Comparative Mixed Study of the Foley Catheter With the T-Control® Catheter in Patients With Long-term Catheterization
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Catheter-Associated Urinary Tract Infection
- Sponsor
- Rethink Medical SL
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Self-perceived general health status using 5 dimensions of 5 levels each, and a VAS ranging from 0 to 100.
- Status
- Suspended
- Last Updated
- 11 months ago
Overview
Brief Summary
This is a comparative, randomized, controlled pilot study. The main objective of this study is to evaluate the efficacy, comfort, and patient experience in people with long-term bladder catheterization with T-Control® versus patients with a conventional Foley-type catheter.
Detailed Description
This is a mixed study, in which, on the one hand, a pilot, randomized, two-arm comparative study will be carried out to compare the T-Control® catheter versus the Foley-type catheter in patients with long-term catheterization, monitoring the patient from the insertion of the catheter until its removal or change (4 weeks). On the other hand, a study will be carried out with qualitative methodology, through discussion groups to explore the experience of the patients who participated in the part of the study with quantitative methodology. The sample of patients will be recruited in the urology service of Hospital 12 de Octubre. The identification of patients eligible to participate will be carried out by members of the urology service staff. During the inclusion period, all those patients who require a long-term bladder catheter change will be invited to participate, who will be interviewed at an initial visit, where the inclusion and exclusion criteria will be checked, the patients will receive information about the study, they will decide whether or not they want to participate, they will sign and deliver the written informed consent and they will be randomly included in the study in one of the two arms, study group (patients catheterized with T-Control®) and control group (patients catheterized with conventional Foley). Both inclusion and randomization will be performed by the investigator responsible for catheter insertion. During this initial visit, patients who decide to participate and meet the criteria will receive an incident diary to keep and record follow-up, and the catheter will be inserted. Four weeks after bladder catheter insertion, patients will be called for a follow-up visit, during which the study catheter will be removed or replaced. If the patient is selected for the discussion group, during this follow-up visit they will be informed of the date and place where the qualitative study will be carried out. The discussion groups will be moderated by a researcher with experience in this field who does not have a therapeutic relationship with the participants.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Man or women equal or over 18 years old
- •Patients who require a change of bladder catheter.
- •Indication of bladder catheterization for 4 weeks.
- •Maintained cognitive and physical capacity for self-monitoring of the T-Control ® catheter valve.
- •Agree to participate in the study and sign the informed consent.
Exclusion Criteria
- •Symptoms of infection at the time of inclusion in the study.
- •Use of current antibiotic treatment or in the 2 weeks prior to inclusion in the study.
- •Patients with malformations in the urinary tract
- •Immunocompromised patients, diagnosed with cancer or AIDS.
- •Urological cancer patients
- •Patients who require continuous urine drainage (in the case of patients in the study arm) or hourly urine output measurement.
- •Catheter insertion requiring more than one attempt.
- •Inability to read and understand Spanish
Outcomes
Primary Outcomes
Self-perceived general health status using 5 dimensions of 5 levels each, and a VAS ranging from 0 to 100.
Time Frame: Day 28 after inclusion
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.
Patient experience for both types of catheterization
Time Frame: Through study completion, an average of 9 months
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.
Quantitively assessed self-perceived catheter-related experience
Time Frame: Day 28 after inclusion
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.
Secondary Outcomes
- Number of adverse events related to catheterization(Day 28 after inclusion)
- Catheter tip-positive culture rate(Day 28 after inclusion)
- Indication of antibiotic treatments(Day 28 after inclusion)
- Total costs of each type of catheterization (cost-effectiveness) per quality-adjusted life year (QALY) of catheterized participants(Through study completion, an average of 9 months)
- Rate and magnitude of infections (symptomatic and asymptomatic)(Day 28 after inclusion)
- Opinion of healthcare professionals of the devices used during the study(Through study completion, an average of 9 months)
- The workload perceived by health professionals participating in the study.(Through study completion, an average of 9 months)