Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparative Study of Two Different Urine Catheters.

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Device: Intermittent catheter CP063CC
* Device: SpeediCath


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monza<br>nonCE marked intermittent catheter | Device: Intermittent catheter CP063CC<br>* intermittent catheterisation<br>* Other names: Intermittent catheter,;|
| Active Comparator: control<br>SpeediCath coated catheter | Device: Intermittent catheter CP063CC<br>* intermittent catheterisation<br>* Other names: Intermittent catheter,;Device: SpeediCath<br>* intermittent catheterisation<br>* Other names: Intermittent catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |