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

NCT07355803 | Recruiting

• 1 other identifier: EVA-Belgium
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Dysfunction; Urinary Retention; Neurogenic Bladder Disorder; Non-Neurogenic Bladder

Outcome Measures

Primary Outcomes (1)

• Self-Questionnaire responses on final criteria for Coloplast catheter selection associated with patient satisfaction.

  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 Outcomes (5)

• Self-Questionnaire responses on criteria for patient's initial Coloplast catheter selection choice.

  Day 0 (at inclusion visit).

• Five-Point scale scores for patient's satisfaction with Coloplast catheter.

  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).

  At 3 to 12 weeks AND at 6 months.

• Patient's final choice criteria for the catheter selection variables.

  At 6 months.

• Adherence rates to Intermittent Self-Catheterization (ISC) protocol.

  At 6 months.

Study Arms (1)

Coloplast

EXPERIMENTAL

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

Interventions

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

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.

Coloplast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coloplast NV/SA: lead

Study Sites (1)

UZ Leuven

Leuven, Belgium

RECRUITING

Related Publications (18)

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• Guinet-Lacoste A, Kerdraon J, Rousseau A, Gallien P, Previnaire JG, Perrouin-Verbe B, Amarenco G. Intermittent catheterization acceptance test (I-CAT): A tool to evaluate the global acceptance to practice clean intermittent self-catheterization. Neurourol Urodyn. 2017 Sep;36(7):1846-1854. doi: 10.1002/nau.23195. Epub 2017 Jan 16.

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• Chartier-Kastler E, Amarenco G, Lindbo L, Soljanik I, Andersen HL, Bagi P, Gjodsbol K, Domurath B. A prospective, randomized, crossover, multicenter study comparing quality of life using compact versus standard catheters for intermittent self-catheterization. J Urol. 2013 Sep;190(3):942-7. doi: 10.1016/j.juro.2013.04.026. Epub 2013 Apr 12.

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• Guinet-Lacoste A, Jousse M, Tan E, Caillebot M, Le Breton F, Amarenco G. Intermittent catheterization difficulty questionnaire (ICDQ): A new tool for the evaluation of patient difficulties with clean intermittent self-catheterization. Neurourol Urodyn. 2016 Jan;35(1):85-9. doi: 10.1002/nau.22686. Epub 2014 Oct 18.

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• Chartier-Kastler E, Denys P. Intermittent catheterization with hydrophilic catheters as a treatment of chronic neurogenic urinary retention. Neurourol Urodyn. 2011 Jan;30(1):21-31. doi: 10.1002/nau.20929. Epub 2010 Oct 6.

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MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Urinary Retention

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Study Officials

• Roger Houben, PhD MBA

  Coloplast A/S

  STUDY DIRECTOR

Central Study Contacts

François Hervé

CONTACT

+32(0)496 39 36; Francois.Herve@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: January 21, 2026
• Study Start: October 21, 2025
• Primary Completion (Estimated): October 28, 2026
• Study Completion (Estimated): October 28, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

BE (1)