Spinal Cord Injury Clinical Trial
Official title:
Comparative Study of Two Different Urine Catheters.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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