CP382 - Intermittent Catheter (IC) PRO Panel Plan
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Intervention: Observational Cohort.
- Who it may be relevant to
- Registry conditions: Intermittent Catheterization. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other No Intervention: Observational Cohort
There is only one observational cohort.
Primary outcome measures
- Number of IC products used by subjects. [Time frame: 5 years]
- The number of urinary tract infections [Time frame: 5 years]
- The Mental well-being index (WHO-5) [Time frame: 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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)
- 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
- 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
- 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
Identifiers
NCT: NCT07475468 · CP382