Study of the Criteria for Choosing Speedicath Catheters During the Initiation of Self-catheterization
Eva
1 other identifier
observational
250
1 country
38
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2021
CompletedStudy Start
First participant enrolled
September 30, 2021
CompletedFirst Posted
Study publicly available on registry
October 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2023
CompletedMarch 11, 2022
March 1, 2022
1.3 years
August 10, 2021
March 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Patient questionnaire for the choice of the catheter
At baseline
Patient satisfaction
At visit 2 : 3 to 12 weeks
Patient satisfaction
At visit 3 : 6 months
"Intermittent Catheterization Difficulty Questionnaire" IC-Di-Q
At visit 2 : 3 to 12 weeks
"Intermittent Catheterization Difficulty Questionnaire" IC-Di-Q
At visit 3 : 6 months
- +3 more secondary outcomes
Study Arms (1)
Patients
Adult subjects with neurogenic or non-neurogenic urinary tract disorders, newly initiated to ASI, and users of the SpeediCath line of catheters.
Interventions
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
The study will be offered to all adult subjects with neurogenic or non-neurogenic urinary disorders, newly initiated to ISC, and using the SpeediCath line of catheters.
You may qualify if:
- 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
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gérard AMARENCO, Pr., MD
Hôpital Tenon
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2021
First Posted
October 4, 2021
Study Start
September 30, 2021
Primary Completion
January 30, 2023
Study Completion
January 30, 2023
Last Updated
March 11, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share