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

Ajet Hyseni

Status: Unknown

Conditions: Flexible Cystoscopy

Treatments: Other: Counselling; Other: Monitor; Other: No counselling; Device: Lubricating gel; Other: No monitor; Device: Lidocaine gel

Study type: Interventional

Funder types: Other

Identifiers

NCT03874364

Lidocaine-study

Details and patient eligibility

About

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.

Enrollment: 280 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 8 patient groups, including a placebo group

Lidocaine gel, counselling, monitor

Active Comparator group

Treatment:

Device: Lidocaine gel

Other: Monitor

Other: Counselling

Lidocaine gel, counselling, no monitor

Active Comparator group

Treatment:

Other: No monitor

Device: Lidocaine gel

Other: Counselling

Lidocaine gel, no counselling, monitor

Active Comparator group

Treatment:

Device: Lidocaine gel

Other: Monitor

Other: No counselling

Lidocaine gel, no counselling, no monitor

Active Comparator group

Treatment:

Other: No monitor

Device: Lidocaine gel

Other: No counselling

Lubricating gel, counselling, monitor

Placebo Comparator group

Treatment:

Other: Monitor

Other: Counselling

Device: Lubricating gel

Lubricating gel, counselling, no monitor

Placebo Comparator group

Treatment:

Other: No monitor

Other: Counselling

Device: Lubricating gel

Lubricating gel, no counselling, monitor

Placebo Comparator group

Treatment:

Other: Monitor

Other: No counselling

Device: Lubricating gel

Lubricating gel, no counselling, no monitor

Placebo Comparator group

Treatment:

Other: No monitor

Other: No counselling

Device: Lubricating gel