Choosing the Coloplast catheter that gives the highest patient satisfaction: SpeediCath versus Luja

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

This project will test whether adults who self-catheterize are more satisfied using Coloplast's SpeediCath or Luja catheters over their first six months of use.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 107 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Coloplast NV/SA (Industry-sponsored)
• Locations: 1 site (Leuven)
• Trial ID: NCT07355803 on ClinicalTrials.gov

What this trial studies

This multicentre prospective study follows adults with neurogenic or non-neurogenic bladder dysfunction who have been trained to perform intermittent self-catheterisation and who have selected Coloplast SpeediCath or Luja catheters. Participants complete standardized questionnaires (including IC-Di-Q and I-CAT) and report satisfaction, reasons for initial choice, adherence and complications at baseline, around 3–12 weeks, and at six months. The study compares patient-reported satisfaction and practical problems between catheter types to inform selection criteria. Data collection focuses on technique mastery, frequency of catheterisation, and any device-related issues.

Who should consider this trial

Good fit: Adults (≥18) with neurogenic or non-neurogenic bladder dysfunction who were trained in intermittent self-catheterisation, can self-catheterize at least twice daily (with a healthcare recommendation of ≥4 times/day), expect to continue ISC for at least six months, and have chosen Coloplast SpeediCath or Luja catheters.

Not a fit: People who cannot perform self-catheterisation, who are pregnant or otherwise legally/medically vulnerable, who do not plan to use Coloplast catheters, or who require a different catheter approach are unlikely to benefit from the findings.

Why it matters

Potential benefit: If successful, the results could help clinicians and patients choose the catheter design most likely to improve comfort, adherence and long-term independence in bladder management.

How similar studies have performed: Previous research has shown hydrophilic ready-to-use catheters like SpeediCath often yield higher patient satisfaction and fewer complications than uncoated catheters, but head-to-head data comparing these specific Coloplast designs (SpeediCath vs Luja) are limited.

Eligibility criteria

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.

Where this trial is running

Leuven

• UZ Leuven — Leuven, Belgium (Recruiting)

Study contacts

• Study coordinator: François Hervé

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