Assessing Safety and Performance of the Novel CytaCoat Foley Catheter

Launched by CYTACOAT AB · Jul 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of urinary catheter called the CytaCoat Foley catheter. A urinary catheter is a small tube used to drain urine from the bladder when someone cannot do so naturally. The study aims to find out if this new catheter is safe to use and how well it works compared to a standard, uncoated catheter. Researchers will also look at how easy the catheter is to use, based on feedback from both healthcare workers and patients. Additionally, they will check the catheters after use to see if any bacteria or buildup has formed.

Adults aged 18 to 84 who need a urinary catheter for at least 3 days (up to 14 days) may be eligible to join the study. To participate, individuals must be able to use a standard catheter size and be awake and able to give consent. People who are pregnant, very ill, allergic to silicone, or already using a catheter for more than two days will not be able to join. If you take part, you will be randomly assigned to use either the new CytaCoat catheter or the usual catheter, and your health and comfort will be monitored during the time the catheter is in place. This study is currently looking for volunteers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults, male and female, aged 18 to 84 years
• • Subjects in need of a urinary catheter for a minimum of 72 hours
• • Subjects who can accommodate a size of 14, 16 and 18 French Foley catheter
• • Written informed consent
• • Subject to be conscious
• Exclusion Criteria:
• • Pregnant or breastfeeding women
• • Critically ill subjects with a life-threatening disorder (Subjects having an APACHE II score ≥ 28)
• • Subject with a known silicone allergy or sensitivity
• • Previous enrolment in the present study
• • Simultaneous participation in another clinical study that may impact the primary endpoint
• • Subject with pre-existing urinary catheter for more than 48 hours
• • Subject with symptomatic genitourinary pathology
• • Expected severe non-compliance to the protocol as judged by the principal investigator