CP382 - Intermittent Catheter (IC) PRO Panel Plan
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Coloplast A/S
- Enrollment
- 1,000
- Primary Endpoint
- Number of IC products used by subjects.
Study Overview
Brief Summary
The aim is to create an electronic patient reported outcome (e-PRO) based registry, specifically for subjects using an intermittent catheter as their primary bladder emptying method.
Detailed Description
The registry's objective is to allow for insights into the needs of people with intimate healthcare needs from the user's perspective and experience. The registry will provide valuable information from the participants' perspective on several issues including, but not limited to product use and satisfaction, frequency of urinary tract infections, and quality-of-life related to IC use. The registry will allow for a more user-centric approach when listening and responding to the needs and challenges of IC users.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Willing to give informed consent
- •18 years of age or above
- •Full legal capacity
- •Willing and able (self-assessed) to complete online questionnaires
- •using intermittent catheterization as the primary method for bladder emptying
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of IC products used by subjects.
Time Frame: 5 years
Characterization of a cohort of IC users at point-of-entry to the registry including but not limited to, IC product consumption, user-patterns, prescriptions, and use of supporting products.
The number of urinary tract infections
Time Frame: 5 years
Frequency and consequences of urinary tract infections.
The Mental well-being index (WHO-5)
Time Frame: 5 years
Quality-of-life (QoL) using the Mental well-being index (WHO-5). The subject has 5 questions asked, with 6 different responses available: "All of the time", "Most of the time", "More than half the time", "less than half the time", "some of the time", and "at no time". The choice of "all of the time" equates to a better well-being than a response of "at no time".
Secondary Outcomes
No secondary outcomes reported