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

Not Applicable

• Conditions: Flexible Cystoscopy
• Interventions: Device: Lidocaine gel; Other: No counselling; Other: Counselling; Other: Monitor; Device: Lubricating gel; Other: No monitor

• Registration Number: NCT03874364
• Lead Sponsor: Ajet Hyseni

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Status Verified: 2019-03
• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-03-12
• Last Update Submitted: 2019-03-12
• Study First Posted: 2019-03-14
• Last Update Posted: 2019-03-14
• Primary Completion: 2021-01
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 280

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine gel, no counselling, no monitor	No counselling	-
Lidocaine gel, counselling, monitor	Lidocaine gel	-
Lidocaine gel, counselling, monitor	Counselling	-
Lidocaine gel, counselling, monitor	Monitor	-
Lidocaine gel, counselling, no monitor	Counselling	-
Lidocaine gel, no counselling, monitor	Lidocaine gel	-
Lidocaine gel, counselling, no monitor	Lidocaine gel	-
Lubricating gel, counselling, monitor	Monitor	-
Lubricating gel, counselling, monitor	Lubricating gel	-
Lidocaine gel, no counselling, monitor	No counselling	-
Lidocaine gel, no counselling, no monitor	Lidocaine gel	-
Lubricating gel, counselling, no monitor	Counselling	-
Lubricating gel, counselling, no monitor	Lubricating gel	-
Lubricating gel, counselling, no monitor	No monitor	-
Lubricating gel, no counselling, monitor	No counselling	-
Lubricating gel, counselling, monitor	Counselling	-
Lubricating gel, no counselling, no monitor	Lubricating gel	-
Lidocaine gel, counselling, no monitor	No monitor	-
Lidocaine gel, no counselling, no monitor	No monitor	-
Lubricating gel, no counselling, no monitor	No monitor	-
Lidocaine gel, no counselling, monitor	Monitor	-
Lubricating gel, no counselling, monitor	Monitor	-
Lubricating gel, no counselling, monitor	Lubricating gel	-
Lubricating gel, no counselling, no monitor	No counselling	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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").

Trial Locations

Locations (1)

Klinik für Urologie, Kantonsspital Luzern; 🇨🇭 Lucerne, Switzerland