Investigation of New Intermittent Catheters in Healthy Volunteers

Exploratory Investigation on Performance and Safety of New Intermittent Catheters in Healthy Volunteers

Investigation of non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.

The CP322 study investigated a novel non-CE marked intermittent catheter for males and females, designed in two different variants, Variant 1 and Variant 2, respectively. The study was conducted in Denmark and was a randomized, single blinded, cross-over investigation comparing the two new variant catheters with a comparator catheter in 30 adult healthy volunteers.

For each participant, the study thus contained three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 30 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:

• Minimum 18 years of age and with full legal capacity
• Written informed consent and signed letter of authority and secrecy agreement given
• Willing to comply with not using analgesics 1 up to 24 hours prior to catheterization visits
• Urine Multistix negative for erythrocytes (hematuria)

Exclusion Criteria:

• Participation in any other clinical investigations during this investigation
• Known hypersensitivity towards any of the test products
• Symptoms of urinary tract infection (UTI) (Investigators judgement)
• Pregnancy or breastfeeding