RecruitingNot ApplicableNCT07355803

Define Final Selection Choice Criteria for a Coloplast Catheter Ensuring Highest Patient Satisfaction Via Surveys (EVA).

EVA-study on Catheter Selection Criteria at Start of Self-catheterization

Sponsor

Coloplast NV/SA

Enrollment

107 participants

Start Date

Oct 21, 2025

Study Type

INTERVENTIONAL

Conditions

Urinary Retention Bladder Dysfunction Neurogenic Bladder Disorder Non-Neurogenic Bladder

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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 Criteria10

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 may be a problem.

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Interventions

OTHERQuestionnaires : Patient questionnaire on catheter use and satisfaction, IC-Di-Q, and I-CAT

The 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.