Study on Choosing Coloplast Catheters for Adults Using Self-Catheterization to Improve Satisfaction
Led by Coloplast NV/SA · Updated on 2026-01-21
107
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying how adults with bladder problems who need to empty their bladder using catheters decide which Coloplast catheter best suits them. The study focuses on two types of catheters, SpeediCath and Luja, aiming to understand which catheter leads to the highest patient satisfaction over six months. It also explores the reasons behind initial catheter choice, satisfaction levels during use, and any challenges faced. The study includes adults with neurogenic or non-neurogenic bladder dysfunctions, such as those caused by spinal cord injuries or multiple sclerosis, who have been trained in intermittent self-catheterisation ISC.
Participants will use either SpeediCath or Luja catheters, which differ in design and technology to improve ease of use and reduce complications. The study involves three visits at the start to choose a catheter and record reasons for this choice between 3 and 12 weeks to assess the catheters impact and at six months to evaluate final satisfaction and any difficulties. If participants change their catheter type or brand during the study, this will be documented, and they will continue in the study. Questionnaires on catheter use, satisfaction, and difficulties will be used to collect data.
Participants will attend three study visits over six months, completing questionnaires about catheter choice, satisfaction, and challenges experienced during ISC. Researchers will collect information on socio-demographics, clinical factors, catheter use frequency, and training details. The main outcome is patient satisfaction with the chosen catheter at six months, along with adherence to ISC protocols and difficulties encountered. This information aims to help healthcare providers improve catheter recommendations and support for patients using self-catheterisation.
CONDITIONS
Brief Title
Define Final Selection Choice Criteria for a Coloplast Catheter Ensuring Highest Patient Satisfaction Via Surveys (EVA).
Research Team
F
François Hervé
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Affiliated with a social security scheme or beneficiary
Diagnosed with neurogenic or non-neurogenic bladder issues requiring intermittent self-catheterisation (ISC)
Received initial ISC training at time of inclusion
Expected ISC use for at least six months
Introduced to at least two types of Coloplast catheters and chosen Coloplast as first catheter
Able to perform ISC independently
Recommended by healthcare professional to perform ISC at least four times per day
You will not qualify if you...
Pregnant, parturient, or breastfeeding women
Individuals deprived of freedom by judicial, medical, or administrative decision
Underage individuals
Those legally protected or unable to give consent
Not affiliated with or beneficiary of a social security scheme
Individuals who refused to participate
Participants in another interventional clinical study
Those with cognitive problems preventing questionnaire completion or assessment
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants begin intermittent self-catheterisation training and select a Coloplast catheter. They complete questionnaires on catheter use, satisfaction, and challenges.
3 visits: inclusion visit, visit between 3 and 12 weeks, and visit at 6 months
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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