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:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT04924569
Eligibility Criteria:
Inclusion Criteria:
1. Is at least 18 years of age; male or female.
2. Is performing transurethral intermittent catheterization.
3. Uses intermittent catheter(s) from any manufacturer as a form of management for urinary retention or incomplete bladder emptying.
4. Must be able to provide informed consent and have no cognitive impairment that would hinder the ability to provide informed consent or self-reported data.
5. Lives and has permanent residence in one of the countries that the study is being conducted at time of enrollment (USA, Canada, UK, Germany, France, The Netherlands, or Italy)
6. Is willing and able to complete electronic questionnaires monthly for the first year of data collection and quarterly thereafter or appoint a caregiver proxy.
7. Is able to read and respond to the questionnaires in the language options provided for a given country (e.g. French Canadian or English for Canada)
Exclusion Criteria:
1. Performs non transurethral catheterization, e.g., stoma.
2. Participating in a clinical study involving transurethral intermittent self-catheterization at the time of enrollment.
3. Employee of Sponsor at the time of enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04924569
Study Brief:
Protocol Section:
NCT04924569