Define Final Selection Choice Criteria for a Coloplast Catheter Ensuring Highest Patient Satisfaction Via Surveys (EVA).
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColoplast NV/SA
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Questionnaires : Patient questionnaire on catheter use and satisfaction, IC-Di-Q, and I-CAT
Other interventionThe study will be conducted in three visits (inclusion visit (V1), visit between 3 and 12 weeks (V2), visit at 6 months (V3)) during which investigators will collect data specific to the self-catheterization methods and to the use of catheters from the SpeediCath range or the Luja catheters, as well as a set of patient questionnaires. In the case of a catheter change during follow-up, the model and brand of the new catheter will be documented, and the participant will continue the study.
Treatment groups
107 Participants
are divided into 1 treatment groupGroup A: ColoplastExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Self-Questionnaire responses on final criteria for Coloplast catheter selection associated with patient satisfaction.
The primary objective of this study is to specify the final criteria for choosing the Coloplast catheter that provides patient satisfaction, as determined by self-questionnaire. Responses are scored ranging from 0 (strongly disagree) to 4 (strongly agree). Higher scores indicate a more positive attitude toward urinary self-catheterization.
Time frame
At 6 months.Secondary outcomes
1
Self-Questionnaire responses on criteria for patient's initial Coloplast catheter selection choice.
Responses are assessed using the self-questionnaire, which evaluates the importance of various factors influencing catheter choice (e.g., comfort, packaging, ease of use, hygiene). Items are rated on a 4-point scale from 1 = Not at all important to 4 = Very important, with higher scores indicating greater importance assigned to that factor.
Time frame
Day 0 (at inclusion visit).2
Five-Point scale scores for patient's satisfaction with Coloplast catheter.
Satisfaction and ease of learning are each rated on 5-point scales, where higher scores denote higher satisfaction or greater ease.
Time frame
At 3 to 12 weeks AND at 6 months.3
Intermittent Catheterization Difficulty Questionnaire (IC-Di-Q) questionnaire scores for challenges in Intermittent Self-Catheterization (ISC).
Responses are assessed with the Intermittent Catheterization Difficulty Questionnaire (IC-Di-Q), which evaluates the frequency and intensity of difficulties experienced during urinary self-catheterization over the past 15 days. Each item is rated on two 4-point scales: frequency (1 = Never to 4 = Always) and intensity (1 = None to 4 = Considerable). Higher scores indicate more frequent and/or more severe catheterization difficulties.
Time frame
At 3 to 12 weeks AND at 6 months.4
Patient's final choice criteria for the catheter selection variables.
Participants report the type of catheter most frequently used.
Time frame
At 6 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov