Does Lidocaine Gel Decrease Pain Perception in Women Unde... | NCT03347721

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

NCT03347721

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Status

Unknown status

Last Update Posted

Mar 21, 2018Actual

Enrollment

129Actual

Phase

Phase 4

Conditions

Cystoscopy
Lidocaine
Pain Perception

Interventions

lidocaine gel
Lubricant Gel

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2016Actual

Primary Completion Date

Jun 30, 2018Estimated

Completion Date

Jun 30, 2018Estimated

First Submitted Date

Nov 13, 2017

First Submission Date that Met QC Criteria

Nov 15, 2017

First Posted Date

Nov 20, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2018

Last Update Posted Date

Mar 21, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Erin Dougher, Principal Investigator, Louisiana State University Health Sciences Center in New OrleansPrincipal Investigator

Lead Sponsor

Louisiana State University Health Sciences Center in New OrleansOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

129Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lidocaine gel	Active Comparator		Drug: lidocaine gel
Lubricant Gel	Placebo Comparator		Drug: Lubricant Gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lidocaine gel	Drug	2% lidocaine jelly, injected into the urethra	Lidocaine gel

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Louisiana State University- Health Science Center		New Orleans	Louisiana	70112	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided