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The aim of the study is to investigate the navigation of a newly developed catheter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testing the new Coloplast Test catheter | Experimental | The subjects used the new Coloplast Test catheter for 1 week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coloplast test catheter | Device | This is a newly developed catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Successfully Able to Insert Catheter | The subjects had to evaluate if it was possible to insert and navigate the Coloplast Test catheter through urethra by the 5-point Likert question: "How did you find the catheter navigates through the urethra during insertion" ( Very easily, Easily, Neither/nor, Difficultly, Very difficultly, Not possible). The catheterization was considered successful if it was possible to insert the catheter, meaning that ifthey selected any other answer than 'not possible'. | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Camilla F Vibjerg, Msc | Head of clinical operation | Study Chair |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tiemann/Coudé Users | The Tiemann/Coudé users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial. Coloplast test catheter: This is a newly developed catheter |
| FG001 | Traditional Sleeve Catheter Users | The traditional sleeve catheter users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Inclusion Visit |
|
| ||||||||||||||||||
| Test Period |
|
All the subjects enrolled in the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Tiemann/Coudé Users | The Tiemann/Coudé users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial. Coloplast test catheter: This is a newly developed catheter |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Number of Participants Successfully Able to Insert Catheter | The subjects had to evaluate if it was possible to insert and navigate the Coloplast Test catheter through urethra by the 5-point Likert question: "How did you find the catheter navigates through the urethra during insertion" ( Very easily, Easily, Neither/nor, Difficultly, Very difficultly, Not possible). The catheterization was considered successful if it was possible to insert the catheter, meaning that ifthey selected any other answer than 'not possible'. | Posted | Count of Participants | Participants | 1 week |
|
Adverse events were collected during the trial period
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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 | Tiemann/Coudé Users | The Tiemann/Coudé users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial. Coloplast test catheter: This is a newly developed catheter |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of clinical operations | Clinical operations,Medical Affairs | +45 49113267 | dkphl@coloplast.com |
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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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| NOT COMPLETED |
|
| BG001 | Traditional Sleeve Catheter Users | The traditional sleeve catheter users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Traditional Sleeve Catheter Users | The traditional sleeve catheter users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial. |
|
|
| 0 |
| 95 |
| 0 |
| 95 |
| 0 |
| 95 |
| EG001 | Traditional Sleeve Catheter Users | The traditional sleeve catheter users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial. | 0 | 58 | 0 | 58 | 0 | 58 |
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| 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 |