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The aim of the study is to test the performance and safety of a newly developed intermittent catheter in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Coloplast Test catheter; then Speedicath catheter | Experimental | The subjects allocated to this arm first test Coloplast Test catheter and after cross over test the comparator speedicath catheter |
|
| First Speedicath catheter; then Coloplast Test catheter | Experimental | The subjects allocated to this arm first test Speedicath catheter and after cross over test the Coloplast test catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coloplast Test Catheter | Device | Newly developed intermittent catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain | The VAS scale is used to measure the pain experienced by the subjects at catheterisation | 1 day |
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Inclusion Criteria:
Have given written informed consent and signed letter of authority
Be at least 18 years of age and have full legal capacity
Be a male
Willing to refrain from using analgetics up to 24 hours prior to catheterization visits
Have a negative urine multistix - erythrocytes (Microscopic haematuria)
Have a negative urine multistix:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Bagi, MD | MD at the clinic of urology at Rigshospitalet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Coppenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Coloplast Speedicath | Device | Marketed Coloplast Speedicath catheter |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |