Lubricant Versus Lidocaine Gel for Pain Control During Urodynamics

• ClinicalTrials.gov Identifier: NCT01612156
• Recruitment Status: Completed
• First Posted: June 5, 2012
• Results First Posted: January 19, 2015
• Last Update Posted: January 19, 2015
• Sponsor: University of Southern California
• Information provided by (Responsible Party): Begum Ozel, University of Southern California

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.

Condition or disease	Intervention/treatment	Phase
Pelvic Floor Disorders	Drug: 2% lidocaine gel; Drug: Water based lubricant	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Use of 2% Lidocaine Gel Versus Water Based Lubrication: Is There a Difference in Pain During and After Multi-channel Urodynamics?
• Study Start Date: December 2011
• Actual Primary Completion Date: April 2012
• Actual Study Completion Date: April 2012

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 2% lidocaine gel; Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.	Drug: 2% lidocaine gel; 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination.; Other Name: Lidocaine Hydrochloride Jelly USP, 2%
Active Comparator: water based lubricant; 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.	Drug: Water based lubricant; Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination.; Other Name: Surgilube (Savage Laboratories)

Outcome Measures

Primary Outcome Measures :

1. Pain During the Pelvic Floor Examination [ Time Frame: 30 minutes after completion of exam ]

   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 :

1. Embarrassment With Pelvic Floor Examination [ Time Frame: 30 minutes ]
   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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, California

LAC USC Womens clinic

Los Angeles, California, United States, 90033

Sponsors and Collaborators

University of Southern California

Investigators

• Principal Investigator: Vanessa Sun, M.D.; University of Southern California

More Information

• Responsible Party: Begum Ozel, Assistant Professor, University of Southern California
• ClinicalTrials.gov Identifier: NCT01612156
• Other Study ID Numbers: HS- 11- 00573
• First Posted: June 5, 2012
• Results First Posted: January 19, 2015
• Last Update Posted: January 19, 2015
• Last Verified: January 2015

Keywords provided by Begum Ozel, University of Southern California:

Urodynamic testing; pelvic floor examination; Lidocaine gel; Surgical lubricant; Pain; Embarrassment

Additional relevant MeSH terms:

Pelvic Floor Disorders; Pregnancy Complications; 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