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

Lidocaine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03347721
• Other study ID #: 9504
• Status: Active, not recruiting
• Phase: Phase 4
• First received: November 13, 2017
• Last updated: March 20, 2018
• Start date: December 1, 2016
• Est. completion date: June 30, 2018

Study information

• Verified date: March 2018
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 129
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystoscopy
• Lidocaine
• Pain Perception

Intervention

Drug:
• lidocaine gel
2% lidocaine jelly, injected into the urethra
• Lubricant Gel
Lubricating gel

Locations

Country	Name	City	State
United States	Louisiana State University- Health Science Center	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center in New Orleans

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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