Clinical trial NCT03347721: Does Lidocaine Gel Decrease Pain Perception in Women Undergoing Diagnostic Flexible Cystoscopy
Official title: Does Lidocaine Gel Decrease Pain Perception in Women Undergoing Diagnostic Flexible Cystoscopy?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cystoscopy
Lidocaine
Pain Perception
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 129
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain and satisfaction
timeFrame: Recorded immediately after the procedure
Secondary outcomes:
measure: Anticipated pain
timeFrame: Recorded prior to procedure at time of enrollment into study (anticipated) and immediately after procedure
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Louisiana State University- Health Science Center
state: Louisiana
Study officials:
References: