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临床试验/NCT04033913
NCT04033913已完成不适用

What Are the Criteria for the Patient's Choice of Sel-catheterization Catheter

Gérard Amarenco1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2018年11月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
73
试验地点
1
主要终点
The criterion of the created questionnaire for the choice of the catheter designated by the patient as the most important (rate of patients who identified each criterion as the most important)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults patients who have successfully perform self-catheterization during a day hospital in a neuro-urology department

排除标准

  • patient who does not speak French
  • refusal to participate

结局指标

主要结局

The criterion of the created questionnaire for the choice of the catheter designated by the patient as the most important (rate of patients who identified each criterion as the most important)

时间窗: 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.

次要结局

  • Importance for the choice of catheter of each of the 5 criteria of the questionnaire created, using a 4-level likert scale(1 day)

研究者

发起方
Gérard Amarenco
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gérard Amarenco

Head of Neuro-Urology department, Tenon Hospital

Pierre and Marie Curie University

研究点 (1)

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