Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT05065255 Statut inconnu

Titre

Study of the Criteria for Choosing Speedicath Catheters During the Initiation of Self-catheterization (Eva)

Type

Observational

Pathologie

Rétention d'urine

Phase

Promoteur

Laboratoires Coloplast S.A.S (Voir sur ClinicalTrials)

Date de début

septembre 2021

Date de fin

janvier 2023

Dernière mise à jour

29 juin 2024

Résumé

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.

Détail

Voir le détail 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. It is important that the patient is involved in his or her choice of equipment, since the decision to self-catheterize is usually made by the physician, and that the benefits of self-catheterization outweigh the constraints. The patient must be guided and involved in the choice of catheter during this learning phase, which will ensure better compliance and future adherence to treatment. The interest of this study is therefore to better understand the real motivations of the patient in the choice of the catheter. This will undoubtedly make it possible to improve either the equipment itself or certain FTE sequences in the future by insisting on the problematic or questioning points in terms of the choice of catheter proposed to the patient by the caregiver. The determinants of the patient's choice are all the more important as there are a very large number of catheters on the market. Coloplast offers the SpeediCath® (SC) range of ready-to-use self-lubricating hydrophilic catheters. This range is designed to cover the different needs of patients, providing them with probes of different length, flexibility, shape and ergonomics. There are 3 types of catheters adapted to women (SC Standard®, SC Compact® and SC Compact Set, SC Compact Eve®), and 3 types of catheters adapted to men (SC Standard®, SC Compact® and SC Compact Set, SC Flex®). Concerning the technical specificities, a systematic review of the literature concluded that hydrophilic catheters (with a lubricant attached to the catheter) provide a benefit in terms of safety and quality of life, particularly in patients with spinal cord injuries. SC® catheters significantly reduce trauma to the urinary tract by reducing friction. Another study also showed that SpeediCath catheters were significantly faster, more convenient, and more discreet to use than a non-ready-to-use hydrophilic catheter (need to activate lubricant). The superiority of SpeediCath Compact Male and Female catheters in terms of quality of life compared to reference catheters was demonstrated in a randomized study using the specific validated ISC-Q questionnaire and has been retained and valued by the CNEDiMTS To date, there is no objective data to help in the choice of the type of catheter to propose to the patient according to his needs. Although it is now known that the quality of life of patients using ISC is dependent on multiple factors, there is little data on the factors that facilitate or hinder adherence to ISC during the first six months after initiation of ISC. The prospective multicenter exploratory observational study that the sponsor wishes to conduct aims to determine the criteria that govern patient choice of 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 ISC, with ISC education occurring at the time of inclusion. Patients should be autonomous in the practice of ISC, and the minimum expected duration of follow-up should be greater than or equal to 6 months. Only patients who have chosen to use SpeediCath leads will be included in the study. Numerous criteria will be collected to allow a detailed analysis of the modalities of choice of the type of SC probe. This collection involves the use of self-questionnaires for the patients. These questionnaires will be collected during the usual follow-up of the patient, including a visit at the time of the ASI education, a follow-up visit around 3 to 12 weeks (depending on the practices of the investigating center) and a second follow-up visit around 6 months. Acceptance of ISC will be measured by the Intermittent Catheterization Acceptance Test (I-CAT). This is a patient questionnaire developed by the Groupe d'Études de Neuro-Urologie de Langue Française (GENULF) and validated in French in 2016 during a prospective multicenter study of 201 neurological and non-neurological patients. The I-CAT allows for a better assessment and understanding of the psychological barriers encountered by patients in relation to ISC. The questionnaire consists of 14 questions, with a minimum score of 0 for perfect acceptance and a maximum score of 56 characterizing the least possible acceptance. The difficulties encountered by patients during ASI will be measured by the "Intermittent Catheterization Difficulty Questionnaire" IC-Di-Q. This is a patient questionnaire validated in French, and its purpose is to evaluate the difficulties encountered during the performance of ISA. In 13 questions, it explores numerous factors such as pain, blockage, bleeding, spasticity, and urethral sphincter spasm, in terms of frequency of occurrence and intensity. The purpose of this questionnaire is to identify the difficulties encountered by patients, and to monitor their evolution after the implementation of alternatives or solutions (including the adaptation of the type of catheter). Patient adherence to ISC will be measured by the Intermittent Catheterization Adherence Scale (I-CAS). This is a patient questionnaire validated in French with 8 questions, 7 of which have a binary answer (yes/no), and one with 5 suggested answers. The score ranges from 0 for strong adherence to ISC to 8 for very weak adherence. A study-specific self-questionnaire was also created with the support of the Scientific Advisory Board to determine the reasons for the patient's choice of catheter. This questionnaire includes criteria independent of the patient (e.g. advice from the nurse), and criteria specific to the patient (e.g. ease of use, discretion). Fermer le détail

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Tenon	Gérard Amarenco	Recrutement non commencé	Contact (sur clinicalTrials)
C.H. ROBERT BALLANGER	Emmanuel Van Glabeke	Recrutement non commencé	Contact (sur clinicalTrials)
CENTRE HOSPITALIER DE GONESSE	Mohamed Marouane Hmida	Recrutement non commencé	Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre auterive - Auterive - France	Sophie Rouleaud	En recrutement	Contact (sur clinicalTrials)
Centre Calvé- Fondation Hopale - Berck - France	Jean Gabriel Prévinaire	Recrutement non commencé	Contact (sur clinicalTrials)
Centre de l'Arche - Saint-Saturnin - France	Gaelle Audat	Recrutement non commencé	Contact (sur clinicalTrials)
Centre Hospitalier William Morey - Chalon-sur-Saône - France	Nicolas Koutlidis	Recrutement non commencé	Contact (sur clinicalTrials)
Centre médical Germaine Revel - Chamalières - France	Vivien Reynaud	Recrutement non commencé	Contact (sur clinicalTrials)
Centre PSR - Perpignan - France	Redha Benbouzid	Recrutement non commencé	Contact (sur clinicalTrials)
CHU de Caen - Caen - France	Antoine Desvergée	Recrutement non commencé	Contact (sur clinicalTrials)
CHU de Nancy - Nancy - France	Pierre Lecoanet	En recrutement	Contact (sur clinicalTrials)
CHU de Timonnes - Marsillargues - France	Camino Muro Guerra	Recrutement non commencé	Contact (sur clinicalTrials)
CHU GrenobleAlpes - La Tronche - France	Caroline Thuillier	Recrutement non commencé	Contact (sur clinicalTrials)
CHU Le Bocage - Dijon - France	Céline Duperron	En recrutement	Contact (sur clinicalTrials)
CHU Limoges - Limoges - France	Aurelien Descazeaud	Recrutement non commencé	Contact (sur clinicalTrials)
CHU Reims - Reims - France	Richard Seret	Recrutement non commencé	Contact (sur clinicalTrials)
CHU Rennes - Rennes - France	Benoit Peyronnet	Recrutement non commencé	Contact (sur clinicalTrials)
CHU Rouen - Rouen - France	Jean-Nicolas CORNU	Recrutement non commencé	Contact (sur clinicalTrials)
CHU Toulouse Rangueil - Toulouse - France	Xavier Game	En recrutement	Contact (sur clinicalTrials)
CHU Tours - Tours - France	Franck Bruyère	Recrutement non commencé	Contact (sur clinicalTrials)
Clinique Saint Martin - Marseille - France	Karine Lenne Aurier	Recrutement non commencé	Contact (sur clinicalTrials)
CMMRF Kerpape - Ploemeur - France	Jacques Kerdraon	Recrutement non commencé	Contact (sur clinicalTrials)
Hôpital Bellevue, CHU de SAINT ETIENNE - Saint-Étienne - France	Julia Touly	Recrutement non commencé	Contact (sur clinicalTrials)
Hopital Charles Nicolle - Rouen - France	Maximilien Baron	Recrutement non commencé	Contact (sur clinicalTrials)
Hôpital Henry Gabrielle - Saint Genis Laval - France	Amandine Guinet-Lacoste	En recrutement	Contact (sur clinicalTrials)
Hôpital Henry Gabrielle - Saint-Genis-Laval - France	Damien Waz	Recrutement non commencé	Contact (sur clinicalTrials)
Hôpital Lapeyronie - Montpellier - France	Laurent Cabaniols	Recrutement non commencé	Contact (sur clinicalTrials)
Hôpital Pasteur 2 - CHU de Nice - Nice - France	Imad Bentellis	Recrutement non commencé	Contact (sur clinicalTrials)
Hôpital Raymond Poincaré - Garches - France	Alexia Even	Recrutement non commencé	Contact (sur clinicalTrials)
Hôpital Saint jacques - Nantes - France	Bénédicte Reiss	En recrutement	Contact (sur clinicalTrials)
Hôpital Swynghedauw - Lille - France	Anne Blanchard	Recrutement non commencé	Contact (sur clinicalTrials)
Hôpital Universitaire Pitié-Salpêtrière - Paris - France	Emmanuel Chartier-Kastler	Recrutement non commencé	Contact (sur clinicalTrials)
Hôpital Victor Provo - Roubaix - France	François Pecoux	Recrutement non commencé	Contact (sur clinicalTrials)
Hôpitaux civil de Colmar - Colmar - France	Amine Messaoudi	Recrutement non commencé	Contact (sur clinicalTrials)
Institut Mutualiste Montpelliérain- Beau soleil - Montpellier - France	Grégoire Poinas	Recrutement non commencé	Contact (sur clinicalTrials)
Nouvel Hôpital Civil - Strasbourg - France	Thibault Tricard	Recrutement non commencé	Contact (sur clinicalTrials)
Tour de Gassies - Bruges - France	Amandine Grelier	Recrutement non commencé	Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria:

- 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

Critère de non inclusion

- 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.

NCT05065255 - Study of the Criteria for Choosing Speedicath Catheters During the Initiation of Self-catheterization (Eva)

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Etablissements
Critères
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