Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers

2014-08-27 03:13:01 | BioPortfolio


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 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.

40 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

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Spinal Cord Injury


Intermittent catheter CP063CC, SpeediCath


Rigshospitalet, dep. 2112




Coloplast A/S

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:13:01-0400

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