Spinal Cord Injury Clinical Trial
Official title:
Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care
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