CP382 - Intermittent Catheter (IC) PRO Panel Plan

NCT07475468 | Not Yet Recruiting

• 1 other identifier: CP382
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intermittent Catheterization

Outcome Measures

Primary Outcomes (3)

• 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.

  5 years

• The number of urinary tract infections

  Frequency and consequences of urinary tract infections.

  5 years

• 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".

  5 years

Interventions

No Intervention: Observational Cohort OTHER

There is only one observational cohort.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Willing to give informed consent
• 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

Sponsors & Collaborators

• Coloplast A/S: lead
• IQVIA Pty Ltd: collaborator

Related Publications (4)

• 4) FDA, Center for Devices and Radiological Health: Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory Decisions (subsection IB, pages 50-55), March 2021, Link: https://www.fda.gov/media/146258/download)

  BACKGROUND

• Biardeau X, Corcos J. Intermittent catheterization in neurologic patients: Update on genitourinary tract infection and urethral trauma. Ann Phys Rehabil Med. 2016 Apr;59(2):125-9. doi: 10.1016/j.rehab.2016.02.006. Epub 2016 Apr 1.

  PMID: 27053002 BACKGROUND

• Fumincelli L, Mazzo A, Martins JCA, Henriques FMD, Orlandin L. Quality of life of patients using intermittent urinary catheterization. Rev Lat Am Enfermagem. 2017 Jul 10;25:e2906. doi: 10.1590/1518-8345.1816.2906.

  PMID: 28699993 BACKGROUND

• Scruggs-Wodkowski E, Kidder I, Meddings J, Patel PK. Urinary Catheter-Associated Infections. Infect Dis Clin North Am. 2024 Dec;38(4):713-729. doi: 10.1016/j.idc.2024.07.006. Epub 2024 Sep 10.

  PMID: 39261137 BACKGROUND

Related Links

• Related Info

Study Officials

• Ann-Sophie Luel-Brockdorff, PhD

  Coloplast A/S

  STUDY DIRECTOR

Central Study Contacts

Carri Browne. Clinical Project Manager, BS

CONTACT

6123235772; dkcarr@coloplast.com

Ann-Sophie luel-Brockdorff, Sr. Clinical Strategy Project Manager, PhD

CONTACT

+45 49112078; dkasib@coloplast.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 16, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 30, 2032
• Study Completion (Estimated): October 31, 2032
• Last Updated: May 13, 2026

Record last verified: 2026-05