CP382 - Intermittent Catheter (IC) PRO Panel Plan (382 PRO Panel)

May 11, 2026 updated by: Coloplast A/S
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Carri Browne. Clinical Project Manager, BS
  • Phone Number: 6123235772
  • Email: dkcarr@coloplast.com

Study Contact Backup

  • Name: Ann-Sophie luel-Brockdorff, Sr. Clinical Strategy Project Manager, PhD
  • Phone Number: +45 49112078
  • Email: dkasib@coloplast.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years
The number of urinary tract infections
Time Frame: 5 years
Frequency and consequences of urinary tract infections.
5 years
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".
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coloplast A/S

Collaborators

IQVIA Pty Ltd

Investigators

  • Study Director: Ann-Sophie Luel-Brockdorff, PhD, Coloplast A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 30, 2032

Study Completion (Estimated)

October 31, 2032

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CP382

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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