Investigation of Non-CE Marked Intermittent Catheters.

Exploratory Investigation on Performance and Safety of Newly Developed Intermittent Catheters in Male Users of Intermittent Catheters

Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for males with a comparator catheter

The CP323 study investigated a novel non-CE marked intermittent catheter, designed in two different variants, Variant 1 and Variant 2, respectively, and was conducted in Denmark. The study was a randomized, single blinded, cross-over investigation, comparing the two new variant catheters with a comparator catheter in 15 male IC users.

For each participant, the study thus contains three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 15 participants were randomized using a randomization sequence of six (i.e., there were six different random options for the order in which the participants tested the three catheters). There were 4-14 days between the test visits.

Inclusion Criteria:

• Male
• Minimum 18 years of age and with full legal capacity
• Daily intermittent catheterization for bladder management, with at least two catheters used on average pr. day, during the last 3 months
• Ability to self-catheterize
• Written informed consent, signed letter of authority and signed secrecy agreement given

Exclusion Criteria:

• Participation in any other clinical study during this investigation
• Symptoms of urinary tract infection as judged by the investigator
• Any know allergies towards ingredients in the products
• Relevant medical history that would prevent the subject from participation in the investigation (investigators judgement)