Spinal Cord Injury
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEIntermittent catheter CP063CC
intermittent catheterisation
DEVICESpeediCath
intermittent catheterisation
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years or older * Male * signed informed Consent, * Neg. urine multistix
Exclusion criteria
* Abnormalities, * diseases or surgical procedures performed in the lower urinary-tract
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discomfort Measured on the Visual Analog Scale (VAS) | 10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1 | Outcome measured on a 10 cm Visual Analog Scale ranging from no discomfort (0cm) to worst thinkable discomfort (10cm). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Irritation During Voiding After Catheterization | 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1 | 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. |
| Ease of Use Measured on a 5 Point Scale: Insertion Effort | 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1 | 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 |
| Ease of Use Measured on a 5 Point Scale: Withdrawal Effort | 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1 | 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 |
| Visible Blood | 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1 | 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. |
| Haematuria | 2 hours after catheterisation at visits 1 and 2 | Negative or positive result on a multistix urin analysis. Negative haematuria: 10 erythrocytes/microliter or less. Positive haematuria: above 10 erythrocytes/microliter. |
Countries
Denmark
Participant flow
Recruitment details
January-May, 2010, Department of Urology, Rigshospitalet, Denmark
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Includes groups randomized to receive SpeediCath first and Monza first | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Adverse Event | 1 | 0 |
| First Intervention | Lack of Efficacy | 1 | 1 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants |
| Age Continuous | 25.9 years STANDARD_DEVIATION 8.4 |
| Region of Enrollment Denmark | 41 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 41 |
| serious Total, serious adverse events | 0 / 41 |
Outcome results
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).
Time frame: 10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1
Population: Intention to Treat (ITT) population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Monza | Discomfort Measured on the Visual Analog Scale (VAS) | 3.7 cm | Standard Deviation 2.2 |
| SpeediCath | Discomfort Measured on the Visual Analog Scale (VAS) | 2.6 cm | Standard Deviation 1.8 |
p-value: 0.001895% CI: [0.412, 1.692]Mixed Models Analysis
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
Time frame: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Monza | Ease of Use Measured on a 5 Point Scale: Insertion Effort | Answer Easy | 16 participants |
| Monza | Ease of Use Measured on a 5 Point Scale: Insertion Effort | Answer Difficult | 6 participants |
| Monza | Ease of Use Measured on a 5 Point Scale: Insertion Effort | Answer Neither easy nor difficult | 13 participants |
| Monza | Ease of Use Measured on a 5 Point Scale: Insertion Effort | Answer Very Difficult | 1 participants |
| Monza | Ease of Use Measured on a 5 Point Scale: Insertion Effort | Answer Very Easy | 2 participants |
| SpeediCath | Ease of Use Measured on a 5 Point Scale: Insertion Effort | Answer Very Difficult | 0 participants |
| SpeediCath | Ease of Use Measured on a 5 Point Scale: Insertion Effort | Answer Very Easy | 7 participants |
| SpeediCath | Ease of Use Measured on a 5 Point Scale: Insertion Effort | Answer Easy | 20 participants |
| SpeediCath | Ease of Use Measured on a 5 Point Scale: Insertion Effort | Answer Neither easy nor difficult | 8 participants |
| SpeediCath | Ease of Use Measured on a 5 Point Scale: Insertion Effort | Answer Difficult | 4 participants |
p-value: 0.61695% CI: [0.382, 1.767]Proportional odds regression model
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
Time frame: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Monza | Ease of Use Measured on a 5 Point Scale: Withdrawal Effort | Answer Easy | 10 participants | — |
| Monza | Ease of Use Measured on a 5 Point Scale: Withdrawal Effort | Answer Difficult | 0 participants | — |
| Monza | Ease of Use Measured on a 5 Point Scale: Withdrawal Effort | Answer Neither easy nor difficult | 0 participants | — |
| Monza | Ease of Use Measured on a 5 Point Scale: Withdrawal Effort | Answer Very difficult | 0 participants | — |
| Monza | Ease of Use Measured on a 5 Point Scale: Withdrawal Effort | Answer Very Easy | 28 participants | 0.45 |
| SpeediCath | Ease of Use Measured on a 5 Point Scale: Withdrawal Effort | Answer Very difficult | 0 participants | — |
| SpeediCath | Ease of Use Measured on a 5 Point Scale: Withdrawal Effort | Answer Very Easy | 28 participants | 0.46 |
| SpeediCath | Ease of Use Measured on a 5 Point Scale: Withdrawal Effort | Answer Easy | 11 participants | — |
| SpeediCath | Ease of Use Measured on a 5 Point Scale: Withdrawal Effort | Answer Neither easy nor difficult | 0 participants | — |
| SpeediCath | Ease of Use Measured on a 5 Point Scale: Withdrawal Effort | Answer Difficult | 0 participants | — |
p-value: 0.801495% CI: [0.472, 2.646]Proportional odds regression model
Secondary
Haematuria
Negative or positive result on a multistix urin analysis. Negative haematuria: 10 erythrocytes/microliter or less. Positive haematuria: above 10 erythrocytes/microliter.
Time frame: 2 hours after catheterisation at visits 1 and 2
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Monza | Haematuria | Positive for haematuria | 10 participants |
| Monza | Haematuria | Negative for haematuria | 28 participants |
| SpeediCath | Haematuria | Positive for haematuria | 9 participants |
| SpeediCath | Haematuria | Negative for haematuria | 30 participants |
p-value: 0.432495% CI: [0.606, 3.225]Proportional odds regression model
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.
Time frame: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Monza | Irritation During Voiding After Catheterization | Answer Yes | 21 Participants |
| Monza | Irritation During Voiding After Catheterization | Answer No | 17 Participants |
| SpeediCath | Irritation During Voiding After Catheterization | Answer Yes | 7 Participants |
| SpeediCath | Irritation During Voiding After Catheterization | Answer No | 32 Participants |
p-value: <0.000195% CI: [2.604, 12.939]Regression, Logistic
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.
Time frame: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Monza | Visible Blood | Visible blood | 3 participants |
| Monza | Visible Blood | No visible blood | 35 participants |
| SpeediCath | Visible Blood | Visible blood | 1 participants |
| SpeediCath | Visible Blood | No visible blood | 38 participants |
p-value: 0.308595% CI: [0.314, 39.106]Regression, Logistic