To evaluate discomfort of a new coating and catheter material compared to SpeediCath (SC)
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Speedicath, Intermittent catheterisation
Paris, Intermittent catheterisation
Paris, Intermittent catheter
Rigshospitalet
Copenhagen, Denmark
Discomfort during catheterisation measured by VAS-scale (0-10)
A subject is assesing a VAS scale after each catheterisation.
Time frame: 10 measurements in an 11 week period. 10 min after each catheterisation
Safety
Safety is evalueted continues while the subjects are testing the devices
Time frame: 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
Time frame: 10 measurements in an 11 week period. 10 min after each catheterisation
Haematuria
Urine test after each catheterisation, and measured on a urine stix
Time frame: 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
Time frame: 10 measurements in an 11 week period. 10 min after each catheterisation
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Paris, Intermittent catheter