Lubricant Versus Lidocaine Gel for Pain Control During Urodynamics

NCT ID: NCT01612156

Last Updated: 2015-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-04-30

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.

Conditions

Pelvic Floor Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

2% lidocaine gel

Intervention Type: DRUG

2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination.

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.

Group Type: ACTIVE_COMPARATOR

Water based lubricant

Intervention Type: DRUG

Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination.

Interventions

2% lidocaine gel

2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Lidocaine Hydrochloride Jelly USP, 2%; Surgilube (Savage Laboratories)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Begum Ozel

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vanessa Sun, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

LAC USC Womens clinic

Los Angeles, California, United States

Countries

United States

Other Identifiers

HS- 11- 00573

Identifier Type: -

Identifier Source: org_study_id