Effectiveness of the T-Control catheter: A study protocol.

Autor: Ramallo-Fariña Y; Evaluation Unit (SESCS), Canary Island Health Service Canary Islands Health Research Institute Foundation (FIISC) Tenerife Spain.; Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS) Tenerife Spain., Chávarri AT; Evaluation Unit (SESCS), Canary Island Health Service Canary Islands Health Research Institute Foundation (FIISC) Tenerife Spain.; Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS) Tenerife Spain., Robayna AA; Department of Urology University Hospital of Nuestra Señora de Candelaria Tenerife Spain., Vidal MM; Rethink Medical SL Gran Canaria Spain., Valcárcel-Nazco C; Evaluation Unit (SESCS), Canary Island Health Service Canary Islands Health Research Institute Foundation (FIISC) Tenerife Spain.; Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS) Tenerife Spain., Armas Moreno C; Rethink Medical SL Gran Canaria Spain., Perestelo-Pérez L; Evaluation Unit (SESCS), Canary Island Health Service Canary Islands Health Research Institute Foundation (FIISC) Tenerife Spain.; Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS) Tenerife Spain., Serrano Muñoz M; Rethink Medical SL Gran Canaria Spain., Luque González M; Rethink Medical SL Gran Canaria Spain., García-Pérez L; Evaluation Unit (SESCS), Canary Island Health Service Canary Islands Health Research Institute Foundation (FIISC) Tenerife Spain.; Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS) Tenerife Spain., García-Bello MÁ; Evaluation Unit (SESCS), Canary Island Health Service Canary Islands Health Research Institute Foundation (FIISC) Tenerife Spain.; Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS) Tenerife Spain.; University of La Laguna (ULL) Tenerife Spain., Serrano-Aguilar P; Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS) Tenerife Spain., Castellano Santana PR; University of La Laguna (ULL) Tenerife Spain., Vera Álamo L; Department of Urology Insular University Hospital of Gran Canaria Gran Canaria Spain.
Jazyk: angličtina
Zdroj: BJUI compass [BJUI Compass] 2023 Dec 04; Vol. 5 (2), pp. 178-188. Date of Electronic Publication: 2023 Dec 04 (Print Publication: 2024).
DOI: 10.1002/bco2.285
Abstrakt: Background: Foley catheters have been subject to limited development in the last few decades. They fulfil their basic function of draining urine from the bladder but cause other associated problems. T-Control is a new silicone Foley catheter with an integrated fluid control valve whose design aims to reduce the risks associated with bladder catheterisation by a multifactorial approach. The general purpose of this study is to evaluate the effectiveness and cost-effectiveness of the T-Control catheter versus the Foley-type catheter in patients with Acute Urine Retention (AUR).
Study Design: This is a pragmatic, open, multicentre, controlled clinical trial with random allocation to the T-Control catheter or a conventional Foley-type catheter in patients with AUR.
Endpoints: The magnitude of infections will be analysed as a primary endpoint. While as secondary endpoint, the following will be analysed: rate of symptomatic and asymptomatic infections; days free of infection; quality of life-related to self-perceived health; indication of associated antibiotic treatments; determination of biofilm; number of catheter-related adverse events; use of each type of catheterisation's healthcare resources; level of satisfaction and workload of health professionals and acceptability of the T-Control device as well as the patient experience.
Patients and Methods: Eligible patients are male adults aged ≥50 years, with AUR and with an indication of bladder catheterisation for at least 2 weeks. The estimated sample size is 50 patients. Patient follow-up includes both the time of catheter insertion and its removal or change 2 weeks later, plus 2 weeks after this time when the patient will be called for an in-depth interview.
Competing Interests: This group of authors (YRF, ATC, CVN, LPP, LGP, MAGB and PSA) belongs to the Evaluation Unit (SESCS), Canary Island Health Service (SCS) (www.sescs.es), an institution of the Canary Islands Government that is also a member of the Spanish Network for Research on Chronicity, Primary Care and Health Promotion (RICAPPS, www.ricapps.es). This article is part of the early dialogues activity carried out by the SESCS as an Evaluation agency and declares that they have no competing interests. ML, MS, CA and MM are part of Rethink Medical S.L., which is the sponsor of this study, owning the rights of T‐Control. LV, AA and PRC declare that they have no competing interests.
(© 2023 ReThink Medical SL and The Authors. BJUI Compass published by John Wiley & Sons Ltd on behalf of BJU International Company.)
Databáze: MEDLINE
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