This is the first clinical trial with T-Control®, a novel silicone Foley catheter with an integrated fluid control valve. Its design aims to reduce the risks and adverse effects associated with bladder catheterisation.
The general purpose of this study is to determine the effectiveness of T-Control® and the experience of the patient catheterised with T-Control® compared to the conventional Foley catheter, by evaluating patients with long-term catheterization. A full description of the study protocol is available and published (1).

This trial is a pilot mixed-method study comprising a two-arm, parallel-group, comparative design. It involves the random allocation to either the T-Control® catheter or the traditional Foley catheter in patients requiring long-term catheterization.
The first patient was recruited at the end of September 2023 in a highly specialized hospital of Spain. Eligible patients are male and female adults aged ≥ 18 years, who require a urinary catheter change. Patients were randomized either to the control group (conventional Foley catheter) or to the intervention group (T-Control® catheter), assigned 1:1 to one of the two trial arms of the study. The blinded allocation sequence is concealed by the use of a centralised computerised randomisation system. Due to the type of device, it has not been possible to blind the study arm for the participants and the research team involved, but the data and its analysis have been blinded.
The patient's participation lasts for 4 weeks, after which participants attend a follow-up visit during which the study catheter is removed. The comfort and acceptability of the T-Control® device (qualitative) and the quality of life related to self-perceived health (quantitative) are analyzed as primary endpoints. On one hand, the primary outcome for quality of life related to self-perceived health is obtained through the instruments EuroQol-5D-5L and a Catheter-related Quality of Life (QoL) questionnaire. The questionnaire is divided into five different domains, including 57 questions: initial self-perception (questions 1 to 9), impact on lifestyle (questions 10 to 22), usability of the catheter (questions 23 to 36), drainage system (questions 37 to 44), and post-study self-perception (questions 45 to 57). Both instruments are administered at patient inclusion (baseline data) and at the end of the patient’s study participation.
On the other hand, the primary outcome for the qualitative primary endpoint, namely the comfort and acceptability of the T-Control® device, will be assessed to identify any discrepancies or affinities that might exist. 
Secondary outcomes include: the magnitude of infection, obtained from the analysis of urine culture samples taken from patients at the time of catheter insertion and at the time of catheter withdrawal (sample taken with newly inserted device or through spontaneous micturition); the rate of symptomatic and asymptomatic infections and "infection-free days", determined by classifying the magnitude of infection according to criteria based on the EAU clinical guidelines; indications of antibiotic treatments associated with catheter use; determination of the analysis of the biofilm formed on the catheters and identification of the microorganisms present; the number of adverse events related to catheterization; healthcare resources utilized; and the level of satisfaction and workload perceived by healthcare professionals.

Fifteen subjects who met the inclusion and exclusion criteria were recruited and randomly assigned to receive either a conventional Foley-type catheter (n=7) or the new T-Control® catheter (n=8). The study recruitment is still ongoing; therefore, the results presented are preliminary. Results for outcomes that have not yet been collected or analyzed have not been included. 
Out of the 15 patients recruited, only eleven participants were included in the analysis of the quantitative primary outcome (6 in the conventional Foley-type catheter group and 5 in the T-Control® group). 
Participants in the T-Control® group rated their overall quality of life related to self-perceived health (on a scale from 0, indicating the worst quality of life, to 10, indicating the best quality of life) with a mean of 6.15 out of 10 (SD=3.34), while the score for the Foley group was 5.68 out of 10 (SD=1.31). This higher score in perceived quality of life for the T-Control® group is especially relevant in the domains of impact on lifestyle (mean=7.73; SD=3.12 vs. mean=6.75; SD=1.72), initial self-perception (mean=5.97; SD=3.36 vs. mean=5.02; SD=1.45), and current self-perception (mean=5.32; SD=3.84 vs. mean=4.98; SD=0.73). 
Analyzing the data separately for patients catheterized with T-Control® versus those catheterized with the Foley catheter and comparing the results from the initial visit to the end of the patient's participation in the study, practically no changes in overall quality of life were observed in patients who used the conventional Foley catheter (mean=5.30; SD=1.73 vs. mean=5.68; SD=1.31). In contrast, patients who used the T-Control® showed an improvement of more than 1.6 points in their quality of life score (mean=4.46; SD=0.56 vs. mean=6.15; SD=3.34). 
Patients randomized to the T-Control® group began the study with a significant impact of the catheter on their lifestyle (where a higher score in this section of quality of life implies a lower impact); however, the use of the catheter greatly reduced this impact (mean=4.89; SD=2.98 vs. mean=7.73; SD=3.12). Patients randomized to the Foley catheter had a minimal improvement in this area after 4 weeks (mean=6.35; SD=1.83 vs. mean=6.75; SD=1.72), remaining almost 1 point below that of the T-Control®.
It should also be noted that in the specific question in which patients rated their satisfaction with the catheter from 0 to 10 (0 being not at all satisfied and 10 being very satisfied), the patients who used T-Control® reported a significant increase in satisfaction with the device very noticeably (mean=4.60; SD=3.36 vs. mean=7.60; SD=4.34) compared to patients who were randomized to the conventional Foley-type catheter (mean=5.50; SD=2.81 vs. mean=6.50; SD=3.27). Patients catheterized with T-Control® showed greater satisfaction with the catheter, increasing the score by more than 1 point at 4 weeks.
No significant differences were observed in the rest of the domains of the questionnaire. Remarkably, no adverse effects have been reported in the intervention arm of the study.

The preliminary data suggest that T-Control® may be associated with an improved overall quality of life compared to patients with conventional Foley-type catheters. Specifically, T-Control® may have less impact on patients' lifestyle and may require fewer adaptations (questions 10 to 22 of the questionnaire, that is: modification of liquid consumption and the adaptation of everyday habits, such as leisure, work, transportation, etc., or limitations in routine physical, social activities, or responsibilities).
In addition, patients using T-Control® report greater satisfaction with their device compared to the conventional Foley catheter.

The preliminary results of the study indicate a positive trend in quality of life improvements that the new T-Control® device can offer to patients with long-term bladder catheterization. This trend is observed particularly evident in the reduced impact on lifestyle, greater satisfaction with the device and, also a slight improvement in self-perception related to having a urinary catheter.
However, final conclusions about the enhanced quality of life and the impact of T-Control® on other critical aspects of bladder catheterization, such as catheter-associated urinary tract infections (CAUTI), await the study's completion. This further analysis will be crucial to assess the full benefits of this innovative catheter. If the preliminary results shown are confirmed at the end of the study, this may facilitate the acceptance of T-Control®.

Medina-Polo J, Salamanca-Castro AB, Ramallo-Fariña Y, Mòdol-Vidal M, Valcárcel-Nazco C, Armas-Moreno C, Perestelo-Pérez L, García-Pérez L, García-Bello MÁ, Luque-González M, Serrano-Muñoz M, Pérez-García S. A study protocol of a comparative mixed study of the T-Control catheter. BJUI Compass. 2024 Jan 2;5(3):345-355. https://doi.org/10.1002/bco2.313