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

Sponsor

Ajet Hyseni (Other)

Overall Status

Unknown status

CT.gov ID

NCT03874364

Collaborator

(none)

280

Enrollment

Location

Arms

Anticipated Duration (Months)

12.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Flexible Cystoscopy	Device: Lidocaine gel Other: Counselling Other: Monitor Device: Lubricating gel Other: No counselling Other: No monitor	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

280 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2019

Anticipated Primary Completion Date :

Jan 1, 2021

Anticipated Study Completion Date :

Jan 1, 2021

Arms and Interventions

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 counselling Patients won't 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.
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. 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. Other: No monitor Patients are not allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.
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. 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. Other: No counselling Patients won't receive a brochure in the waiting room explaining the procedure in details.
Placebo Comparator: Lubricating gel, no counselling, no monitor	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. Other: No counselling Patients won't 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.

Outcome Measures

Primary Outcome Measures

Pain based on a numeric rating scale [During flexible cystoscopy]
The pain scale ranging from 0 ("no pain") to 10 ("worst possible pain").

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinik für Urologie, Kantonsspital Luzern	Lucerne		Switzerland	6000

Sponsors and Collaborators

Ajet Hyseni

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ajet Hyseni, Dr.med.univ.RKS, Luzerner Kantonsspital

ClinicalTrials.gov Identifier:

NCT03874364

Other Study ID Numbers:

Lidocaine-study

First Posted:

Mar 14, 2019

Last Update Posted:

Mar 14, 2019

Last Verified:

Mar 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Lidocaine

Study Results

No Results Posted as of Mar 14, 2019