Spinal Cord Injury
Conditions
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.
Interventions
DEVICEIntermittent catheterisation
Speedicath, Intermittent catheterisation
DEVICENonCE marked intermittent catheter/red
Paris, Intermittent catheterisation
DEVICENonCE marked intermittent catheter/green
Paris, Intermittent catheter
DEVICENonCE marked intermittent catheter/blue
Paris, Intermittent catheter
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discomfort during catheterisation measured by VAS-scale (0-10) | 10 measurements in an 11 week period. 10 min after each catheterisation | A subject is assesing a VAS scale after each catheterisation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | During the investigation 11 Weeks per subject | Safety is evalueted continues while the subjects are testing the devices |
| Discomfort during urination post catheterisation | 10 measurements in an 11 week period. 10 min after each catheterisation | Subjects own assesment. Yes or no can be answered to discomfort during urination post catheterisation |
| Haematuria | 10 measurements in an 11 week period. 10 min after each catheterisation | Urine test after each catheterisation, and measured on a urine stix |
| Handling during insertion, withdrawal | 10 measurements in an 11 week period. 10 min after each catheterisation | Ease of use assessed by nurses, measured on a 5 point scale |
Countries
Denmark
Outcome results
None listed