Clinical trial NCT06242600: Evaluation of Safety and Performance of the CytaCoat Lubricious Infection Prevention (LIP) Foley Catheter
Official title: A Prospective Single-center Randomized Pilot Study to Evaluate the Safety and Performance of the Novel CytaCoat LIP Foley Catheter When Compared to an Uncoated Foley Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Safety of the CytaCoat LIP Foley Catheter
Tolerability of the CytaCoat LIP Foley Catheter
Lead sponsor: CytaCoat AB
Sponsor class: INDUSTRY
First posted: 2024-02-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized 1:1 to CytaCoat LIP Foley catheter / uncoated silicone Foley catheter (15 patients in each arm).
Primary purpose: OTHER

Brief summary: The goal of this pilot safety and tolerability study is to determine whether the novel CytaCoat LIP (Lubricious Infection Prevention) Foley catheter is safe to use in patients during short term use.

The primary objective of this study is to determine the safety and tolerability for the medical device CytaCoat LIP Foley catheter in patients undergoing Transurethral Resection of the Bladder (TUR-B) surgery. Safety will be assessed by evaluation of adverse events.

The secondary objective is to assess the overall performance by evaluating if there were any Foley catheter handling problems experienced by the healthcare personnel with the use of the CytaCoat LIP Foley catheter.

Exploratory objectives are to assess bacterial culture of urine samples taken before and after catheterization and to assess pain, irritation and discomfort measured by asking patients about their experience using the catheter using a questionnaire.

Participants will be catheterized with either a CytaCoat Foley catheter or an uncoated silicone catheter, for a maximum of 24 hrs. After removal of the catheter, participants will be asked to assess if they experienced any pain, irritation and discomfort measured with the Numerical Rating Scale (NRS) (0-10). A similar assessment will be performed 7-10 days after removal of the catheter. In addition, the healthcare personnel will be asked to assess the functionality of the coated catheter with the NRS scale (0-10), using a questionnaire. Urine samples will be taken before and after catheterization and evaluated through quantification.


Eligibility criteria: Inclusion Criteria:

* Will be undergoing a TUR-B procedure.
* Able to give informed consent by signing and dating the written informed consent document acknowledging their desire to participate in the study.
* Adults, age 18 to 84 years.
* Require insertion of a size 12, 14, 16, 18 or 20 French Foley catheter after TUR-B surgery.
* Be able to understand and comply with the information given in the Patient Consent Form.

Exclusion Criteria:

* Vulnerable subjects such as children, pregnant or breastfeeding women, or potentially immune-compromised subjects.
* Unable to provide informed consent.
* Has a known bacteriuria or a current urinary tract infection.
* Has a known bloodstream infection or an infection that requires prolonged antibiotic therapy.
* Has an ongoing antibiotic therapy.
* Cannot accommodate a size 12, 14, 16, 18 or 20 Fr Foley catheter or requires a Thiemann tip Foley catheter.
* Previous enrolment in the present study.
* Simultaneous participation in another clinical study that may impact the primary endpoint.
* Severe non-compliance to protocol as judged by the PI.

Primary outcomes:
measure: Assessment of incidence of adverse events and serious adverse events (safety and tolerability) of the CytaCoat LIP Foley catheter
timeFrame: 1 - 10 days
Secondary outcomes:
measure: Assessment of the overall performance of the CytaCoat LIP Foley catheter
timeFrame: 1 - 10 days
Other outcomes:
measure: Exploratory assessment of bacterial culture of urine samples
timeFrame: 1 - 48 hours
measure: Exploratory assessment of patient user experience of the CytaCoat LIP Foley catheter
timeFrame: 1 - 10 days
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital, Department of Urology
name: Anders Andreasson, MD
role: PRINCIPAL_INVESTIGATOR
References: