Does Lidocaine Gel Decrease Pain Perception in Women Undergoing Diagnostic

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03347721
Study type	Interventional
Source	Louisiana State University Health Sciences Center in New Orleans
Contact
Status	Active, not recruiting
Phase	Phase 4
Start date	December 1, 2016
Completion date	June 30, 2018

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms