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

Study Overview
=================
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.

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

Conditions
-----------------
Flexible Cystoscopy

Intervention / Treatment
-----------------
* Device: Lidocaine gel
* Other: Counselling
* Other: Monitor
* Device: Lubricating gel
* Other: No counselling
* Other: No monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine gel, counselling, monitor<br> | Device: Lidocaine gel<br>* 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.<br>Other: Counselling<br>* Patients receive a brochure in the waiting room explaining the procedure in details.<br>Other: Monitor<br>* Patients are allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.<br>|
| Active Comparator: Lidocaine gel, counselling, no monitor<br> | Device: Lidocaine gel<br>* 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.<br>Other: Counselling<br>* Patients receive a brochure in the waiting room explaining the procedure in details.<br>Other: No monitor<br>* Patients are not allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.<br>|
| Active Comparator: Lidocaine gel, no counselling, monitor<br> | Device: Lidocaine gel<br>* 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.<br>Other: Monitor<br>* Patients are allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.<br>Other: No counselling<br>* Patients won't receive a brochure in the waiting room explaining the procedure in details.<br>|
| Active Comparator: Lidocaine gel, no counselling, no monitor<br> | Device: Lidocaine gel<br>* 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.<br>Other: No counselling<br>* Patients won't receive a brochure in the waiting room explaining the procedure in details.<br>Other: No monitor<br>* Patients are not allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.<br>|
| Placebo Comparator: Lubricating gel, counselling, monitor<br> | Other: Counselling<br>* Patients receive a brochure in the waiting room explaining the procedure in details.<br>Other: Monitor<br>* Patients are allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.<br>Device: Lubricating gel<br>* 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.<br>|
| Placebo Comparator: Lubricating gel, counselling, no monitor<br> | Other: Counselling<br>* Patients receive a brochure in the waiting room explaining the procedure in details.<br>Device: Lubricating gel<br>* 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.<br>Other: No monitor<br>* Patients are not allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.<br>|
| Placebo Comparator: Lubricating gel, no counselling, monitor<br> | Other: Monitor<br>* Patients are allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.<br>Device: Lubricating gel<br>* 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.<br>Other: No counselling<br>* Patients won't receive a brochure in the waiting room explaining the procedure in details.<br>|
| Placebo Comparator: Lubricating gel, no counselling, no monitor<br> | Device: Lubricating gel<br>* 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.<br>Other: No counselling<br>* Patients won't receive a brochure in the waiting room explaining the procedure in details.<br>Other: No monitor<br>* Patients are not allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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