Lidocaine for Pain After Urodynamic Testing
Status: | Recruiting |
---|---|
Conditions: | Overactive Bladder, Urology |
Therapuetic Areas: | Gastroenterology, Nephrology / Urology |
Healthy: | No |
Age Range: | 40 - 80 |
Updated: | 4/17/2018 |
Start Date: | January 25, 2018 |
End Date: | December 31, 2018 |
Contact: | Caroline Sabatino, MPH, CCRP |
Email: | caroline.sabatino@atlantichealth.org |
Phone: | 973-971-7361 |
The Impact of Pre-procedure Periurethral Topical Lidocaine Application on Pain Scores After Complex Urodynamic Testing in Women
Urodynamic testing can be associated with mild discomfort, particularly at the time of
insertion, repositioning, and removal of the bladder catheter (a tube inserted into the
bladder via the urethra). Few studies have investigated ways to improve patient comfort
during this procedure. In this study, the investigators want to see if applying external
lidocaine (a numbing gel) prior to the procedure can help to minimize patient discomfort.
insertion, repositioning, and removal of the bladder catheter (a tube inserted into the
bladder via the urethra). Few studies have investigated ways to improve patient comfort
during this procedure. In this study, the investigators want to see if applying external
lidocaine (a numbing gel) prior to the procedure can help to minimize patient discomfort.
Urodynamic testing can be associated with mild discomfort, particularly at the time of
insertion, repositioning, and removal of the bladder catheter (a tube inserted into the
bladder via the urethra). Few studies have investigated ways to improve patient comfort
during this procedure. In this study, the investigators want to see if applying lidocaine (a
numbing gel) prior to the procedure can help to minimize patient discomfort.
Participation in this study will involve only 1 clinic visit (for urodynamic testing), plus 2
phone calls to ask participants about pain (1 at 4-6 hours after testing; and 1 at 24 hours
after testing). Additionally, the investigators will record any adverse effects (such as an
allergic reaction to the gel or new irritation/pain) that happen within 2 weeks after
testing.
Participants will be randomly assigned to receive either lidocaine gel or placebo gel for
their urodynamic testing. The placebo gel will be a standard lubricant gel, meaning that it
contains no active drug. The assigned study regimen will be chosen by chance, like flipping a
coin. Participants will have an equal (50/50) chance of being given either study regimen.
Neither the participant nor the study doctor or nurse practitioner will know which study
regimen the participant is getting. Additionally, a member of the study team will ask
participants about their pain level before and after the testing. The rest of the urodynamic
testing procedure will take place exactly as it would if the participant was not in this
research study.
insertion, repositioning, and removal of the bladder catheter (a tube inserted into the
bladder via the urethra). Few studies have investigated ways to improve patient comfort
during this procedure. In this study, the investigators want to see if applying lidocaine (a
numbing gel) prior to the procedure can help to minimize patient discomfort.
Participation in this study will involve only 1 clinic visit (for urodynamic testing), plus 2
phone calls to ask participants about pain (1 at 4-6 hours after testing; and 1 at 24 hours
after testing). Additionally, the investigators will record any adverse effects (such as an
allergic reaction to the gel or new irritation/pain) that happen within 2 weeks after
testing.
Participants will be randomly assigned to receive either lidocaine gel or placebo gel for
their urodynamic testing. The placebo gel will be a standard lubricant gel, meaning that it
contains no active drug. The assigned study regimen will be chosen by chance, like flipping a
coin. Participants will have an equal (50/50) chance of being given either study regimen.
Neither the participant nor the study doctor or nurse practitioner will know which study
regimen the participant is getting. Additionally, a member of the study team will ask
participants about their pain level before and after the testing. The rest of the urodynamic
testing procedure will take place exactly as it would if the participant was not in this
research study.
Inclusion Criteria:
• All female patients between the ages of 40-80 undergoing urodynamic testing.
Exclusion Criteria:
- Urinary tract infection or symptoms of infection at time of procedure or within past 2
weeks
- History of urinary retention
- Known or suggested history of urethral syndrome or painful bladder syndrome
- Prior anti-incontinence surgery
- Prior pelvic surgery with placement of transvaginal mesh
- Known urethral or bladder anomaly including urethral diverticulum or congenital
anomalies of the bladder or urethra
- History of genital herpes outbreak within the past 3 months
- Defects in mucosal surfaces including periurethral or vaginal abrasions, ulcerations,
or lacerations
- Neurologic disease affecting urethral sensation
- Chronic pelvic pain
- Contraindication or allergy to topical anesthetic
- Pregnancy
- Syncopal episode during preparation for or execution of uroflowometry
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