NCT03347721

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
129

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

1.6 years

First QC Date

November 13, 2017

Last Update Submit

March 20, 2018

Conditions

CystoscopyLidocainePain Perception

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Anticipated pain

    Recorded prior to procedure at time of enrollment into study (anticipated) and immediately after procedure

Study Arms (2)

Lidocaine gel

ACTIVE COMPARATOR
Drug: lidocaine gel

Lubricant Gel

PLACEBO COMPARATOR
Drug: Lubricant Gel

Interventions

lidocaine gelDRUG

2% lidocaine jelly, injected into the urethra

Lidocaine gel
Lubricant GelDRUG

Lubricating gel

Also known as: Plain gel
Lubricant Gel

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • need for in office diagnostic flexible cystoscopy

You may not qualify if:

  • urethral stricture
  • simultaneous scheduling or performed additional procedure
  • current urinary tract infection
  • hypersensitivity to local anesthetic of amide type

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louisiana State University- Health Science Center

New Orleans, Louisiana, 70112, United States

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 13, 2017

First Posted

November 20, 2017

Study Start

December 1, 2016

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

March 21, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)