Effectiveness of the T‐Control catheter: A study protocol
Abstract 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 desig...
| Main Authors: | , , , , , , , , , , , , , |
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| 格式: | 文件 |
| 语言: | English |
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Wiley
2024-02-01
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| 丛编: | BJUI Compass |
| 主题: | |
| 在线阅读: | https://doi.org/10.1002/bco2.285 |
| _version_ | 1827345863009107968 |
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| author | Yolanda Ramallo‐Fariña Ana Toledo Chávarri Adrián Amador Robayna Max Mòdol Vidal Cristina Valcárcel‐Nazco Clara Armas Moreno Lilisbeth Perestelo‐Pérez Marta Serrano Muñoz Manuel Luque González Lidia García‐Pérez Miguel Ángel García‐Bello Pedro Serrano‐Aguilar Pedro Raúl Castellano Santana Laura Vera Álamo |
| author_facet | Yolanda Ramallo‐Fariña Ana Toledo Chávarri Adrián Amador Robayna Max Mòdol Vidal Cristina Valcárcel‐Nazco Clara Armas Moreno Lilisbeth Perestelo‐Pérez Marta Serrano Muñoz Manuel Luque González Lidia García‐Pérez Miguel Ángel García‐Bello Pedro Serrano‐Aguilar Pedro Raúl Castellano Santana Laura Vera Álamo |
| author_sort | Yolanda Ramallo‐Fariña |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-03-07T23:19:50Z |
| format | Article |
| id | doaj.art-51e7eb2035c84f98bb6d88928579c260 |
| institution | Directory Open Access Journal |
| issn | 2688-4526 |
| language | English |
| last_indexed | 2024-03-07T23:19:50Z |
| publishDate | 2024-02-01 |
| publisher | Wiley |
| record_format | Article |
| series | BJUI Compass |
| spelling | doaj.art-51e7eb2035c84f98bb6d88928579c2602024-02-21T07:14:02ZengWileyBJUI Compass2688-45262024-02-015217818810.1002/bco2.285Effectiveness of the T‐Control catheter: A study protocolYolanda Ramallo‐Fariña0Ana Toledo Chávarri1Adrián Amador Robayna2Max Mòdol Vidal3Cristina Valcárcel‐Nazco4Clara Armas Moreno5Lilisbeth Perestelo‐Pérez6Marta Serrano Muñoz7Manuel Luque González8Lidia García‐Pérez9Miguel Ángel García‐Bello10Pedro Serrano‐Aguilar11Pedro Raúl Castellano Santana12Laura Vera Álamo13Evaluation Unit (SESCS), Canary Island Health Service Canary Islands Health Research Institute Foundation (FIISC) Tenerife SpainEvaluation Unit (SESCS), Canary Island Health Service Canary Islands Health Research Institute Foundation (FIISC) Tenerife SpainDepartment of Urology University Hospital of Nuestra Señora de Candelaria Tenerife SpainRethink Medical SL Gran Canaria SpainEvaluation Unit (SESCS), Canary Island Health Service Canary Islands Health Research Institute Foundation (FIISC) Tenerife SpainRethink Medical SL Gran Canaria SpainEvaluation Unit (SESCS), Canary Island Health Service Canary Islands Health Research Institute Foundation (FIISC) Tenerife SpainRethink Medical SL Gran Canaria SpainRethink Medical SL Gran Canaria SpainEvaluation Unit (SESCS), Canary Island Health Service Canary Islands Health Research Institute Foundation (FIISC) Tenerife SpainEvaluation Unit (SESCS), Canary Island Health Service Canary Islands Health Research Institute Foundation (FIISC) Tenerife SpainNetwork for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS) Tenerife SpainUniversity of La Laguna (ULL) Tenerife SpainDepartment of Urology Insular University Hospital of Gran Canaria Gran Canaria SpainAbstract 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.https://doi.org/10.1002/bco2.285acute urine retentioncatheterisationcost‐effectivenessFoleyquality of lifestudy protocol |
| spellingShingle | Yolanda Ramallo‐Fariña Ana Toledo Chávarri Adrián Amador Robayna Max Mòdol Vidal Cristina Valcárcel‐Nazco Clara Armas Moreno Lilisbeth Perestelo‐Pérez Marta Serrano Muñoz Manuel Luque González Lidia García‐Pérez Miguel Ángel García‐Bello Pedro Serrano‐Aguilar Pedro Raúl Castellano Santana Laura Vera Álamo Effectiveness of the T‐Control catheter: A study protocol BJUI Compass acute urine retention catheterisation cost‐effectiveness Foley quality of life study protocol |
| title | Effectiveness of the T‐Control catheter: A study protocol |
| title_full | Effectiveness of the T‐Control catheter: A study protocol |
| title_fullStr | Effectiveness of the T‐Control catheter: A study protocol |
| title_full_unstemmed | Effectiveness of the T‐Control catheter: A study protocol |
| title_short | Effectiveness of the T‐Control catheter: A study protocol |
| title_sort | effectiveness of the t control catheter a study protocol |
| topic | acute urine retention catheterisation cost‐effectiveness Foley quality of life study protocol |
| url | https://doi.org/10.1002/bco2.285 |
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