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

January 13, 2026 updated by: Coloplast NV/SA

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This multicentre prospective study examines the detailed clinical and technical aspects of intermittent self-catheterisation (ISC) training and catheter selection among adults with neurogenic or non-neurogenic bladder dysfunctions, such as those caused by spinal cord injuries, multiple sclerosis, Parkinson's disease, stroke, or pelvic surgeries.

Medical rationale :

ISC is the standard method for managing bladder emptying disorders, particularly in cases of urinary retention or incomplete voiding due to subvesical obstruction, aiming to reduce morbidity from vesico-sphincter dysfunctions and enhance patient independence. Training typically occurs during hospital admission by nursing staff or specialists, followed by outpatient monitoring at 3-12 weeks and 6 months to assess technique mastery, catheter suitability, compliance (frequency, volume), and complications. Despite expert training, long-term adherence remains challenging due to psychological barriers and equipment mismatches, underscoring the need for patient-involved catheter selection.

Technical catheter details :

Coloplast's SpeediCath® range includes hydrophilic, ready-to-use catheters differentiated by length, flexibility, shape, and ergonomics: Standard (40 cm men/20 cm women), Compact (no-touch for discretion), Compact Eve (triangular female design), Flex (multi-directional tip for men), with some available as pre-connected sets. Newer Luja™ catheters incorporate Micro-hole Zone Technology (>80 micro-holes in men, >50 in women) to minimise flow-stops, residual urine, and urinary tract infection (UTI) risk-addressing common issues where conventional eyelet catheters cause mucosa adhesion and incomplete emptying. Evidence shows hydrophilic catheters reduce urethral trauma and improve quality of life, with SpeediCath® demonstrating faster, more discreet use versus non-ready-to-use alternatives, and Luja/MHZC outperforming comparators in flow dynamics and user ratings. All are Class I sterile CE-marked devices manufactured by Coloplast A/S.

Study design and data collection This descriptive interventional cohort embeds questionnaire-based assessments into routine care across ~7 sites (urology/rehabilitation centres), targeting 107 patients for 6-month follow-up after a 6-month inclusion period. Beyond basic selection criteria, data capture socio-demographics (age, living status, education, occupation), clinical factors (pathology severity, USP symptom scores, anorectal dysfunction, meatus accessibility, urethral sensitivity, concomitant treatments), and ISC specifics (training location/duration, prescription frequency, solo vs. combined with micturition).

Validated tools include I-CAT (14 items, score 0-56 for ISC acceptance) and IC-Di-Q (13 items on pain, blockage, bleeding, spasticity frequency/intensity); a custom questionnaire details choice drivers (e.g., ease, discretion, nurse advice). Statistical plans use SAS V9.4 for descriptive stats, logistic regressions identifying predictors of final choice/adherence, with per-protocol exclusions for major deviations and precision ±4.25-9.5% for key frequencies. No blinding applies to this open-label routine care evaluation.

Study Type

Interventional

Enrollment (Estimated)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coloplast

The study population will consist of adults with neurogenic and non-neurogenic bladder issues, newly initiated at ISC, and users of Coloplast catheters.

The subject's participation in the study does not involve any additional examinations compared to the usual management of a patient. Only study questionnaires are used.

Patients are free to make the decision to change catheters during follow-up if the initially chosen catheter is not suitable for them. In this case, this change will be documented as well as the model and brand of the new catheter chosen, and the patient will continue the study normally.
Other: Questionnaires : 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Questionnaire responses on final criteria for Coloplast catheter selection associated with patient satisfaction.
Time Frame: At 6 months.
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.
At 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Questionnaire responses on criteria for patient's initial Coloplast catheter selection choice.
Time Frame: Day 0 (at inclusion visit).
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.
Day 0 (at inclusion visit).
Five-Point scale scores for patient's satisfaction with Coloplast catheter.
Time Frame: At 3 to 12 weeks AND at 6 months.
Satisfaction and ease of learning are each rated on 5-point scales, where higher scores denote higher satisfaction or greater ease.
At 3 to 12 weeks AND at 6 months.
Intermittent Catheterization Difficulty Questionnaire (IC-Di-Q) questionnaire scores for challenges in Intermittent Self-Catheterization (ISC).
Time Frame: At 3 to 12 weeks AND at 6 months.
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.
At 3 to 12 weeks AND at 6 months.
Patient's final choice criteria for the catheter selection variables.
Time Frame: At 6 months.
Participants report the type of catheter most frequently used.
At 6 months.
Adherence rates to Intermittent Self-Catheterization (ISC) protocol.
Time Frame: At 6 months.
Participants report their average daily catheterization frequency compared to the prescribed regimen; higher self-reported adherence indicates better compliance with the ISC protocol.
At 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coloplast NV/SA

Investigators

  • Study Director: Roger Houben, PhD MBA, Coloplast A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2025

Primary Completion (Estimated)

October 28, 2026

Study Completion (Estimated)

October 28, 2026

Study Registration Dates

First Submitted

December 5, 2025

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVA-Belgium

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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