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The aim of the study is to test the performance and safety of a newly developed intermittent catheter
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Coloplast Test Catheter; then Speedicath | Experimental | The subjects allocated to this arm first test Coloplast Test Catheter and then after cross over test the comparator Speedicath Catheter |
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| First Speedicath; then Coloplast Test Catheter | Experimental | The subjects allocated to this arm first test Speedicath Catheter and then after cross over test Coloplast Test Catheter |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coloplast Test Catheter | Device | This is a newly developed intermittent catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Pain experienced by the subjects at catheterisation is measure with the VAS scale | 1 day |
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Inclusion Criteria:
1. Have given written informed consent and signed letter of authority 2. Be at least 18 years of age and have full legal capacity 3. Be a male 4. Willing to refrain from using analgetics up to 24 hours prior to catheterization visits 5. Have a negative urine multistix - erythrocytes (Microscopic haematuria) 6. Have a negative urine multistix:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Bagi, MD | MD at the clinic for urology at Rigshospitalet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshopsitalet | Copenhagen | København Ø | 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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| Speedicath | Device | This is a marketed Catheter which is used as comparator |
|
| 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 |