Lubricant Versus Lidocaine Gel for Pain Control During Urodynamics

Pelvic Floor Disorders Clinical Trial

Official title:

Use of 2% Lidocaine Gel Versus Water Based Lubrication: Is There a Difference in Pain During and After Multi-channel Urodynamics?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612156
• Other study ID #: HS- 11- 00573
• Status: Completed
• Phase: N/A
• First received: May 31, 2012
• Last updated: January 16, 2015
• Start date: December 2011
• Est. completion date: April 2012

Study information

• Verified date: January 2015
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Floor Disorders

Intervention

Drug:
• 2% lidocaine gel
2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination.
• Water based lubricant
Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination.

Locations

Country	Name	City	State
United States	LAC USC Womens clinic	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	30 minutes after completion of exam	No
Secondary	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.	30 minutes	No