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

Flexible Cystoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03874364
• Other study ID #: Lidocaine-study
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: January 2021

Study information

• Verified date: March 2019
• Source: Luzerner Kantonsspital
• Contact: Ajet Hyseni, Dr.med.univ.RKS
• Phone: 0+41 41 205 6959
• Email: ajet.hyseni[@]luks.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Flexible Cystoscopy

Intervention

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.
• 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.
• No monitor
Patients are not allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.

Locations

Country	Name	City	State
Switzerland	Klinik für Urologie, Kantonsspital Luzern	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Ajet Hyseni

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain based on a numeric rating scale	The pain scale ranging from 0 ("no pain") to 10 ("worst possible pain").	During flexible cystoscopy
Secondary	Pain based on a numeric rating scale	The pain scale ranging from 0 ("no pain") to 10 ("worst possible pain").	Immediately before flexible cystoscopy
Secondary	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
Secondary	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
Secondary	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