Short summary

This study aims to investigate whether catheter flushing with Uro-Tainer® SubyG and Uro-Tainer® Polihexanide can reduce catheter changes due to incrustation and blockage compared to the normally used Saline flushing. In addition, a list of secondary aims inclusive of cost-effectiveness analysis, infection prevention and quality of life will be investigated. Expected clinical benefits: Less catheter blockage -> less need for unscheduled catheter replacement -> Fewer infections and better QoL

Rationale

Patients with permanent catheters are at high risk of complications such as catheter-associated urinary tract infections (CAUTI) and catheter calcifications/blockages. Blockage can lead to urine leakage along the catheter, discomfort in the bladder and urethra, and odour nuisances contributing to social embarrassment for the patient. At least 50% of catheterized patients suffer from incrustations (calcifications), which are one of the main causes of blockage and may require the catheter to be replaced prematurely. Since the majority of patients living with a permanent catheter are elderly or have long-term disabilities, this can have a significant impact on their quality of life.

Catheter change due to incrustations can be diminished by using Uro-Tainer® with citric acid (Suby G) instead of Saline flushing as shown in an observations study from 2011. They found that the catheter change pattern changed from 1 to 2 weeks to 4 to 8 weeks.

Some patients experience catheter obstruction which cannot be characterized as incrustations. These are more often debris, mucus and small remnants of blood that cause catheter blockage. This causes a need to flush the catheter to remove the blockage. Intestinal bacteria such as Escherichia coli are the most common (80%), but Pseudomonas species, Enterococcus and a lot of other species are also known to cause infection. Bacteria rapidly develop into colonies known as 'biofilms' that adhere to the catheter surface and urine bag. Biofilm can cause problems, especially if the bacteria produce the enzyme urease, as Proteus mirabilis does. The urine becomes alkaline, causing crystallization of calcium and magnesium phosphate in the urine, which is then incorporated into the biofilm, resulting in encapsulation of the catheter (= incrustations). Incrustations are often seen with prolonged catheterization.

Healthcare-acquired infections are common as a complication of hospitalization and among nursing home residents. In Denmark, since 2008 national prevalence surveys have been performed twice a year. UTI is one of the most common infections of all registered healthcare sector-acquired infections and makes up between a quarter and a third. During the period, the number of patients with hospital-acquired UTI (HAUTI) who also had bladder catheters decreased from 66.7% to 21.2%. This favourable development can be attributed to the efforts made against HAUTI with a focus on partly reducing the use of bladder catheters, and partly on the design of guidelines and control programs in the field. Catheter-related UTI prevention is possible when catheters are used for a shorter time. For prolonged use, bacteriuria can not be prevented. Here the task is to prevent the bacteriuria from giving symptomatic infection. Gad et al made a systematic review and one of their conclusions was the lack of consensus in terminology. The terms Urinary tract infection, bacteriuria and catheter-associated urinary tract infection were loosely used and varied between the studies. Some studies have not even defined the criteria for their used outcome. Some studies used the terms CAUTI and catheter-associated asymptomatic bacteriuria or catheter-associated bacteriuria interchangeably. Additionally, terms like Bacteriuria and UTI were differently defined. The lack of consistency makes it very difficult to talk about the prevalence or incidence of CAUTI. The prevalence (2019) surveys correspond that 15-20,000 patients receive annually HAUTI in Danish hospitals. Recent prevalence surveys and foreign studies show that 15-25% of inpatients are catheterized during admission. Up to 80% of HAUTIs are associated with catheterization of the urinary tract. This is particularly true of the use of transurethral bladder catheters. Catheter-related UTIs lead to increased morbidity and mortality, prolonged hospitalization and higher costs. Pannek describes the safety of using the Uro-Tainer® Polihexanide for catheter irrigation in a safety study from 2020. Andersen found in 2020 that Uro-Tainer® Polihexanide has the potential to reduce catheter-associated complications such as CAUTI, improve quality of life and reduce healthcare costs. There is a strong rationale for ongoing catheter maintenance to prevent complications and maximize catheter life along with patient comfort and quality of life. Although catheter flushing with Uro-Tainer® with citric acid and Uro-Tainer® Polihexanide has been on the market for almost 10 years, no clinical studies are documenting the convincing effect.

Description of the cohort

Participants are included in the departments at the Odense University Hospital and from the municipalities. Inclusion Criteria Citizens not previously flushed  A permanent catheter (suprapubic and urethral)  Male and female > 18 years of age  Acute or previous catheter stop because of blocking or incrustations.  Voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study. Citizens previously flushed with NaCl or UroTainer  A permanent catheter (suprapubic and urethral)  Male and female > 18 years of age  Willingness to take a rinse break for a minimum of 4 weeks. In the event of 2 catheter stops during the flushing break, assessed on the basis of an urgent need for catheter flushing with NaCl or catheter change, the citizen can be included.  If there is no catheter stop during the rinsing break, the citizen will continue without rinsing until a possible catheter stop.  Voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study.

Data and biological material

We use: Demographic data Questionnaire data Data from the medical journal Catheter test and urine culture