Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
To evaluate discomfort of a new coating and catheter material compared to SpeediCath (SC)

Detailed Description
-----------------
Intermittent catheterization is the preferred method for emptying the bladder in patients with spinal cord injury and neurogenic bladder dysfunction. Coloplast have developed a new intermittent catheters. In this investigation this new test catheter will be compared with SpeediCat 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. 55 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
-----------------
Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Device: Intermittent catheterisation
* Device: NonCE marked intermittent catheter/red
* Device: NonCE marked intermittent catheter/green
* Device: NonCE marked intermittent catheter/blue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • ≥18 years Male Signed informed consent Negative urine stix (erythrocytes, leucocytes and nitrite) Exclusion Criteria: • Abnormalities, diseases or surgical procedures performed in the lower urinary tract

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active comparator/Yellow catheter<br>SpeediCath coated catheter | Device: Intermittent catheterisation<br>* Speedicath, Intermittent catheterisation<br>* Other names: SpeediCath;|
| Experimental: NonCE marked intermittent catheter/red<br> | Device: NonCE marked intermittent catheter/red<br>* Paris, Intermittent catheterisation<br>* Other names: Paris;|
| Experimental: NonCE marked intermittent catheter/green<br> | Device: NonCE marked intermittent catheter/green<br>* Paris, Intermittent catheter<br>* Other names: Paris;|
| Experimental: NonCE marked intermittent catheter/Blue<br> | Device: NonCE marked intermittent catheter/blue<br>* Paris, Intermittent catheter<br>* Other names: Paris;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discomfort during catheterisation measured by VAS-scale (0-10) | A subject is assesing a VAS scale after each catheterisation. | 10 measurements in an 11 week period. 10 min after each catheterisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Safety is evalueted continues while the subjects are testing the devices | During the investigation 11 Weeks per subject | 
| Discomfort during urination post catheterisation | Subjects own assesment. Yes or no can be answered to discomfort during urination post catheterisation | 10 measurements in an 11 week period. 10 min after each catheterisation | 
| Haematuria | Urine test after each catheterisation, and measured on a urine stix | 10 measurements in an 11 week period. 10 min after each catheterisation | 
| Handling during insertion, withdrawal | Ease of use assessed by nurses, measured on a 5 point scale | 10 measurements in an 11 week period. 10 min after each catheterisation |