The Effect of Intraurethral Lidocaine Gel on Pain Perception During Flexible Cystoscopy

March 12, 2019 updated by: Ajet Hyseni

The Effect of Intraurethral Lidocaine Gel in Comparison With Plain Lubricating Gel on Pain Perception During Flexible Cystoscopy: A Prospective Randomized Study

Flexible cystoscopy is routinely performed by urologists. Many patients have concerns to undergo this procedure and expect it to be unpleasant or even painful. Thus, reduction of pain and discomfort during cystoscopy is of great interest, but there is not sufficient evidence regarding the most appropriate conduct of cystoscopy.

In this study the impact of lidocaine gel, patient counseling and monitoring regarding pain perception during flexible cystoscopy are investigated.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lucerne, Switzerland, 6000
        • Recruiting
        • Klinik für Urologie, Kantonsspital Luzern
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men 18 - 80 years
  • Given indication for flexible cystoscopy
  • Written informed consent

Exclusion Criteria:

  • Allergy to amid anesthetics
  • Urinary tract infection
  • Use of analgesics in the previous 24 hours and chronic intake of analgesics
  • Dementia
  • Presence of a sensory disorder such as or spinal cord injury
  • Indwelling catheter carrier

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lidocaine gel, counselling, monitor
Device: Lidocaine gel
10 ml 2% lidocaine gel is instilled with a syringe through the length of the urethra and kept in site at least 5 minutes prior the introduction of the cystoscope.
Other: Counselling
Patients receive a brochure in the waiting room explaining the procedure in details.
Other: Monitor
Patients are allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.
Active Comparator: Lidocaine gel, counselling, no monitor
Device: Lidocaine gel
10 ml 2% lidocaine gel is instilled with a syringe through the length of the urethra and kept in site at least 5 minutes prior the introduction of the cystoscope.
Other: Counselling
Patients receive a brochure in the waiting room explaining the procedure in details.
Other: No monitor
Patients are not allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.
Active Comparator: Lidocaine gel, no counselling, monitor
Device: Lidocaine gel
10 ml 2% lidocaine gel is instilled with a syringe through the length of the urethra and kept in site at least 5 minutes prior the introduction of the cystoscope.
Other: Monitor
Patients are allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.
Other: No counselling
Patients won't receive a brochure in the waiting room explaining the procedure in details.
Active Comparator: Lidocaine gel, no counselling, no monitor
Device: Lidocaine gel
10 ml 2% lidocaine gel is instilled with a syringe through the length of the urethra and kept in site at least 5 minutes prior the introduction of the cystoscope.
Other: No monitor
Patients are not allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.
Other: No counselling
Patients won't receive a brochure in the waiting room explaining the procedure in details.
Placebo Comparator: Lubricating gel, counselling, monitor
Other: Counselling
Patients receive a brochure in the waiting room explaining the procedure in details.
Other: Monitor
Patients are allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.
Device: Lubricating gel
10 ml plain lubrificant gel is instilled with a syringe through the length of the urethra and kept in site at least 5 minutes prior the introduction of the cystoscope.
Placebo Comparator: Lubricating gel, counselling, no monitor
Other: Counselling
Patients receive a brochure in the waiting room explaining the procedure in details.
Other: No monitor
Patients are not allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.
Device: Lubricating gel
10 ml plain lubrificant gel is instilled with a syringe through the length of the urethra and kept in site at least 5 minutes prior the introduction of the cystoscope.
Placebo Comparator: Lubricating gel, no counselling, monitor
Other: Monitor
Patients are allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.
Other: No counselling
Patients won't receive a brochure in the waiting room explaining the procedure in details.
Device: Lubricating gel
10 ml plain lubrificant gel is instilled with a syringe through the length of the urethra and kept in site at least 5 minutes prior the introduction of the cystoscope.
Placebo Comparator: Lubricating gel, no counselling, no monitor
Other: No monitor
Patients are not allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.
Other: No counselling
Patients won't receive a brochure in the waiting room explaining the procedure in details.
Device: Lubricating gel
10 ml plain lubrificant gel is instilled with a syringe through the length of the urethra and kept in site at least 5 minutes prior the introduction of the cystoscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain based on a numeric rating scale
Time Frame: During flexible cystoscopy
The pain scale ranging from 0 ("no pain") to 10 ("worst possible pain").
During flexible cystoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain based on a numeric rating scale
Time Frame: Immediately before flexible cystoscopy
The pain scale ranging from 0 ("no pain") to 10 ("worst possible pain").
Immediately before flexible cystoscopy
Pain based on a numeric rating scale
Time Frame: 10 min after flexible cystoscopy
The pain scale ranging from 0 ("no pain") to 10 ("worst possible pain").
10 min after flexible cystoscopy
Pain based on a numeric rating scale
Time Frame: 3 days after flexible cystoscopy
The pain scale ranging from 0 ("no pain") to 10 ("worst possible pain").
3 days after flexible cystoscopy
Pain based on a verbal rating scale
Time Frame: Immediately after flexible cystoscopy
The pain scale ranging from 0 ("it was not unpleasant") to 5 ("the investigation was almost unbearable").
Immediately after flexible cystoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajet Hyseni

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

March 12, 2019

First Submitted That Met QC Criteria

March 12, 2019

First Posted (Actual)

March 14, 2019

Study Record Updates

Last Update Posted (Actual)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lidocaine-study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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