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Investigation of novel swelling media for CE marked intermittent urinary catheters. The study was a randomized, single blinded, cross-over investigation comparing a novel swelling media with a comparator swelling media in 22 adult, healthy, male volunteers.
The CP279 study investigated a novel swelling media for male intermittent urinary catheters. The study was conducted in Denmark and was a single-site, randomized, single blinded, cross-over investigation, testing inferiority of a novel catheter swelling media against a comparator swelling media in 22 adult, healthy, male volunteers.
Each participant was randomized to one of two treatment arms, using a randomization sequence of two (i.e., with two different random options for the order in which the participants tested the two swelling media). The study thus contained two test visits, for which the 22 participants tested the two different swelling media, respectively. There was 4-14 days between the test visits and all catheterizations were performed by trained nurses. Due to a visual difference between the products, it was only possible to blind the subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel swelling media | Experimental | Participants underwent catheterization with the SpeediCath standard male catheter containing the novel swelling media. The catheterization was performed by a trained nurse. |
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| Comparator swelling media | Active Comparator | Participants underwent catheterization with CE-marked SpeediCath® standard male containing the original swelling media. The catheterization was performed by a trained nurse. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel swelling media | Device | Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Discomfort During Nurse Catheterization | Discomfort measured for the entire catheterization procedure (performed by nurse), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score. | Immediately after the procedure/catheterization, up to 5 min. |
| Measure | Description | Time Frame |
|---|---|---|
| Insertion Discomfort During Nurse Catheterization | Discomfort measured for the entire catheterization procedure (performed by nurse), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Bagi, MD | Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark | Copenhagen | København Ø | 2100 | Denmark |
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The 22 recruited participant were randomized into the two intervention arms, i.e., using a randomization sequence of two. No participants were excluded and none were discontinued.
Thus, 22 participants constituted the safety and the intention to treat (ITT) population.
During November 2019, 22 users were recruited for the study from one site (Denmark) and encompassed the safety population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Original Swelling Media, Then Novel Swelling Media | On two separate and randomly assigned visits, the participants underwent two interventions: First intervention: Day of catheterization with original swelling media (Comparator). Washout: 4-14 days. Second intervention: Day of catheterization with novel swelling media (Test device). |
| FG001 | Novel Swelling Media, Then Original Swelling Media | On two separate and randomly assigned visits, the participants underwent two interventions: First intervention: Day of catheterization with novel swelling media (Test device). Washout: 4-14 days. Second intervention: Day of catheterization with original swelling media (Comparator). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Total ITT Population | Each treatment arm consisted of two test visits with 4-14 washout days between each crossover. On each visit, the participants underwent intermittent catheterization through the urethra, draining the bladder, and tested a different intermittent catheter: The comparator catheter (SpeediCath® Standard male with original swelling media) or the test catheter (SpeediCath® Standard male with novel swelling media). All catheterizations were performed by a trained nurse. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Overall Discomfort During Nurse Catheterization | Discomfort measured for the entire catheterization procedure (performed by nurse), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score. | The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoint. | Posted | Mean | Standard Deviation | cm | Immediately after the procedure/catheterization, up to 5 min. |
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Each participant was enrolled for 5-15 days for the entire investigation, thus a maximum of 15 days.
The relationship to the investigational or comparator products was collected. The safety population constituted the subjects who had given informed consent and were thus 22 participants.
An adverse event was reported as either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the intervention.
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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 | Novel Swelling Media | Participants underwent catheterization with the SpeediCath standard male catheter containing the novel swelling media. The catheterization was performed by a trained nurse. Novel swelling media: Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Medical Affairs | Coloplast A/S | +4549111111 | 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 | Aug 5, 2019 | Aug 16, 2022 | Prot_SAP_000.pdf |
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| Comparator swelling media | Device | Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse. |
|
| Immediately after the procedure/catheterization, up to 5 min. |
| Withdrawal Discomfort During Nurse Catheterization | Discomfort measured for the entire catheterization procedure (performed by nurse), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score. | Immediately after the procedure/catheterization, up to 5 min. |
| Urination Discomfort After Catheterization | Discomfort measured for the entire catheterization procedure (performed by nurse), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score. | Immediately after first normal void, up to 5 min. |
| Catheter Handling During Insertion | Nurse evaluation of how he/she experienced catheter insertion on a 5-point likert scale including the options: Very difficult, difficult, neither difficult nor easy, easy or very easy. | Immediately after the procedure/catheterization, up to 5 min. |
| Catheter Handling During Withdrawal | Nurse evaluation of how he/she experienced catheter withdrawal on a 5-point likert scale including the options: Very difficult, difficult, neither difficult nor easy, easy or very easy. | Immediately after the procedure/catheterization, up to 5 min. |
| Touch of Catheter Coating | Nurse evaluation of whether or not it was needed to touch the catheter coating during handling and/or catheterization (yes/no). | Immediately after the procedure/catheterization, up to 5 min. |
| Visual Blood During Catheterization | Nurse evaluation of if he/she experienced visual blood on either the catheter or in the urine during catheterization (yes/no). | Immediately after the procedure/catheterization, up to 5 min. |
| Microscopic Blood in Catheter-collected Urine | Dipstick analysis of hematuria (erythrocytes) after catheterization using a semi-quantitative color scale with five categories ranging from negative to 3+: Negative (-). 10 erythrocytes/μL (+/-). 25 erythrocytes/μL (1+). 80 erythrocytes/μL (2+). 200 erythrocytes/μL (3+). At least one fully positive response (i.e., either 1+, 2+ or 3+), the endpoint was considered positive and the outcome was analyzed as a binary response (positive/negative). | Immediately after the procedure/catheterization, up to 30 min. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Number of participants with presence of hematuria (microscopic) | Count of Participants | Participants |
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Participants underwent catheterization with the SpeediCath standard male catheter containing the novel swelling media. The catheterization was performed by a trained nurse. Novel swelling media: Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse. |
| OG001 | Comparator Swelling Media | Participants underwent catheterization with CE-marked SpeediCath® standard male containing the original swelling media. The catheterization was performed by a trained nurse. Comparator swelling media: Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse. |
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| Secondary | Insertion Discomfort During Nurse Catheterization | Discomfort measured for the entire catheterization procedure (performed by nurse), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score. | The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoint. | Posted | Mean | Standard Deviation | cm | Immediately after the procedure/catheterization, up to 5 min. |
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| Secondary | Withdrawal Discomfort During Nurse Catheterization | Discomfort measured for the entire catheterization procedure (performed by nurse), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score. | The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoint. | Posted | Mean | Standard Deviation | cm | Immediately after the procedure/catheterization, up to 5 min. |
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| Secondary | Urination Discomfort After Catheterization | Discomfort measured for the entire catheterization procedure (performed by nurse), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score. | The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoint. | Posted | Mean | Standard Deviation | cm | Immediately after first normal void, up to 5 min. |
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| Secondary | Catheter Handling During Insertion | Nurse evaluation of how he/she experienced catheter insertion on a 5-point likert scale including the options: Very difficult, difficult, neither difficult nor easy, easy or very easy. | The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoint. | Posted | Count of Participants | Participants | Immediately after the procedure/catheterization, up to 5 min. |
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| Secondary | Catheter Handling During Withdrawal | Nurse evaluation of how he/she experienced catheter withdrawal on a 5-point likert scale including the options: Very difficult, difficult, neither difficult nor easy, easy or very easy. | The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoint. | Posted | Count of Participants | Participants | Immediately after the procedure/catheterization, up to 5 min. |
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| Secondary | Touch of Catheter Coating | Nurse evaluation of whether or not it was needed to touch the catheter coating during handling and/or catheterization (yes/no). | The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoint. | Posted | Count of Participants | Participants | Immediately after the procedure/catheterization, up to 5 min. |
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| Secondary | Visual Blood During Catheterization | Nurse evaluation of if he/she experienced visual blood on either the catheter or in the urine during catheterization (yes/no). | The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoint. | Posted | Count of Participants | Participants | Immediately after the procedure/catheterization, up to 5 min. |
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| Secondary | Microscopic Blood in Catheter-collected Urine | Dipstick analysis of hematuria (erythrocytes) after catheterization using a semi-quantitative color scale with five categories ranging from negative to 3+: Negative (-). 10 erythrocytes/μL (+/-). 25 erythrocytes/μL (1+). 80 erythrocytes/μL (2+). 200 erythrocytes/μL (3+). At least one fully positive response (i.e., either 1+, 2+ or 3+), the endpoint was considered positive and the outcome was analyzed as a binary response (positive/negative). | The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoint. | Posted | Count of Participants | Participants | Immediately after the procedure/catheterization, up to 30 min. |
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| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Comparator Swelling Media | Participants underwent catheterization with CE-marked SpeediCath® standard male containing the original swelling media. The catheterization was performed by a trained nurse. Comparator swelling media: Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse. | 0 | 22 | 0 | 22 | 0 | 22 |
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| Non-Inferiority |
Based on previous studies, the weighted average VAS discomfort level in healthy subjects using SpeediCath®Standard male was estimated at 2.3 cm, with 50% increase in VAS was considered clinically relevant. The mean difference non-inferiority margin between catheter coatings was therefore set to 1.2 cm, and non-inferiority was demonstrated if the mean difference was not above 1.2 cm. |
| Non-Inferiority |
Based on previous studies, the weighted average VAS discomfort level in healthy subjects using SpeediCath®Standard male was estimated at 2.3 cm, with 50% increase in VAS was considered clinically relevant. The mean difference non-inferiority margin between catheter coatings was therefore set to 1.2 cm, and non-inferiority was demonstrated if the mean difference was not above 1.2 cm. |
| Non-Inferiority |
Based on previous studies, the weighted average VAS discomfort level in healthy subjects using SpeediCath®Standard male was estimated at 2.3 cm, with 50% increase in VAS was considered clinically relevant. The mean difference non-inferiority margin between catheter coatings was therefore set to 1.2 cm, and non-inferiority was demonstrated if the mean difference was not above 1.2 cm. |
| Neither difficult nor easy |
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| Difficult |
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| Very difficult |
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| Superiority |
| Neither difficult nor easy |
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| Difficult |
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| Very difficult |
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| Superiority |
| Superiority |
| Superiority |
| Superiority |