Clinical Trial: Lubricant Versus Lidocaine Gel for Pain Control During Urodynamics
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Use of 2% Lidocaine Gel Versus Water Based Lubrication: Is There a Difference in Pain During and After Multi-channel Urodynamics?
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 Summary:
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. T
Sponsor: University of Southern California
Current Primary Outcome: 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).
Original Primary Outcome: Pain During the Pelvic Floor Examination [ Time Frame: 30 minutes after completion of exam ]
Current Secondary Outcome: Embarrassment With Pelvic Floor Examination [ Time Frame: 30 minutes ]
Original Secondary Outcome: Embarrassment With Pelvic Floor Examination [ Time Frame: 30 minutes ]
Information By: University of Southern California
Dates:
Date Received: May 31, 2012
Date Started: December 2011
Date Completion:
Last Updated: January 16, 2015
Last Verified: January 2015
