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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Self-Questionnaire responses on final criteria for Coloplast catheter selection associated with patient satisfaction. [Срок оценки: At 6 months.]

Вторичные конечные точки (5)

• Self-Questionnaire responses on criteria for patient's initial Coloplast catheter selection choice. [Срок оценки: Day 0 (at inclusion visit).]
• Five-Point scale scores for patient's satisfaction with Coloplast catheter. [Срок оценки: 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). [Срок оценки: At 3 to 12 weeks AND at 6 months.]
• Patient's final choice criteria for the catheter selection variables. [Срок оценки: At 6 months.]
• Adherence rates to Intermittent Self-Catheterization (ISC) protocol. [Срок оценки: At 6 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• UZ Leuven — Leuven

Публикации

• Averbeck MA, Kennelly M, Thiruchelvam N, Konstantinidis C, Chartier-Kastler E, Krassioukov A, Landauro M, Jacobsen L, Vaabengaard R, Islamoska S. Risk factors for urinary tract infections associated with lower quality of life among intermittent catheter users. Br J Nurs. 2023 Oct 12;32(18):S8-S16. doi: 10.12968/bjon.2023.32.18.S8. PMID 37830866
• Kennelly M, Thiruchelvam N, Averbeck MA, Konstatinidis C, Chartier-Kastler E, Trojgaard P, Vaabengaard R, Krassioukov A, Jakobsen BP. Adult Neurogenic Lower Urinary Tract Dysfunction and Intermittent Catheterisation in a Community Setting: Risk Factors Model for Urinary Tract Infections. Adv Urol. 2019 Apr 2;2019:2757862. doi: 10.1155/2019/2757862. eCollection 2019. PMID 31065264
• 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. PMID 28090660
• 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. PMID 23587630
• Game X, Phe V, Castel-Lacanal E, Forin V, de Seze M, Lam O, Chartier-Kastler E, Keppenne V, Corcos J, Denys P, Caremel R, Loche CM, Scheiber-Nogueira MC, Karsenty G, Even A. Intermittent catheterization: Clinical practice guidelines from Association Francaise d'Urologie (AFU), Groupe de Neuro-urologie de Langue Francaise (GENULF), Societe Francaise de Medecine Physique et de Readaptation (SOFMER) PMID 32220571
• Stensballe J, Looms D, Nielsen PN, Tvede M. Hydrophilic-coated catheters for intermittent catheterisation reduce urethral micro trauma: a prospective, randomised, participant-blinded, crossover study of three different types of catheters. Eur Urol. 2005 Dec;48(6):978-83. doi: 10.1016/j.eururo.2005.07.009. Epub 2005 Aug 2. PMID 16126331
• Salomon J, Gory A, Bernard L, Ruffion A, Denys P, Chartier-Kastler E. [Urinary tract infection and neurogenic bladder]. Prog Urol. 2007 May;17(3):448-53. doi: 10.1016/s1166-7087(07)92346-5. French. PMID 17622075
• Scotland KB, Lange D. Prevention and management of urosepsis triggered by ureteroscopy. Res Rep Urol. 2018 Jul 5;10:43-49. doi: 10.2147/RRU.S128071. eCollection 2018. PMID 30013956

Идентификаторы

NCT: NCT07355803 · EVA-Belgium

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗