Study of the Criteria for Choosing Speedicath Catheters During the Initiation of Self-catheterization
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 37
- 主要终点
- Patient questionnaire for the choice of the catheter
研究概览
简要总结
To date, there is no objective data to help in the choice of the type of catheter to offer to the patient according to his or her needs. Although it is now known that the quality of life of patients practicing intermittent self catheterisation is dependent on multiple factors, there is little data on the factors that facilitate or hinder adherence to intermittent self catheterisation during the first six months after initiation of intermittent self catheterisation. The prospective multicenter exploratory observational study that the sponsor wishes to conduct aims to determine what criteria preside over patient choice of SpeedyCath (SC) leads. This information would allow us to set up a personalized advice with each patient in the future, with the aim of proposing the SC catheter best adapted to his needs. The study population will consist of adults with neurogenic or non-neurogenic urinary disorders that warrant the use of intermittent self catheterisation, with intermittent self catheterisation education occurring at the time of inclusion. Patients should be autonomous in the practice of intermittent self catheterisation, and the minimum expected duration of follow-up should be greater than or equal to 6 months. Only patients who choose to use SpeediCath leads will be included in the study.
详细描述
Urinary self-catheterization consists of emptying the bladder oneself by inserting a catheter into the urethra. It is the reference method in case of dysfunctions of the bladder emptying phase, in particular in case of complete urinary retention or complete or incomplete bladder emptying with sub bladder obstruction. Neurological pathologies such as spinal cord injury, multiple sclerosis, multisystematic atrophy, peripheral neuropathies, Parkinson's disease, and stroke, may be the cause of bladder disturbances. These disturbances may also be caused by pelvic denervations as a result of enlarged pelvic surgeries or radiotherapy for the treatment of gynecological, urological or digestive cancers.
The objective of the implementation of intermittent self-catheterization (ISC) is to reduce the morbidity related to bladder and bowel dysfunction and to improve the quality of life of patients by making them more autonomous.
It involves a rigorous learning phase for the patient and a phase of acceptance of this new mictional mode.
When ISC is indicated, training is provided to the patient to enable him/her to manage daily catheterization. The objectives of this training are to understand, perform, monitor and adapt self-care. This training, mainly provided by the nursing staff and/or a specialist physician, is usually provided during a hospitalization. After returning home, the patient continues to be monitored by the specialist physician and the nursing team to evaluate the mastery of the technique (possibly reviewing the gesture and ensuring the adequacy of the catheter), the patient's adaptation to the practice of ISC, his compliance with the associated rules (frequency and regularity of catheterization, volume of urine) and any complications. A first visit is usually made between 3 and 12 weeks, then a second one after 6 months of use.
However, this therapeutic patient education (TPE), even when carried out by trained personnel, is not necessarily sufficient for immediate acceptance and adherence to self-catheterization in the medium to long term.
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
- 否
入选标准
- •Female or male, 18 years of age or older
- •Subject having been informed of the study and having decided to participate (no opposition)
- •Subject affiliated to a social security system or entitled to it
- •Subject with neurogenic or non-neurogenic urinary disorders, justifying the use of the ISC to empty the bladder
- •Subjects who have received their first ISC education at the time of inclusion
- •Subject with an expected duration of ISC of at least 6 months
- •Subject has been presented with at least two types of SC catheters and has chosen to use the SpeediCath line of catheters as their first self-catheterization catheter
- •Able to perform ISC independently
- •Subjects who have been recommended by their healthcare professional to perform catheterization at least 4 times per day
排除标准
- •Vulnerable subject according to the regulations in force
- •Pregnant, parturient or nursing woman;
- •Subject deprived of liberty by judicial, medical or administrative decision;
- •Minor subject ;
- •Subject protected by law or unable to give consent
- •Subject who is not affiliated or not a beneficiary of a social security system;
- •Subject falling into several of the above categories;
- •Subject who has refused to participate in the study
- •Subject participating in an interventional clinical study
- •Subjects who, in the opinion of the investigator, have cognitive problems that prevent them from answering a questionnaire or for whom assessment could be problematic.
结局指标
主要结局
Patient questionnaire for the choice of the catheter
时间窗: At visit 3 : 6 months
A study-specific self-administered questionnaire was created with the support of the Scientific Advisory Board to determine the reasons for the patient's choice of catheter. This questionnaire contains 18 questions, including criteria independent of the patient (e.g. advice from the nurse), and criteria specific to the patient (e.g. ease of use, discretion).
次要结局
- Patient questionnaire for the choice of the catheter(At baseline)
- Catheterization Adherence Scale (I-CAS)(At visit 3 : 6 months)
- Patient satisfaction(At visit 3 : 6 months)
- "Intermittent Catheterization Difficulty Questionnaire" IC-Di-Q(At visit 3 : 6 months)
- Intermittent Catheterization Acceptance Test (I-CAT) questionnaire(At baseline)