department of Neuro-Urology, Hôpital Teno
Paris, 75020, France
NCT Number: NCT04033913
The aim of this study is to evaluate which are the most important criteria guiding the choice of the catheter for the patient to perform clean intermittent self catheterization.
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Notify Me18 year and older
All sexes
Observational
Paris, 75020, France
Management of voiding dysfunction has been revolutionized by the practice of clean intermittent self-catheterization (CISC) described by Lapides. It is nowadays the gold standard for the treatment of urinary retention in neurogenic bladders. But increasingly, CISC is prescribed to patients with non-neurogenic lower urinary tract symptoms (LUTS). Several studies have demonstrated an improvement in quality of life in patients under CISC. There are several indications for CISC in older adults, either in neurological condition (myelopathy following neck osteoarthritis, lumbar spinal stenosis, multiple sclerosis (MS), etc…) or not (bladder outlet obstruction, underactive detrusor, etc…).
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients who have successfully perform self-catheterization complete a self questionnaire on the importance of each criterion in choosing the catheter they have made.
Time frame: 1 day
patients must identify the most important criterion among the 5 proposed in the questionnaire created: catheter design; catheter length; comfort to handle the catheter; nurse's explanations; discretion for transport and disposal of the catheter.
Only one answer is accepted.
Time frame: 1 day
the importance of each criterion (catheter design; catheter length; comfort to handle the catheter; nurse's explanations; discretion for transport and disposal of the catheter) is rated by a 4-level likert scale (strongly disagree, somewhat disagree, somewhat agree, strongly agree)
Gérard Amarenco
Other
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