Effects of Topical Lidocaine During Urodynamic Testing In Women

Urodynamic testing is used to help diagnose causes of urinary incontinence and voiding dysfunction. The purpose of the urodynamic test is to gain insight into the patient's urinary symptoms and assist in making a diagnosis. Catheter insertion and manipulation during the test can be uncomfortable for the patient. Lidocaine gel has not been used routinely during urodynamic testing. However, it is used routinely during outpatient cystoscopy and with any urethral catheterization. The investigators proposed that lidocaine numbing gel could be used without compromising test findings.

The study included 110 adult women. The purpose was:

1. Determine whether the use of topical lidocaine during urodynamic testing decreases patient discomfort during the procedure.
2. Evaluate whether the use of topical lidocaine affects the urodynamic results.

Study Overview

• Status: Completed
• Conditions: Pain; Urinary Stress Incontinence
• Intervention / Treatment: Drug: water soluble lubricant; Drug: lidocaine 2% gel

Detailed Description

Topical Lidocaine For Urodynamic Testing: A Double Blinded Randomized Control Trial

Hypothesis / aims of study

1. Determine whether the use of topical lidocaine during urodynamic testing decreases patient discomfort during the procedure.
2. Evaluate whether the use of topical lidocaine affects the urodynamic results.

Study design, materials and methods The hospital IRB approved the study. Women with symptoms of stress urinary incontinence (SUI) scheduled for a urodynamic study (UDS) were eligible to participate. Women presenting with predominant overactive bladder symptoms were excluded. Participants were randomized on the day of the procedure using Random Allocation Software Version 1.0. All were blinded to the study arms until completion of final data analysis. Participant randomization assignment was known only to an independent research nurse and the dispensing pharmacist. The study consisted of transurethral administration of 5 ml lidocaine 2% gel or surgilube gel, in the study and control arms, respectively, 10 minutes before catheter insertion. Prior to testing, a 24 hour bladder diary and the Pelvic Floor Distress Inventory - Short Form 20 were completed. During the UDS participants were asked for sensory information including desire to void and maximal cystometric capacity (MCC). Urethral pressure profiles were obtained at an infused volume of 200 ml. Provocative measures were performed to assess SUI. Using a Likert scale, pain was assessed prior to and after catheter insertion, after performing the urethral pressure profile, and at the completion of the study. The primary outcome; pain after urethral pressure profile (UPP), was compared between the two groups. Comparisons of the bladder diary and UDS results were made between study and control arms individually and in-between groups.

Statistical methods The effect of lidocaine on patient pain as reported during multiple time-points during the UDS was evaluated using repeated measures analysis via mixed effects regression with a random patient-specific intercept. This approach allows the evaluation of the overall pain experience, as well as baseline-adjusted comparison at individual time-points. Comparisons were done using t-tests for continuous variables, Chi-squared test for categorical variables, Wilcoxon rank-sum test, Lin's Concordance Correlation Coefficient (CCC), and a z-test. The CCC provides a generalization of Pearson's correlation coefficient that measures how well the data align with the diagonal representing equal values for the two measurements (as opposed to any straight line). Agreement is stronger than correlation. Specifically, the agreement between mean void volume and volume at strong desire, as well as between maximum void volume and volume at MCC were computed separately for each study group. The CCC values were compared between the study groups using a z-test. Power calculations determined a total sample size of 110 participants was needed to detect significant differences between the groups with at least 94% statistical power.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

Women with complaint of stress urinary incontinence who were scheduled for a urodynamic test Patients with symptomatic pelvic organ prolapse if they also had stress incontinence symptoms.

Community dwelling elderly patients who were able to provide their own history and were able to sign for themselves

Exclusion Criteria:

Patients who were unable to provide their own consent Patients who are allergic to lidocaine Children and pregnant patients

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
Placebo Comparator: Placebo Lubricant Gel; 5 ml water-soluble gel instilled transurethrally ten minutes prior to catheter insertion	Drug: water soluble lubricant; Transurethral instillation of 5 ml water soluble lubricant
Active Comparator: Lidocaine 2% Gel; 5 ml lidocaine 2% gel instilled transurethrally ten minutes prior to catheter insertion	Drug: lidocaine 2% gel; Transurethral instillation of 5 ml lidocaine 2% gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain immediately after urethral pressure profilometry	Patient rated pain using Likert Scale of 0-10 (0 is no pain and 10 is worst pain)	Pain was assessed immediately after urethral pressure profilometry was performed

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demonstration of stress urinary incontinence during the urodynamic test	Ability to demonstrate stress urinary incontinence during the urodynamic test	During the urodynamic test
Perception of bladder filling	Correlation of maximal cystometric capacity on urodynamic test and maximal voided volume on bladder diary	During the urodynamic test

Collaborators and Investigators

• Sponsor: Kristine Zinkgraf
• Collaborators: Medical College of Wisconsin; WomenConnected
• Investigators: Principal Investigator: Katherine Stevenson, MD, Prohealth Care

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: March 15, 2019
• First Posted (Actual): March 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 15, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: women; urodynamics; lidocaine gel
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Stress; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: IRB#12-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No