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The purpose of this study is to evaluate the safety of an intermittent catheter in comparison with an already existing catheter on the market. The study is a randomised, single blinded, cross-over study including 25 healthy males.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Other | SCCM (SpeediCath Compact Male catheter) then SC (SpeediCath cathter) on test day 1. SC then SCCM on test day 2 |
|
| Group B | Other | SC (SpeediCath cathter)then SCCM (SpeediCath Compact Male catheter) on test day 1. SCCM then SC on test day 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpeediCath Compact Male | Device | CH 12 hydrophilic coated intermitten compact catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Discomfort | Discomfort measured on a Visual Analog Scale (VAS) from 0 (no discomfort) to 10 (worst imaginable discomfort) | After each catheterisation |
| Measure | Description | Time Frame |
|---|---|---|
| Handling | After each catheterisation | |
| Preference | At study termination | |
| Haematuria |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshopsitalet | Copenhagen | København Ø | 2100 | Denmark |
28 participants enrolled in study. 2 were excluded before randomization as they did not comply with inclusion criteria. One was excluded from study (ITT) as participants dropped out before having any data recorded.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | Test day 1: first SCCM then SC; Test day 2: first SC then SCCM; this gives 4 catherizations per participant |
| FG001 | Group B | Test day 1 first SC then SCCM; Test day 2 first SCCM then SC; this gives 4 catherizations per participant |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Test Day 1- 1 Period |
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| Test Day 1-2 Period |
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| Test Day 2 - 1 Period |
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| Test Day 2 - 2 Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Discomfort | Discomfort measured on a Visual Analog Scale (VAS) from 0 (no discomfort) to 10 (worst imaginable discomfort) | The number analized was the number of participants catherised with each catheter at least onze during the study(SC or SCCM) | Posted | Mean | Standard Deviation | units on a scale | After each catheterisation |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Catheter |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scientific Manager | Coloplast | +4549113557 | dkkg@coloplast.com |
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| Speedicath | Device | CH 12 hydrophilic coated intermittent coated catheter |
|
| After each catheterisation |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Handling | Not Posted | After each catheterisation |
| Secondary | Preference | Not Posted | At study termination |
| Secondary | Haematuria | Not Posted | After each catheterisation |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Standard Catheter | 0 | 25 | 0 | 25 |
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