Indwelling catheter patient experiences and the potential usability and acceptance of the T‐Control® prototype urinary catheter

Abstract

The aim of this study was to analyse the experience of users of indwelling bladder catheters and evaluate the anticipated usability of a prototype of the T‐Control® urinary catheter (without being inserted) by patients who were able to compare the differences between the T‐Control® prototype and other urinary catheters and urinary catheter accessories. A qualitative study was conducted with people who had lived with an indwelling urinary catheter for at least 1 week. Two user‐centred design techniques were applied: patient experience trajectory map and Think Aloud, a method where the participants were able to express their previous experiences, expectations and preferences while manipulating the devices. The experiential trajectory was collected based on a semi‐structured following interviews. Participants were able to manipulate the new T‐Control® and, based on their previous experiences, compare the potential usability of T‐control® with Foley‐type catheter and its accessories All the participants stated that they had experienced negative emotions concerning bladder catheterisation during the trajectory of use, from the initial prescription and adaptation to the follow‐up, and the forced life changes that a permanent catheterisation implies. The most frequent emotions were rejection and sadness. The new T‐Control® device could potentially improve the patient experience, as all participants perceived advantages related to the closure system, ease of use, safety and discretion. Participants also noted its closure system as an advantage and highlighted its ease of use, although one‐handed operation required some learning. Catheters currently on the market are functional, but some patients do not always have a satisfactory experience. This might negatively affect their quality of life, so there is a wide market opportunity for new devices that improve clinical and psychological care. Based on patient evaluation, the new T‐Control® device with a built‐in valve could provide benefits for patients.

A study protocol of a comparative mixed study of the T‐Control catheter

“… Catheter‐related quality of life questionnaire: To evaluate the specific health‐related quality of life for long‐term catheterized patients, Rethink Medical has developed two specific instruments created in the context of this project based on the experience of our previous studies (Patient's workshop). 25 The first one (Data S5 ), administered during the initial visit, consists of 47 questions, related to the patient's experience and journey with catheterization before the study, as baseline data. The questions are related to the type of catheter and accessories used, the experience of catheterization, emotions felt at the beginning (right from the moment of the prescription), satisfaction and comfort with the catheter, complications associated with catheter use, usability and complications associated with accessories and changes in the personal habits caused by the catheter's use, and how these issues have affected their lives.…”

“… 24 Furthermore, patients' experience in the use of bladder catheters were comparatively evaluated with T‐Control and conventional catheters and recognized the added value and the intuitive and ease of use of T‐Control. 25 Finally, in vitro studies have observed how T‐Control significantly prevented/delayed the formation and growth of biofilm during the first 5 days, compared with conventional Foley‐type catheter. 26 In addition, another pilot clinical study is currently being carried out with the T‐Control catheter in patients with acute urinary retention (NCT05643950), for which the first results are expected to be obtained at the end of the first quarter of 2024.…”

Effectiveness of the T‐Control catheter: A study protocol

“…• Catheter-related QoL questionnaire: To evaluate the specific HRQoL for patients with AUR, Rethink Medical has developed a specific instrument created in the context of this project based on the experience of our previous studies (Patient's workshop). 25 The questionnaire consists of 29 questions, related to the patient's experience and journey. These questions are related to the emotions felt at the beginning (right from the moment of the prescription), and during the catheter's usage, the acceptability and usability of the catheter itself and the accessories required (collection bag, plugs or others), personal satisfaction, adverse events and changes in the personal habits caused by the catheter's…”

“…24 Furthermore, patients experienced in the use of bladder catheters, comparatively evaluated T-Control with conventional catheters and recognised the added value and the intuitive and ease of use of T-Control. 25 Finally, in in vitro studies have been observed how T-Control significantly prevented/delayed the formation and growth of biofilm during the first 5 days, compared with conventional Foley-type catheter. 26 This clinical trial protocol shares the methodology to make progress in regard to the process of generating evidence on the effectiveness, safety and cost-effectiveness of T-Control, to improve clinical and self-perceived health outcomes by patients, compared to conventional catheters currently used.…”