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Effects of Topical Lidocaine During Urodynamic Testing In Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03881293
Recruitment Status : Completed
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Collaborators:
Medical College of Wisconsin
WomenConnected
Information provided by (Responsible Party):
Kristine Zinkgraf, ProHealth Care, Inc

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Urinary Stress Incontinence Pain Drug: lidocaine 2% gel Drug: water soluble lubricant Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double Blinded Randomized Control Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Topical Lidocaine During Urodynamic Testing In Women
Actual Study Start Date : December 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in pain immediately after urethral pressure profilometry [ Time Frame: Pain was assessed immediately after urethral pressure profilometry was performed ]
    Patient rated pain using Likert Scale of 0-10 (0 is no pain and 10 is worst pain)


Secondary Outcome Measures :
  1. Demonstration of stress urinary incontinence during the urodynamic test [ Time Frame: During the urodynamic test ]
    Ability to demonstrate stress urinary incontinence during the urodynamic test

  2. Perception of bladder filling [ Time Frame: During the urodynamic test ]
    Correlation of maximal cystometric capacity on urodynamic test and maximal voided volume on bladder diary



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881293


Sponsors and Collaborators
Kristine Zinkgraf
Medical College of Wisconsin
WomenConnected
Investigators
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Principal Investigator: Katherine Stevenson, MD ProHealth Care
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Responsible Party: Kristine Zinkgraf, Advanced Practice Nurse, ProHealth Care, Inc
ClinicalTrials.gov Identifier: NCT03881293    
Other Study ID Numbers: IRB#12-09
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristine Zinkgraf, ProHealth Care, Inc:
urodynamics
women
lidocaine gel
Additional relevant MeSH terms:
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Urinary Incontinence, Stress
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action