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The aim of the investigation is to evaluate the subjects experience of a new collection device for men.
An open-labelled, single arm study design was chosen for this investigation with a duration of 1 week + up to 3 days extra.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urine Collection Device for Men | Experimental | Test of Urine Collection Device for Men for 7 (+/- 3/0 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urine collection device for men | Device | Use of urine collection device for men |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants That Found the Product to be Comfortable to Wear | Questionnaire used to measure the frequency of success in support of "comfortable": "How comfortable was the product to wear?". The question was asked at the end of the trial. | One week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Rasmussen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flying Nurses | Hillerød | 3400 | Denmark |
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There was no pre-assignment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Urine Collection Device for Men | Test of Urine Collection Device for Men for 7 (+/- 3/0 days). Urine collection device for men: Use of urine collection device for men |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Urine Collection Device for Men | Test of Urine Collection Device for Men for 7 (+/- 3/0 days). Urine collection device for men: Use of urine collection device for men |
| 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 | Percentage of Participants That Found the Product to be Comfortable to Wear | Questionnaire used to measure the frequency of success in support of "comfortable": "How comfortable was the product to wear?". The question was asked at the end of the trial. | ITT (electronic data from one subject was lost) | Posted | Number | 95% Confidence Interval | percentages of participants | One week |
|
|
1 week
Definition of adverse events are from ISO Standard 14155:2021.
Collection of AEs happened during the 1 week trial and when the subjects terminated their participations by the study nurse and by use of specific forms.
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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 | Urine Collection Device for Men | Test of Urine Collection Device for Men for 7 (+/- 3/0 days). Urine collection device for men: Use of urine collection device for men |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment | Red and sore skin. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Scientific Manager Marianne Raff Dambæk | Coloplast | 004549112562 | dkmr@coloplast.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2020 | Feb 6, 2024 | Prot_SAP_000.pdf |
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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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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 13 |
| 20 |
|
| Mild pain | Skin and subcutaneous tissue disorders | Systematic Assessment | Pain in the area of the product |
|
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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 |