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Performance and acceptance of new intermittent catheters tested in healthy volunteers
This study is a single blinded, randomised, crossover study. The study period consists of an information visit, an inclusion visit, three test visits and a termination visit.
Two prototypes of intermittent catheters (Test product 2 and 3) compared to the standard catheter SpeediCath® Flex (Comparator).
In the investigation ten subjects will be included. The subjects will be catheterised once per visit. The subjects will be catheterised with the two test catheters and comparator in a randomised order. The order of the catheterisations will be randomised to prevent bias.
During the test visits the primary, secondary and explorative endpoints will be registered.
Subjects will be asked to participate in an interview in continuation of their last visit (Test Visit 3). The interviews will be performed by a Coloplast representative asking questions related to their experience with the catheter.
The subjects must sign a separate consent form for this purpose and can participate in the investigation without participating in the interview. In addition, subjects will be asked for consent to tape recording and filming during the interviews, but can participate in interviews without this.
In addition, a Coloplast representative will interview the Investigator and her representatives after LPO with questions related to their experience with the catheters.
The investigation is planned to be conducted in August 2018-Januar 2019. The visit window will be minimum five days between the visits (catheterisations), to ensure time for healing of any potential urethral trauma. However, the maximum time between visits should be adjusted to ensure the subject is terminated before LPO.
No biobank will be established for this investigation. All urine samples in the clinical investigation (for evaluating in- and exclusion criteria and for evaluating end points) will be destructed immediately after analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test product 2 | Experimental | Test catheter 2 |
|
| Test product 3 | Experimental | Test catheter 3 |
|
| Comparator | Active Comparator | SpeediCath Flex |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test product 2 | Device | Test catheter 2 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Urine Flow Rate | On day of study visits 1-5 rate of urine flow through catheter measured in mL/s | 2 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Post-void Residual Urine | On day of study visits 1-5 rate volume of urine left in the bladder post catheterisation (in mL) | 2 hour |
| Number of Participants With Hematuria | On day of study visits 1-5 blood in urine post catheterisation (measured as yes/no to blood in urine) |
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Inclusion Criteria:
Has given written informed consent and signed letter of authority Is at least 18 years of age and has full legal capacity Is a male Willing to comply without using analgetica up to 24 hours prior to catheterisation visits
Exclusion Criteria:
Has a previous history of genitourinary disease including congenital abnormalities and surgical procedures performed in the urinary tract Has symptoms of urinary tract infections (frequent urination, stinging and pain at urination) Are participating in any other clinical investigation related to urinary tract system during this investigation (inclusion to termination) Known hypersensitivity toward any of the test products
Subjects need a penis for male urinary catheter use
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| Name | Affiliation | Role |
|---|---|---|
| Birte Jakobsen, MD | Coloplast A/S | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coloplast A/S | Humlebæk | 3050 | Denmark |
9 out of 10 were randomized. The one not randomized did not meet the inclusion criteria.
10 subjects were screened for eligibility
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Product 2, Then Test Product 3, Then SpeediCath Flex | Participants were first catheterized with Test Product 2 at Visit 1. After a washout period of minimum 5 days, they were then catheterized with Test Product 3 at Visit 2. After a washout period of minimum 5 days again, they were then catheterized with SpeediCath Flex. |
| FG001 | Test Product 3, Then Test Product 2, Then SpeediCath Flex | Participants were first catheterized with Test Product 3 at Visit 1. After a washout period of minimum 5 days, they were then catheterized with Test Product 2 at Visit 2. After a washout period of minimum 5 days again, they were then catheterized with SpeediCath Flex. |
| FG002 | SpeediCath Flex, Then Test Product 2, Then Test Product 3 | Participants were first catheterized with SpeediCath Flex at Visit 1. After a washout period of minimum 5 days, they were then catheterized with Test Product 2 at Visit 2. After a washout period of minimum 5 days again, they were then catheterized with Test Product 3. |
| FG003 | Test Product 2, Then SpeediCath Flex, Then Test Product 3 | Participants were first catheterized with Test Product 2 at Visit 1. After a washout period of minimum 5 days, they were then catheterized with SpeediCath Flex at Visit 2. After a washout period of minimum 5 days again, they were then catheterized with Test Product 3. |
| FG004 | Test Product 3, Then SpeediCath Flex, Then Test Product 2 | Participants were first catheterized with Test Product 3 at Visit 1. After a washout period of minimum 5 days, they were then catheterized with SpeediCath Flex at Visit 2. After a washout period of minimum 5 days again, they were then catheterized with Test Product 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (Visit 1) |
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| Washout (Minimum 5 Days) |
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| Second Intervention (Visit 2) |
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| Washout (Minimum 5 Days) |
| |||||||||||||
| Third Intervention (Visit 3) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | The baseline measures include all study participants |
| 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 | Urine Flow Rate | On day of study visits 1-5 rate of urine flow through catheter measured in mL/s | Posted | Mean | Full Range | mL per second | 2 hour |
|
Two hours on days of study visits 1-6 and termination visit
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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 Product 2 | Test catheter 2 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Vice President | Coloplast A/S | +45 4911 1111 | clinical-studies@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 | Oct 18, 2022 | Feb 27, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Test product 3 |
| Device |
Test catheter 3 |
|
| Comparator | Device | SpeediCath Flex |
|
| 2 hour |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
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| COMPLETED |
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| NOT COMPLETED |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| 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 |
|
| Number of Participants with Hematuria at baseline | Count of number of participants with hematuria at baseline | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Post-void Residual Urine | On day of study visits 1-5 rate volume of urine left in the bladder post catheterisation (in mL) | Posted | Mean | Full Range | mL | 2 hour |
|
|
|
| Secondary | Number of Participants With Hematuria | On day of study visits 1-5 blood in urine post catheterisation (measured as yes/no to blood in urine) | Posted | Count of Participants | Participants | No | 2 hour |
|
|
|
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Test Product 3 | Test catheter 3 | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | Comparator | SpeediCath Flex | 0 | 8 | 0 | 8 | 0 | 8 |
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