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

NCT05065255 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2022-03-11

No results posted yet for this study

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.

Conditions

  • Urinary Retention

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Laboratoires Coloplast S.A.S

    lead INDUSTRY

Principal Investigators

  • Gérard AMARENCO, Pr., MD · Hôpital Tenon

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2023-01-30
Completion
2023-01-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05065255 on ClinicalTrials.gov