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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03347721
Other study ID # 9504
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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