Health TrialsbyHealthPanel

CP382 - Intermittent Catheter (IC) PRO Panel Plan

ConditionIntermittent Catheterization
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorColoplast A/S

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willing to give informed consent

18 years of age or above

Full legal capacity

Willing and able (self-assessed) to complete online questionnaires

Disqualifiers

None

Trial population

Individuals using intermittent catheterization as their primary bladder emptying method will be invited to participate. The initial aim of the registry is to include 1000 users following 18 months after launching the registry in all countries.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • No Intervention: Observational Cohort

    Other intervention

    There is only one observational cohort.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Number of IC products used by subjects.

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.

Time frame
5 years
2

The number of urinary tract infections

Frequency and consequences of urinary tract infections.

Time frame
5 years
3

The Mental well-being index (WHO-5)

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".

Time frame
5 years

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Coloplast A/S

Lead sponsor

IQVIA Pty Ltd

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: