What Are the Criteria for the Patient's Choice of Sel-catheterization Catheter
NCT ID: NCT04033913
Last Updated: 2019-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
73 participants
OBSERVATIONAL
2018-11-12
2019-09-30
Brief Summary
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Detailed Description
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The arrival of hydrophilic catheters has revolutionized management, reducing the risk of traumatic and infectious complications and facilitating their use. Many catheters are now available, and the choice of catheter may depend on different factors: grip disorder, ease of use, design and packaging, discomfort or pain when testing a specific material, specific anatomical conditions (male Tiemann or olive tip), longer catheter length in case of imperfect emptying, explanations given on how to use the catheter... Thus, if the doctor and the nurse involved in the patient's therapeutic education in self-catheterization will guide the choice of the catheter according to medical criteria and the patient's physical capacities, the patient remains an active participant in the choice of the model. Making the patient an actor and decision-maker can also improve adherence to treatment.
The aim of this study is to evaluate which are the most important criteria guiding the choice of the catheter for the patient.
In this study, the investigators develop a questionnaire based on expert meetings and literature review of the criteria that guide the choice of the catheter.
Five areas are explored: catheter design, catheter length, comfort of using the catheter, nurse's explanations, easy to transport and dispose of the catheter.
The importance of each criterion is rated by a 4-level likert scale (strongly disagree, somewhat disagree, somewhat agree, strongly agree) and patient have to report the most important criterion for the choice of the catheter.
Number of types of catheter showed and tried are reported, and if they chose the first, second, are two types of catheter. The questionnaire is completed at the end of a day hospital to learn to perform CISC
Data collected are:
* Age
* Sex
* Etiology of urinary disorders
* Score of the Pencil and Paper Test
* Functional Independence Measure score
* Nine Hold Peg Test over 18
* "Tinetti Mobility Test" score
* sensory hand problems assessed by Weber test
Statistical analyses will be performed with the R software for Windows (Rx64 3.2.3, R Foundation for Statistical Computing, Vienna, Austria). Descriptive data will be presented as means with standard deviation for continuous data and as medians with range for ordinal data and data not normally distributed.
Differences between the choosing criterion and the patients' characteristics will be assessed using analysis of variance or Chi2 tests. A p value of less than 0.05 will be considered statistically significant.
This study was approved by the local ethics review board.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adult patient learning self-catheterization
Patients who have successfully perform self-catheterization during a day hospital in a neuro-urology department complete a questionnaire validated by experts on the different criteria that guided the final choice of the catheter
Self questionnaire
Patients who have successfully perform self-catheterization complete a self questionnaire on the importance of each criterion in choosing the catheter they have made.
Interventions
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Self questionnaire
Patients who have successfully perform self-catheterization complete a self questionnaire on the importance of each criterion in choosing the catheter they have made.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* refusal to participate
18 Years
ALL
No
Sponsors
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Gérard Amarenco
OTHER
Responsible Party
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Gérard Amarenco
Head of Neuro-Urology department, Tenon Hospital
Principal Investigators
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Gérard Amarenco, PhD
Role: PRINCIPAL_INVESTIGATOR
Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, Paris, France
Locations
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department of Neuro-Urology, Hôpital Teno
Paris, , France
Countries
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Other Identifiers
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GRC-01 GREEN
Identifier Type: -
Identifier Source: org_study_id