis, MD, University of Louisville

Publications and helpful links

General Publications

• Nambiar AK, Younis A, Khan ZA, Hildrup I, Emery SJ, Lucas MG. Alkalinized lidocaine versus lidocaine gel as local anesthesia prior to intra-vesical botulinum toxin (BoNTA) injections: A prospective, single center, randomized, double-blind, parallel group trial of efficacy and morbidity. Neurourol Urodyn. 2016 Apr;35(4):522-7. doi: 10.1002/nau.22750. Epub 2015 Mar 8.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Estimated): November 19, 2024

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Bladder Botox; Intravesical lidocaine; office Botox
• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Urinary Incontinence; Urinary Bladder, Overactive; Urinary Bladder, Neurogenic; Urinary Incontinence, Urge; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Lidocaine
• Other Study ID Numbers: 24.0636

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans to share data with other researchers/outside affiliates

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes