An observational study in Intermittent Catheterization, sponsored by Coloplast A/S. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Coloplast A/S · Observational
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.
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.
Coloplast A/S is the lead sponsor of 150 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
There is only one observational cohort.
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
The number of urinary tract infections
Frequency and consequences of urinary tract infections.
Time frame: 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".
Time frame: 5 years
No study locations are listed for this record.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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