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NCT05065255: Eva

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

Status unknown Last updated 11 March 2022
What this trial tests

trial testing SpeediCath® catheters in Urinary Retention in 250 participants. Status unknown.

Timeline
30 September 2021
Primary endpoint
30 January 2023
30 January 2023

Quick facts

Lead sponsorLaboratoires Coloplast S.A.S
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment250
Start date30 September 2021
Primary completion30 January 2023
Estimated completion30 January 2023
Sites38 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Laboratoires Coloplast S.A.S

Who can join

18 and older, any sex, with Urinary Retention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Urinary Retention

Currently open trials in the same condition.

Other Laboratoires Coloplast S.A.S trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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