Define Final Selection Choice Criteria for a Coloplast Catheter Ensuring Highest Patient Satisfac… (NCT07355803) | Clinical Trial Compass
RecruitingNot Applicable
Define Final Selection Choice Criteria for a Coloplast Catheter Ensuring Highest Patient Satisfaction Via Surveys (EVA).
Belgium107 participantsStarted 2025-10-21
Plain-language summary
Understanding the Coloplast Intermittent Catheter Selection Study:
This study aims to understand how adults who need to use catheters to empty their bladder by themselves decide which Coloplast catheter works best for them. The two types of catheters studied are called SpeediCath and Luja.
Why is this study being done? The study wants to find out which catheter type helps people feel most satisfied when they start to use it on their own. It also looks at why people choose their catheter at the beginning, how happy they are with it over the first six months, and what problems they might face using it.
Who can join the study?
* Adults aged 18 or older who have bladder problems and need to empty their bladder using a catheter.
* People who have been trained on how to use a catheter.
* People who have chosen to use either SpeediCath or Luja catheters from Coloplast.
* People who can perform the catheterization themselves at least two times per day.
Certain people cannot join, such as pregnant women, anyone who cannot give consent, or those who have trouble filling out questionnaires.
What will happen in the study?
Participants will visit the study center three times:
* At the start (to select their catheter and answer questions about the reasons for the specific catheter selection)
* After 3 to 12 weeks (to share their perception on the impact of the used catheter)
* After 6 months (to measure final satisfaction and any difficulties)
If a participant changes to a different catheter type or catheter brand during the study, this will be recorded, and they will continue in the study.
How will this study help? The information gathered will help healthcare providers understand what matters most to people when selecting a catheter. This can improve how catheters are recommended and support patients better during self-catheterization and improve treatment adherence and compliance.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female or male aged eighteen years or older;
* Written informed consent;
* Subject affiliated with a social security scheme or beneficiary;
* Subject with neurogenic or non-neurogenic bladder issues, justifying the implementation of intermittent self-catheterisation (ISC) to clean out the bladder;
* Subject who received his/her initial ISC training at the time of inclusion;
* Subject for whom the expected ISC duration is at least six months;
* Subject for whom at least two types of Coloplast catheters have been introduced and who has chosen to use Coloplast catheters as the first catheter for self-catheterisation;
* Subject able to independently conduct ISC;
* Subject for whom the healthcare professional has recommended to conduct ISC at least four times per day.
Exclusion Criteria:
* Vulnerable subject with regard to the current regulation:
* Pregnant, parturient or breast-feeding woman;
* Subject deprived of freedom by judicial, medical or administrative decision;
* Underage subject;
* Subject is legally protected or unable to express his/her consent;
* Subject not affiliated with or not a beneficiary of a social security scheme;
* Subject falling into several categories above;
* Subject who refused to participate in the study;
* Subject participating in an interventional clinical study;
* Subject who, according to the investigator, has cognitive problems that prevent him/her from completing a questionnaire or for whom the assessment ma…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Self-Questionnaire responses on final criteria for Coloplast catheter selection associated with patient satisfaction.