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

NCT ID: NCT03874364

Last Updated: 2019-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2021-01-31

Brief Summary

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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

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Conditions

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Flexible Cystoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Lidocaine gel, counselling, monitor

Group Type ACTIVE_COMPARATOR

Lidocaine gel

Intervention Type DEVICE

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.

Counselling

Intervention Type OTHER

Patients receive a brochure in the waiting room explaining the procedure in details.

Monitor

Intervention Type OTHER

Patients are allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.

Lidocaine gel, counselling, no monitor

Group Type ACTIVE_COMPARATOR

Lidocaine gel

Intervention Type DEVICE

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.

Counselling

Intervention Type OTHER

Patients receive a brochure in the waiting room explaining the procedure in details.

No monitor

Intervention Type OTHER

Patients are not allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.

Lidocaine gel, no counselling, monitor

Group Type ACTIVE_COMPARATOR

Lidocaine gel

Intervention Type DEVICE

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.

Monitor

Intervention Type OTHER

Patients are allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.

No counselling

Intervention Type OTHER

Patients won't receive a brochure in the waiting room explaining the procedure in details.

Lidocaine gel, no counselling, no monitor

Group Type ACTIVE_COMPARATOR

Lidocaine gel

Intervention Type DEVICE

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.

No counselling

Intervention Type OTHER

Patients won't receive a brochure in the waiting room explaining the procedure in details.

No monitor

Intervention Type OTHER

Patients are not allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.

Lubricating gel, counselling, monitor

Group Type PLACEBO_COMPARATOR

Counselling

Intervention Type OTHER

Patients receive a brochure in the waiting room explaining the procedure in details.

Monitor

Intervention Type OTHER

Patients are allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.

Lubricating gel

Intervention Type DEVICE

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.

Lubricating gel, counselling, no monitor

Group Type PLACEBO_COMPARATOR

Counselling

Intervention Type OTHER

Patients receive a brochure in the waiting room explaining the procedure in details.

Lubricating gel

Intervention Type DEVICE

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.

No monitor

Intervention Type OTHER

Patients are not allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.

Lubricating gel, no counselling, monitor

Group Type PLACEBO_COMPARATOR

Monitor

Intervention Type OTHER

Patients are allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.

Lubricating gel

Intervention Type DEVICE

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.

No counselling

Intervention Type OTHER

Patients won't receive a brochure in the waiting room explaining the procedure in details.

Lubricating gel, no counselling, no monitor

Group Type PLACEBO_COMPARATOR

Lubricating gel

Intervention Type DEVICE

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.

No counselling

Intervention Type OTHER

Patients won't receive a brochure in the waiting room explaining the procedure in details.

No monitor

Intervention Type OTHER

Patients are not allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.

Interventions

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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.

Intervention Type DEVICE

Counselling

Patients receive a brochure in the waiting room explaining the procedure in details.

Intervention Type OTHER

Monitor

Patients are allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.

Intervention Type OTHER

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.

Intervention Type DEVICE

No counselling

Patients won't receive a brochure in the waiting room explaining the procedure in details.

Intervention Type OTHER

No monitor

Patients are not allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ajet Hyseni

OTHER

Sponsor Role lead

Responsible Party

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Ajet Hyseni

Dr.med.univ.RKS

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Klinik für Urologie, Kantonsspital Luzern

Lucerne, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Ajet Hyseni, Dr.med.univ.RKS

Role: CONTACT

0+41 41 205 6959

Carlo Di Bona

Role: CONTACT

+41 41 205 6308

Facility Contacts

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Carlo Di Bona

Role: primary

+41 41 205 6308

Other Identifiers

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Lidocaine-study

Identifier Type: -

Identifier Source: org_study_id

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