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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine gel, counselling, monitor | Active Comparator |
| |
| Lidocaine gel, counselling, no monitor | Active Comparator |
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| Lidocaine gel, no counselling, monitor | Active Comparator |
| |
| Lidocaine gel, no counselling, no monitor | Active Comparator |
| |
| Lubricating gel, counselling, monitor | Placebo Comparator |
| |
| Lubricating gel, counselling, no monitor | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine gel | 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. |
| 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 |
| 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"). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ajet Hyseni, Dr.med.univ.RKS | Contact | 0+41 41 205 6959 | ajet.hyseni@luks.ch | |
| Carlo Di Bona | Contact | +41 41 205 6308 | carlo.dibona@luks.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Urologie, Kantonsspital Luzern | Recruiting | Lucerne | 6000 | Switzerland |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| Lubricating gel, no counselling, monitor | Placebo Comparator |
|
| Lubricating gel, no counselling, no monitor | Placebo Comparator |
|
| Counselling | Other | Patients receive a brochure in the waiting room explaining the procedure in details. |
|
| Monitor | Other | Patients are allowed to view and follow the procedure on a monitor connected to the cystoscope's camera. |
|
| Lubricating gel | 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 | Other | Patients won't receive a brochure in the waiting room explaining the procedure in details. |
|
| No monitor | Other | Patients are not allowed to view and follow the procedure on a monitor connected to the cystoscope's camera. |
|
| 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 |
| D005159 | Health Care Facilities Workforce and Services |