Urinary Retention Clinical Trial
— EvaOfficial title:
Study of the Criteria for Choosing Speedicath Catheters During the Initiation of Self-catheterization
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.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | January 30, 2023 |
Est. primary completion date | January 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
France | 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 Henry Gabrielle | Saint Genis Laval | |
France | Hôpital Bellevue, CHU de SAINT ETIENNE | Saint-Étienne | |
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 |
Lead Sponsor | Collaborator |
---|---|
Laboratoires Coloplast S.A.S |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient questionnaire for the choice of the catheter | 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). | At visit 3 : 6 months | |
Secondary | Patient questionnaire for the choice of the catheter | 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). | At baseline | |
Secondary | Patient satisfaction | Determined by a 0 to 5 points visual analog scale, 0 is the worst possible satisfaction, and 5 is the best possible satisfaction | At visit 2 : 3 to 12 weeks | |
Secondary | Patient satisfaction | Determined by a 0 to 5 points visual analog scale, 0 is the worst possible satisfaction, and 5 is the best possible satisfaction | At visit 3 : 6 months | |
Secondary | "Intermittent Catheterization Difficulty Questionnaire" IC-Di-Q | This is a patient questionnaire validated in French.The purpose of this questionnaire is to identify the difficulties encountered by the patients and to follow their evolution after the implementation of alternatives or solutions (including the adaptation of the type of catheter). 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. | At visit 2 : 3 to 12 weeks | |
Secondary | "Intermittent Catheterization Difficulty Questionnaire" IC-Di-Q | This is a patient questionnaire validated in French.The purpose of this questionnaire is to identify the difficulties encountered by the patients and to follow their evolution after the implementation of alternatives or solutions (including the adaptation of the type of catheter). 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. | At visit 3 : 6 months | |
Secondary | Catheterization Adherence Scale (I-CAS) | This is a patient questionnaire validated in French with 8 questions, 7 of which have a binary response (yes/no), and one with 5 suggested answers. The score ranges from 0 for strong adherence to ASI to 8 for very weak adherence. | At visit 2 : 3 to 12 weeks | |
Secondary | Catheterization Adherence Scale (I-CAS) | This is a patient questionnaire validated in French with 8 questions, 7 of which have a binary response (yes/no), and one with 5 suggested answers. The score ranges from 0 for strong adherence to ASI to 8 for very weak adherence. | At visit 3 : 6 months | |
Secondary | Intermittent Catheterization Acceptance Test (I-CAT) questionnaire | The I-CAT allows for a better assessment and understanding of the psychological barriers encountered by patients in relation to ISA. 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. | At baseline |
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