Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07355803

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

Led by Coloplast NV/SA · Updated on 2026-01-21

107

Participants Needed

1

Research Sites

53 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Provided written informed consent
  • Affiliated with a social security scheme or beneficiary
  • Have neurogenic or non-neurogenic bladder issues requiring intermittent self-catheterisation
  • Received initial ISC training at the time of inclusion
  • Expected to use ISC for at least six months
  • Introduced to at least two types of Coloplast catheters and chose Coloplast as first catheter
  • Able to perform ISC independently
  • Recommended by healthcare professional to perform ISC at least four times per day
Not Eligible

You will not qualify if you...

  • Pregnant, parturient, or breastfeeding women
  • Individuals deprived of liberty by judicial, medical, or administrative decision
  • Underage individuals
  • Legally protected individuals or those unable to consent
  • Not affiliated with or beneficiary of a social security scheme
  • Individuals refusing to participate in the study
  • Participants in other interventional clinical studies
  • Individuals with cognitive problems preventing questionnaire completion or assessment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UZ Leuven

Leuven, Belgium

Actively Recruiting

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Research Team

F

François Hervé

CONTACT

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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