Does Lidocaine Gel Decrease Pain Perception in Women Undergoing Diagnostic Flexible Cystoscopy

Study Overview
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Brief Summary
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This study is to determine if there is a clinically meaningful difference in pain perception for women during in-office diagnostic flexible cystoscopy when using lidocaine gel vs plain lubricant. This will be a double blinded randomized control trial.

Detailed Description
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The use of anesthetic lubricant during in-office flexible cystoscopy has been well studied men. Pain during cystoscopy can lead to poor compliance and follow-up. Very few studies challenging the use of anesthetic lubricant during cystoscopy have included women. Those that have, only recruited a small number with insignificant findings. A meta-analysis reviewed four studies looking at the efficacy of lidocaine gel on pain relief during flexible cystoscopy in men. Four hundred and eleven men underwent flexible cystoscopy with and without the use of lidocaine gel and those who received anesthetic gel were 1.7 times more likely not to experience moderate to severe pain than those who received placebo. The anatomy of the female and male urogenital tract differ. The female urethra is approximately 3cm in length while the male urethra averages 7 cm with an external and prostatic sphincter which is the location where the most discomfort is thought to occur. A randomized control trial of 144 women undergoing rigid cystoscopy and found that pain was decreased with lidocaine vs placebo, however other studies such found no difference in pain perception. The efficacy of lidocaine gel in women during flexible cystoscopy has not been studied. The use of lidocaine gel during diagnostic flexible cystoscopy in women is based on surgeon preference and experience, and use of either plain or anesthetic gel, is currently acceptable clinical practice. The morbidity and cost of local anesthesia associated with cystoscopy in women is unknown due to the lack of studies. The objective of this study is to determine if there is a clinically meaningful difference in pain perception in women during in-office diagnostic flexible cystoscopy when using lidocaine gel vs plain lubricant.

Official Title
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Does Lidocaine Gel Decrease Pain Perception in Women Undergoing Diagnostic Flexible Cystoscopy?

Conditions
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Cystoscopy, Lidocaine, Pain Perception

Intervention / Treatment
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* Drug: lidocaine gel
* Drug: Lubricant Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: need for in office diagnostic flexible cystoscopy Exclusion Criteria: urethral stricture simultaneous scheduling or performed additional procedure current urinary tract infection hypersensitivity to local anesthetic of amide type

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine gel<br> | Drug: lidocaine gel<br>* 2% lidocaine jelly, injected into the urethra<br>|
| Placebo Comparator: Lubricant Gel<br> | Drug: Lubricant Gel<br>* Lubricating gel<br>* Other names: Plain gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and satisfaction | Composite of pain and satisfaction as determined by a Numeric Rating Scale for pain (validated measure) rating pain, as well as answers to yes or no questions asking if patient would repeat procedure in same method and if pain medicine is needed at end of procedure. | Recorded immediately after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anticipated pain | Composite of pain anticipated during procedure and compared to actual pain perceived as determined by a Numeric Rating Scale for pain (validated measure) rating pain | Recorded prior to procedure at time of enrollment into study (anticipated) and immediately after procedure |