Risk factors for urinary tract infections associated with lower quality of life among intermittent catheter users.
Marcio Augusto Averbeck, Michael Kennelly, Nikesh Thiruchelvam...
https://pubmed.ncbi.nlm.nih.gov/37830866Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07355803
EVA-study on Catheter Selection Criteria at Start of Self-catheterization
Led by Coloplast NV/SA · Updated on 2026-01-21
107
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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 catheter's 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).
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Female or male aged eighteen years or older
- Written informed consent
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Belgium
Actively Recruiting
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Research Team
F
François Hervé
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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Published Research Related To This Trial
Adult Neurogenic Lower Urinary Tract Dysfunction and Intermittent Catheterisation in a Community Setting: Risk Factors Model for Urinary Tract Infections.
Michael Kennelly, Nikesh Thiruchelvam, Márcio Augusto Averbeck...
https://pubmed.ncbi.nlm.nih.gov/31065264Intermittent catheterization acceptance test (I-CAT): A tool to evaluate the global acceptance to practice clean intermittent self-catheterization.
Amandine Guinet-Lacoste, Jacques Kerdraon, Alexandra Rousseau...
https://pubmed.ncbi.nlm.nih.gov/28090660A prospective, randomized, crossover, multicenter study comparing quality of life using compact versus standard catheters for intermittent self-catheterization.
Emmanuel Chartier-Kastler, Gérard Amarenco, Lena Lindbo...
https://pubmed.ncbi.nlm.nih.gov/23587630Intermittent catheterization: Clinical practice guidelines from Association Française d'Urologie (AFU), Groupe de Neuro-urologie de Langue Française (GENULF), Société Française de Médecine Physique et de Réadaptation (SOFMER) and Société Interdisciplinaire Francophone d'UroDynamique et de Pelvi-Périnéologie (SIFUD-PP).
X Gamé, V Phé, E Castel-Lacanal...
https://pubmed.ncbi.nlm.nih.gov/32220571Hydrophilic-coated catheters for intermittent catheterisation reduce urethral micro trauma: a prospective, randomised, participant-blinded, crossover study of three different types of catheters.
J Stensballe, D Looms, P N Nielsen...
https://pubmed.ncbi.nlm.nih.gov/16126331[Urinary tract infection and neurogenic bladder].
J Salomon, A Gory, L Bernard...
https://pubmed.ncbi.nlm.nih.gov/17622075Prevention and management of urosepsis triggered by ureteroscopy.
Kymora B Scotland, Dirk Lange
https://pubmed.ncbi.nlm.nih.gov/30013956Assessment of Intermittent Self-Catheterization Procedures in Patients with Neurogenic Lower Urinary Tract Dysfunction: Dutch Translation and Validation of the Intermittent Catheterization Satisfaction Questionnaire, Intermittent Catheterization Acceptance Test, Intermittent Self Catheterization Questionnaire and Intermittent Catheterization Difficulty Questionnaire.
François Hervé, Inge Ragolle, Gérard Amarenco...
https://pubmed.ncbi.nlm.nih.gov/30999304Intermittent catheterization difficulty questionnaire (ICDQ): A new tool for the evaluation of patient difficulties with clean intermittent self-catheterization.
Amandine Guinet-Lacoste, Marylène Jousse, Eliane Tan...
https://pubmed.ncbi.nlm.nih.gov/25327888