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The purpose of this study is to evaluate the safety of a new developed catheter in comparison with an catheter on the market. The study is randomised.
Intermittent catheterization is the preferred method for emptying the bladder in patients with spinal cord injury and neurogenic bladder dysfunction.
Coloplast has developed a new intermittent catheter. In this investigation this new test catheter will be compared with SpeediCath by assessing discomfort and pain associated with catheterization of healthy men. The reason for choosing healthy men is that many catheter users do not have full feeling in their urethra and therefore can not assess the discomfort.
Healthy men who are ≥ 18 years and have no signs of urinary tract infection and do not have abnormalities, disease or have had operational interventions in the urinary tract will be included. They are recruited through advertisements on the website www.forsoegsperson.dk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monza | Experimental | nonCE marked intermittent catheter |
|
| control | Active Comparator | SpeediCath coated catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent catheter CP063CC | Device | intermittent catheterisation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Discomfort Measured on the Visual Analog Scale (VAS) | Outcome measured on a 10 cm Visual Analog Scale ranging from "no discomfort" (0cm) to "worst thinkable discomfort" (10cm). | 10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Irritation During Voiding After Catheterization | After each catheterization subjects were asked if they felt any irritation during voiding with answer option yes or no. Yes - they experienced irritation. No - they did not experience irritation. | 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rikke Otttesen, CTM | Coloplast A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet, dep. 2112 | Copenhagen | 2100 | Denmark |
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January-May, 2010, Department of Urology, Rigshospitalet, Denmark
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| ID | Title | Description |
|---|---|---|
| FG000 | SpeediCath First, Then Monza | Catheterization with SpeediCath catheter on visit 1. Catheterization with Monza catheter on visit 2. |
| FG001 | Monza First, Then SpeediCath | Catheterization with Monza catheter on visit 1. Catheterization with SpeediCath catheter on visit 2. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive SpeediCath first and Monza first |
| 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 Measured on the Visual Analog Scale (VAS) | Outcome measured on a 10 cm Visual Analog Scale ranging from "no discomfort" (0cm) to "worst thinkable discomfort" (10cm). | Intention to Treat (ITT) population | Posted | Mean | Standard Deviation | cm | 10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1 |
|
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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 | Entire Study Population | Includes groups randomized to receive SpeediCath first and Monza first |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment | Not related to the device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trine Møller Kruse | Clinical Regulatory Development, Global R&D | +4549112174 | dktrm@coloplast.com |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| SpeediCath | Device | intermittent catheterisation |
|
|
| Ease of Use Measured on a 5 Point Scale: Insertion Effort | After each catheterization the nurse who conducted the catheterization answered how the catheter insertion had been. There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy | 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1 |
| Ease of Use Measured on a 5 Point Scale: Withdrawal Effort | After each catheterization the nurse who conducted the catheterization answered how the catheter withdrawal had been. There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy | 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1 |
| Visible Blood | Visual blood observed on the catheter or in the urine in connection to catheterization. The nurse who conducted the catheterization could answer yes or no as follows: Yes = visible blood observed. No = no visible blood observed. | 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1 |
| Haematuria | Negative or positive result on a multistix urin analysis. Negative haematuria: 10 erythrocytes/microliter or less. Positive haematuria: above 10 erythrocytes/microliter. | 2 hours after catheterisation at visits 1 and 2 |
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|
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
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| Secondary | Irritation During Voiding After Catheterization | After each catheterization subjects were asked if they felt any irritation during voiding with answer option yes or no. Yes - they experienced irritation. No - they did not experience irritation. | ITT | Posted | Number | Participants | 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1 |
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| Secondary | Ease of Use Measured on a 5 Point Scale: Insertion Effort | After each catheterization the nurse who conducted the catheterization answered how the catheter insertion had been. There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy | ITT | Posted | Number | participants | 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1 |
|
|
|
|
| Secondary | Ease of Use Measured on a 5 Point Scale: Withdrawal Effort | After each catheterization the nurse who conducted the catheterization answered how the catheter withdrawal had been. There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy | ITT | Posted | Number | participants | 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1 |
|
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|
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| Secondary | Visible Blood | Visual blood observed on the catheter or in the urine in connection to catheterization. The nurse who conducted the catheterization could answer yes or no as follows: Yes = visible blood observed. No = no visible blood observed. | ITT | Posted | Number | participants | 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1 |
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| Secondary | Haematuria | Negative or positive result on a multistix urin analysis. Negative haematuria: 10 erythrocytes/microliter or less. Positive haematuria: above 10 erythrocytes/microliter. | ITT | Posted | Number | participants | 2 hours after catheterisation at visits 1 and 2 |
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| 0 |
| 41 |
| 1 |
| 41 |
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| D014947 | Wounds and Injuries |
| Answer "Neither easy nor difficult" |
|
| Answer "Difficult" |
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| Answer "Very Difficult" |
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| Answer "Neither easy nor difficult" |
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| Answer "Difficult" |
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| Answer "Very difficult" |
|