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

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.

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.