Comparative Study Between Foley and T-Control® Catheter in Patients With Long-term Catheterization

Patient experience for both types of catheterization

For data collection, the technique of discussion groups will be used using a semi-structured script, which will serve for the identification of preferences and needs in daily life and for training and information for the use of the devices of catheterised patients. The discussion groups will be audio-recorded, transcribed and moderated by a researcher with experience in this field who does not have a therapeutic relationship with the participants.

Self-perceived general health status using 5 dimensions of 5 levels each, and a VAS ranging from 0 to 100.

The following instrument is administered to participants: EuroQol-5 Dimensions-5 Levels. A questionnaire that measures the patient's health status from a physical, psychological and social point of view. It consists of the descriptive system EQ-5D, which comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels ranging from no problems to extreme problems. This decision results in a 1-digit number for each dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. In addition, it also features the EQ Visual Analogue Scale (EQ VAS), which records the patient's self-rated health on a visual analogue scale, where the endpoints are labelled "The best health you can imagine" (100) and "The worst health you can imagine" (0). The VAS can be used as a quantitative measure of health outcomes that reflect the patient's own judgement.

Quantitively assessed self-perceived catheter-related experience

Rethink Medical developed a specific instrument created in the context of this project based on the experience of our previous studies. The questionnaire aims to assess the self-perceived quality of life of catheterised patients and includes 29 questions that collect data on the prescription of the bladder catheter and on the accessories used (collection bag, cap or others), questions related to acceptability, usability and satisfaction in relation to the catheter and the accessories used, adverse events and changes in habits associated with the catheterisation and emotions perceived at the beginning and during the use of the bladder catheter. In order to quantitatively assess the answers, the statements will include multiple answer options, single options and answers with scores on a scale of 1 to 10.

Rate and magnitude of infections (symptomatic and asymptomatic)

The number of urinary tract infections will be obtained from the analysis of urine samples taken from patients. The research staff will take two samples from each patient, one at the time of inclusion in the study and another at the follow-up visit, four weeks after the insertion of the probe, coinciding with the change of the catheter. The presence of pathogenic microorganisms in quantities greater than or equal to 1,000 CFU/ml will determine the presence of infection, while, in the absence of symptoms of infection, a determination of microorganisms greater than or equal to 100,000 CFU/ml will indicate asymptomatic infection.

Catheter tip-positive culture rate

A 1 cm catheter between the fixation balloon of the bladder catheter will be sectioned in a sterile manner, sent in a sterile container to the microbiology laboratory to analyze and identify the type of microorganisms.

Number of adverse events related to catheterization

The type and number of adverse events will be recorded: accidental disconnection of the catheter, obstruction, pain, loss of urine per catheter, haematuria and accidental spills caused by the professional during the moment of insertion.

Indication of antibiotic treatments

The antibiotic that has been administered associated with the use of the catheter will be recorded.