Lubricant Versus Lidocaine Gel for Pain Control During Urodynamics
Primary Purpose
Pelvic Floor Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
2% lidocaine gel
Water based lubricant
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Floor Disorders focused on measuring Urodynamic testing, pelvic floor examination, Lidocaine gel, Surgical lubricant, Pain, Embarrassment
Eligibility Criteria
Inclusion Criteria:
- Women 18 years of age or older
- Scheduled to undergo multichannel urodynamic study
- Able to give informed consent
- Able to read and write in English or Spanish
Exclusion Criteria:
- Any contraindication to multichannel urodynamic study
- Allergy to water based lubricant or lidocaine
- Any active pelvic or lower urinary tract infection
Sites / Locations
- LAC USC Womens clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
2% lidocaine gel
water based lubricant
Arm Description
Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.
Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.
Outcomes
Primary Outcome Measures
Pain During the Pelvic Floor Examination
Subjects will be asked to report their pain level using the Wong Baker pain scale at the beginning of the exam, after a cotton tipped swab test, after the urodynamic catheters are placed in the urethra, and then 30 minutes after the completion of the exam.
The Wong Baker pain scale ranges from 0 (no pain) to 10 (worst pain possible).
Secondary Outcome Measures
Embarrassment With Pelvic Floor Examination
The participants will be asked to report their level of embarrasment during the exam using a Likert scale from 1 (no embarrassment) to 5 (most embarrasment possible) at 30 minutes after completion of the exam.
Full Information
NCT ID
NCT01612156
First Posted
May 31, 2012
Last Updated
January 16, 2015
Sponsor
University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT01612156
Brief Title
Lubricant Versus Lidocaine Gel for Pain Control During Urodynamics
Official Title
Use of 2% Lidocaine Gel Versus Water Based Lubrication: Is There a Difference in Pain During and After Multi-channel Urodynamics?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine a difference in patient reported pain levels before, during, and after multichannel urodynamics in patients treated with 2% lidocaine gel or water based lubricant. We hypothesize that lidocaine gel will decrease pain levels when compared to lubricant gel.
Detailed Description
The evaluation of the incontinent patient usually includes in and out catheterization for post void residual urinary volume, a cotton tipped swab test, and urodynamic testing. All of these evaluations require manipulation of the urethra by either a catheter or a cotton tipped swab. To minimize discomfort, water based lubricant or 2% lidocaine gel is often used to ease passage of the device into the urethra. In 2008, Harmanli et al. performed a randomized control trial showing use of 2% lidocaine gel significantly decreased pain during the cotton tipped swab test and in and out catheterization. However, data looking at cystourethroscopy in women suggests that 2% lidocaine gel does little to relieve discomfort over lubricant alone. There are no studies looking at whether 2% lidocaine gel decreases the pain associated with multichannel urodynamic testing when compared to using lubricant alone. The purpose of this study is to determine a difference in patient reported pain levels before, during, and after multichannel urodynamics in patients treated with 2% lidocaine gel or water based lubricant. We hypothesize that lidocaine gel will decrease pain levels when compared to lubricant gel.
This study design is a prospective double blinded randomized controlled trial.
Participants will be randomized to the 2% lidocaine gel or the lubricant gel group after informed consent is obtained and immediately before undergoing multichannel urodynamics. Sequentially numbered sealed opaque envelopes containing the identity of the study arm will be used for randomization. The urogynecology clinic nurse will prepare the selected gel (either the 2% lidocaine gel or the water based lubricant) on the procedure field without any identification. Since the gels look identical, both the examiner and the patient will be blinded to their assigned arm. The participant will undergo the standard clinic exam in standardized order, which consists of perineal/vulvar sensation exam, measurement of post void residual, cotton tipped swab test, pelvic organ prolapse quantification measurements, pelvic exam with speculum, bi-manual exam, and multichannel urodynamic testing. The study gel will be applied to the red robinson catheter for in and out catheterization, the cotton tipped swab, and the bladder catheter for multichannel urodynamic study. The participant will be asked for their pain level at specific points (before the start of the exam, after placement of the bladder catheter, immediately after completion of the study, 30 minutes after completion of the study) using the Wong-Baker pain scale. At the conclusion of the procedure, the participant will be given a short survey to complete about their expectations of the procedure and their pain level. The practitioner/investigator will also be given a short survey to complete at the end of the examination to assess their idea of the patient's comfort level during the procedure. Data will be entered into a database for analysis using the independent samples t test, the Mann-Whitney U test, and the chi square test.
We will specifically be using Lidocaine Hydrochloride Jelly USP, 2% and Surgilube (Savage Laboratories). Surgilube is a water based lubricating gel used during gynecologic exams. It is available in 5g individually wrapped sterile packets. Lidocaine gel is also readily available for use in the gynecologic clinics, available in 5ml individually wrapped sterile packets. Both are clear, viscous, odorless, gels that are visually identical. Currently both are used in the standard urogynecologic exam, depending on operator preference.
All patients scheduled for urodynamic testing will be invited to participate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders
Keywords
Urodynamic testing, pelvic floor examination, Lidocaine gel, Surgical lubricant, Pain, Embarrassment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2% lidocaine gel
Arm Type
Active Comparator
Arm Description
Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.
Arm Title
water based lubricant
Arm Type
Active Comparator
Arm Description
Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.
Intervention Type
Drug
Intervention Name(s)
2% lidocaine gel
Other Intervention Name(s)
Lidocaine Hydrochloride Jelly USP, 2%
Intervention Description
2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination.
Intervention Type
Drug
Intervention Name(s)
Water based lubricant
Other Intervention Name(s)
Surgilube (Savage Laboratories)
Intervention Description
Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination.
Primary Outcome Measure Information:
Title
Pain During the Pelvic Floor Examination
Description
Subjects will be asked to report their pain level using the Wong Baker pain scale at the beginning of the exam, after a cotton tipped swab test, after the urodynamic catheters are placed in the urethra, and then 30 minutes after the completion of the exam.
The Wong Baker pain scale ranges from 0 (no pain) to 10 (worst pain possible).
Time Frame
30 minutes after completion of exam
Secondary Outcome Measure Information:
Title
Embarrassment With Pelvic Floor Examination
Description
The participants will be asked to report their level of embarrasment during the exam using a Likert scale from 1 (no embarrassment) to 5 (most embarrasment possible) at 30 minutes after completion of the exam.
Time Frame
30 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women 18 years of age or older
Scheduled to undergo multichannel urodynamic study
Able to give informed consent
Able to read and write in English or Spanish
Exclusion Criteria:
Any contraindication to multichannel urodynamic study
Allergy to water based lubricant or lidocaine
Any active pelvic or lower urinary tract infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa Sun, M.D.
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
LAC USC Womens clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
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Lubricant Versus Lidocaine Gel for Pain Control During Urodynamics
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