Evidence map›Paper›PMID 38371205›Full record

ArticleBJUI compass2024

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

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 and 4 more

Open access · goldAbstract read
In one paragraph

Article in BJUI compass, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 5 institutions in 1 country.

Yolanda Ramallo-FariñaEvaluation Unit (SESCS), Canary Island Health Service Canary Islands Health Research Institute Foundation (FIISC) Tenerife Spain.
Ana Toledo ChávarriEvaluation Unit (SESCS), Canary Island Health Service Canary Islands Health Research Institute Foundation (FIISC) Tenerife Spain.
Adrián Amador RobaynaDepartment of Urology University Hospital of Nuestra Señora de Candelaria Tenerife Spain.
Max Mòdol VidalRethink Medical SL Gran Canaria Spain.
Cristina Valcárcel-NazcoEvaluation Unit (SESCS), Canary Island Health Service Canary Islands Health Research Institute Foundation (FIISC) Tenerife Spain.
Clara Armas MorenoRethink Medical SL Gran Canaria Spain.
Lilisbeth Perestelo-PérezEvaluation Unit (SESCS), Canary Island Health Service Canary Islands Health Research Institute Foundation (FIISC) Tenerife Spain.
Marta Serrano MuñozRethink Medical SL Gran Canaria Spain.
Manuel Luque GonzálezRethink Medical SL Gran Canaria Spain.ORCID https://orcid.org/0000-0002-3764-119X
Lidia García-PérezEvaluation Unit (SESCS), Canary Island Health Service Canary Islands Health Research Institute Foundation (FIISC) Tenerife Spain.
Miguel Ángel García-BelloEvaluation Unit (SESCS), Canary Island Health Service Canary Islands Health Research Institute Foundation (FIISC) Tenerife Spain.
Pedro Serrano-AguilarNetwork for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS) Tenerife Spain.
Pedro Raúl Castellano SantanaUniversity of La Laguna (ULL) Tenerife Spain.ORCID https://orcid.org/0000-0003-4122-3545
Laura Vera ÁlamoDepartment of Urology Insular University Hospital of Gran Canaria Gran Canaria Spain.
Red de Investigación en Actividades Preventivas y Promoción de la Salud · ESGran Telescopio Canarias (Spain) · ESUniversidad de La Laguna · ESHospital Universitario Insular de Gran Canaria · ESHospital Universitario Nuestra Señora de Candelaria · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

acute urine retentioncatheterisationcost‐effectivenessFoleyquality of lifestudy protocolT‐Controlurinary tract infection

Identifiers

PMID38371205
PMCPMC10869656
OpenAlexW4389343377

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.