Evidence behind T-Control®

Patient and user experience

• 2024Indwelling catheter patient experiences and the potential usability and acceptance of the T-Control® prototype urinary catheterPatient Experience Study – International Journal of Urological Nursing (IJUN)This study explores the experiences of people living with an indwelling urinary catheter and the emotional and practical dimensions associated with its use. Participants were also introduced to and handled a T-Control® prototype, providing feedback on perceived usability, ease of handling and potential acceptance. It offers useful insight into urinary catheterisation from the patient perspective.View publication →
• 2023Estudio descriptivo sobre el estado actual del manejo urinario en pacientes con lesión medular y valoración de la nueva sonda T-Control®Descriptive Study – ENFURO JournalThis descriptive study examines challenges associated with urinary management in people with spinal cord injury and explores their perceptions of available options. Participants were also introduced to the T-Control® concept and provided feedback on its potential usefulness and usability. The findings reflect participant perceptions and expectations, not clinical efficacy outcomes for the device.View publication →

Preclinical (in vitro)

• 2024Comparative study of in vitro biofilm formation with the innovative T-Control® catheterIn-vitro Study – ENFURO JournalThis comparative in-vitro study examines bacterial colonisation and biofilm formation on T-Control® versus a conventional Foley catheter under the experimental conditions evaluated. The results showed lower biofilm formation on T-Control® in this laboratory model, providing preclinical evidence to support further investigation of this aspect of the design.In vitro laboratory study. In vitro biofilm results are not predictive of clinical infection outcomes.View publication →

Healthcare professional surveys

• 2023Practices Related to Bladder Catheterisation Among Swedish Health Professionals: A Questionnaire SurveyHealthcare Professional Survey – International Journal of Urological Nursing (IJUN)This questionnaire survey explores practices, difficulties and challenges related to urinary catheterisation among Swedish healthcare professionals. The findings provide context on issues such as procedural demands, maintaining technique and difficulties that may arise during catheterisation, helping to identify unmet needs in urinary catheter management.View publication →
• 2024Prácticas relacionadas con el sondaje vesical: una encuesta a profesionales de la salud españolesHealthcare Professional Survey – ENFURO JournalThis questionnaire survey examines the experience of Spanish healthcare professionals during urinary catheterisation and the difficulties encountered in routine practice. Issues such as maintaining technique, handling the system and accidental exposure to urine help identify ongoing challenges in the procedure and areas where innovation may address unmet needs.View publication →

Simulation and usability

• 2023Evaluating possible improvements in indwelling urinary catheter insertion from nurses' point of view: A pilot comparative study of simulated insertion between the novel T-Control® and a Foley-type catheterSimulation Study – International Journal of Urological Nursing (IJUN)In this pilot simulation study, nurses with previous catheterisation experience compared the insertion procedure using T-Control® and conventional Foley systems. Participants assessed aspects related to handling, usability and preference in the simulated setting, providing useful information on the healthcare professional experience during the procedure.View publication →
• 2024Comparative simulated insertion between T-Control® and Foley-type catheter in nursing students with no prior trainingSimulation Study – ScienceDirectThis simulation study evaluated the use of T-Control® and a conventional Foley catheter by nursing students with no previous urinary catheterisation training. Participants assessed ease of use and selected functional characteristics of T-Control®, providing information on usability in a controlled learning environment.View publication →
• 2024Comparative study of bladder catheterisation using the Foley-type catheter and the T-Control® catheter: a simulation study.Comparative Study – ENFURO JournalThis simulation study compared urinary catheterisation with T-Control® and a conventional Foley catheter in final-year nursing students with previous experience. In the simulated setting, participants assessed aspects such as satisfaction, handling, procedural control and maintenance of technique, providing additional information about device usability.View publication →

Functional evaluation

• 2023T-Control®. A new leak-tight urethral catheterFunctional Evaluation – ENFURO JournalThis study evaluates a functional characteristic of T-Control® related to system leak-tightness. The tests provide information on device behaviour with respect to unintended ingress and egress of fluids under the conditions evaluated, helping to characterise this aspect of its design and function.View publication →

Clinical and health economics

T-Control® has been evaluated in clinical settings, including studies conducted with the University Hospital 12 de Octubre in Madrid and usability research with midwives at Artevelde Academy in Belgium. An economic model developed with Syreon Research Institute explores the potential financial impact of T-Control® under modelled assumptions and was accepted for presentation at the XLIV AES Health Economics Conference.

• 2025Economic model of the potential financial impact of the T-Control catheter under modelled assumptionsCongress Abstract – XLIV AES Health Economics ConferenceCongress abstract. Not peer-reviewed in full-text form.View publication →