New Coating for Urinary Intermittent Catheters

The primary objective of the study is to confirm that the newly developed investigational coating is non-inferior to the comparator coating with respect to the overall discomfort of catheterisation.

The investigational device is a ready-to-use, sterile, hydrophilic-coated Nelaton male catheter for intermittent catheterisation and based on the standard SpeediCath® male intermittent catheter with a difference in the composition on the coating.

The study is a double-blinded, randomized, crossover study including 32 randomized healthy male volunteers. The total study duration for the individual subject will be between 4-21 days and consists of 3 site visits V0, V1 and V2, and V0 andV1 can be combined

At V1 and V2 the subjects will be catheterized in a hospital setting by a health care professional, with one of the two catheters in a randomized order. Subject will be asked to assess the overall discomfort of the catheterisation on VAS.

Inclusion criteria

• Has given written informed consent
• Is at least 18 years old
• Has full legal capacity
• Has self-assessed intact male anatomy with no abnormalities or disease of the lower urinary tract or any surgical procedures performed in the lower urinary tract
• Is able (assessed by investigator) and willing to adhere to study procedures during study duration.
• Is able to refrain from using analgesics up to 24 hours prior to catheterisation visits
• Is negative for haematuria, measured by urine dipstick test of erythrocytes

Exclusion criteria

• Is participating in any other clinical investigation during this investigation, which could affect the results of this investigation, as assessed by investigator.
• Has previously been randomized in this investigation.
• Has known hypersensitivity towards any of the devices used in the investigation
• Is currently experiencing symptoms associated with UTI, as assessed by investigator.
• Has known impaired sensation of the urethra