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 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT04290403
Eligibility Criteria:
Inclusion Criteria:
* Able to toilet independently or independently following prompting or instruction to do so.
* Independently mobile, with or without walking aids
* Use of any type of continence produce, for the management of moderate incontinence.
* Moderate incontinence severity as measured by Incontinence Severity (Sandvik) index.
* Availability of care partner willing to co-operate and participate in trail procedures
Exclusion Criteria:
* Need for daily help with dexterity to apply any continence product
* Waist size or body shape which renders any size of either investigational product inapplicable
* PLWD unable to indicate the need to toilet
* PLWD with significant faecal incontinence
* Permanent residence in nursing home or expected to enter nursing home within two months of trail entry
* Presence of any other condition, which, in the opinion of the investigator makes PLWD unable to participate in the necessary trail procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT04290403
Study Brief:
Protocol Section:
NCT04290403