Study of the Criteria for Choosing Speedicath Catheters During the Initiation of Self-catheterization
NCT ID: NCT05065255
Last Updated: 2022-03-11
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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UNKNOWN
250 participants
OBSERVATIONAL
2021-09-30
2023-01-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients
Adult subjects with neurogenic or non-neurogenic urinary tract disorders, newly initiated to ASI, and users of the SpeediCath line of catheters.
SpeediCath® catheters
Patients using SC catheters will be followed up in order to understand the major criteria in the choice of the catheter by the patients.
Interventions
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SpeediCath® catheters
Patients using SC catheters will be followed up in order to understand the major criteria in the choice of the catheter by the patients.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Laboratoires Coloplast S.A.S
INDUSTRY
Responsible Party
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Principal Investigators
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Gérard AMARENCO, Pr., MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Tenon
Locations
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Centre hospitalier d'Aulnay sous bois
Aulnay-sous-Bois, , France
Centre Hospitalier Intercommunal Robert Ballanger
Aulnay-sous-Bois, , France
Centre auterive
Auterive, , France
Centre Calvé- Fondation Hopale
Berck, , France
Tour de Gassies
Bruges, , France
CHU de Caen
Caen, , France
Centre Hospitalier William Morey
Chalon-sur-Saône, , France
Centre médical Germaine Revel
Chamalières, , France
Hôpitaux civil de Colmar
Colmar, , France
CHU Le Bocage
Dijon, , France
Hôpital Raymond Poincaré
Garches, , France
Centre Hospitalier de Gonesse
Gonesse, , France
CHU GrenobleAlpes
La Tronche, , France
Hôpital Swynghedauw
Lille, , France
CHU Limoges
Limoges, , France
Clinique Saint Martin
Marseille, , France
CHU de Timonnes
Marsillargues, , France
Hôpital Lapeyronie
Montpellier, , France
Institut Mutualiste Montpelliérain- Beau soleil
Montpellier, , France
CHU de Nancy
Nancy, , France
Hôpital Saint jacques
Nantes, , France
Hôpital Pasteur 2 - CHU de Nice
Nice, , France
Hôpital Tenon
Paris, , France
Hôpital Universitaire Pitié-Salpêtrière
Paris, , France
Centre PSR
Perpignan, , France
CMMRF Kerpape
Ploemeur, , France
CHU Reims
Reims, , France
CHU Rennes
Rennes, , France
Hôpital Victor Provo
Roubaix, , France
CHU Rouen
Rouen, , France
Hopital Charles Nicolle
Rouen, , France
Hôpital Bellevue, CHU de SAINT ETIENNE
Saint-Etienne, , France
Hôpital Henry Gabrielle
Saint-Genis-Laval, , France
Hôpital Henry Gabrielle
Saint-Genis-Laval, , France
Centre de l'Arche
Saint-Saturnin, , France
Nouvel Hôpital Civil
Strasbourg, , France
CHU Toulouse Rangueil
Toulouse, , France
CHU Tours
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Béatrice Davenne
Role: primary
Emmanuel Van Glabeke
Role: primary
Sophie Rouleaud
Role: primary
Jean Gabriel Prévinaire
Role: primary
Amandine Grelier
Role: primary
Antoine Desvergée
Role: primary
Nicolas Koutlidis
Role: primary
Vivien Reynaud
Role: primary
Amine Messaoudi
Role: primary
Céline Duperron
Role: primary
Alexia Even
Role: primary
Mohamed Marouane Hmida
Role: primary
Caroline Thuillier
Role: primary
Anne Blanchard
Role: primary
Aurelien Descazeaud
Role: primary
Karine Lenne Aurier
Role: primary
Camino Muro Guerra
Role: primary
Laurent Cabaniols
Role: primary
Grégoire Poinas
Role: primary
Pierre Lecoanet
Role: primary
Bénédicte Reiss
Role: primary
Imad Bentellis
Role: primary
Gérard Amarenco
Role: primary
Emmanuel Chartier-Kastler
Role: primary
Redha Benbouzid
Role: primary
Jacques Kerdraon
Role: primary
Richard Seret
Role: primary
Benoit Peyronnet
Role: primary
François Pecoux
Role: primary
Jean-Nicolas CORNU
Role: primary
Maximilien Baron
Role: primary
Julia Touly
Role: primary
Amandine Guinet-Lacoste
Role: primary
Damien Waz
Role: primary
Gaelle Audat
Role: primary
Thibault Tricard
Role: primary
Xavier Game
Role: primary
Franck Bruyère
Role: primary
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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2021-A00579-32
Identifier Type: -
Identifier Source: org_study_id
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