Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07355803
Eligibility Criteria:
Inclusion Criteria:
* Female or male aged eighteen years or older;
* Written informed consent;
* Subject affiliated with a social security scheme or beneficiary;
* Subject with neurogenic or non-neurogenic bladder issues, justifying the implementation of intermittent self-catheterisation (ISC) to clean out the bladder;
* Subject who received his/her initial ISC training at the time of inclusion;
* Subject for whom the expected ISC duration is at least six months;
* Subject for whom at least two types of Coloplast catheters have been introduced and who has chosen to use Coloplast catheters as the first catheter for self-catheterisation;
* Subject able to independently conduct ISC;
* Subject for whom the healthcare professional has recommended to conduct ISC at least four times per day.
Exclusion Criteria:
* Vulnerable subject with regard to the current regulation:
* Pregnant, parturient or breast-feeding woman;
* Subject deprived of freedom by judicial, medical or administrative decision;
* Underage subject;
* Subject is legally protected or unable to express his/her consent;
* Subject not affiliated with or not a beneficiary of a social security scheme;
* Subject falling into several categories above;
* Subject who refused to participate in the study;
* Subject participating in an interventional clinical study;
* Subject who, according to the investigator, has cognitive problems that prevent him/her from completing a questionnaire or for whom the assessment may be a problem.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07355803
Study Brief:
Protocol Section:
NCT07355803