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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
107
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.
UZ Leuven
Leuven, Belgium
RECRUITINGSelf-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.
Time frame: At 6 months.
Self-Questionnaire responses on criteria for patient's initial Coloplast catheter selection choice.
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.
Time frame: Day 0 (at inclusion visit).
Five-Point scale scores for patient's satisfaction with Coloplast catheter.
Satisfaction and ease of learning are each rated on 5-point scales, where higher scores denote higher satisfaction or greater ease.
Time frame: 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).
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.
Time frame: At 3 to 12 weeks AND at 6 months.
Patient's final choice criteria for the catheter selection variables.
Participants report the type of catheter most frequently used.
Time frame: At 6 months.
Adherence rates to Intermittent Self-Catheterization (ISC) protocol.
Participants report their average daily catheterization frequency compared to the prescribed regimen; higher self-reported adherence indicates better compliance with the ISC protocol.
Time frame: At 6 months.
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