Neurogenic Bladder DisorderEVANCT07355803
Define Final Selection Choice Criteria for a Coloplast Catheter Ensuring Highest Patient Satisfaction Via Surveys (EVA).
A study testing Questionnaires : Patient questionnaire on catheter use and satisfaction, IC-Di-Q, and I-CAT in people with Neurogenic Bladder Disorder and Non-Neurogenic Bladder, run by Coloplast NV/SA at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Bladder Disorder, Non-Neurogenic Bladder, Bladder Dysfunction
- What is being tested?
- Questionnaires : Patient questionnaire on catheter use and satisfaction, IC-Di-Q, and I-CAT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Oct 2025to 5 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 9Show fewer
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EVA-study on Catheter Selection Criteria at Start of Self-catheterization
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Neurogenic Bladder Disorder, Non-Neurogenic Bladder, Bladder Dysfunction, Urinary Retention
- Being tested
- Questionnaires : Patient questionnaire on catheter use and satisfaction, IC-Di-Q, and I-CAT
- Medical subject headings
- Urinary Bladder, Neurogenic, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires : Patient questionnaire on catheter use and satisfaction, IC-Di-Q, and I-CATOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaires : Patient questionnaire on catheter use and satisfaction, IC-Di-Q, and I-CAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 months.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start21 Oct 2025
- Primary completion5 Aug 2026
- Study completion5 Aug 2026
Why it stopped: The study was prematurely terminated due to low recruitment (22/107 participants), making the planned sample size unattainable and limiting the robustness and interpretability of the study results. This termination was not due to safety issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Neurogenic Bladder DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast NV/SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger Houben, PhD MBA, Study director, Coloplast A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355803
- Sponsor's protocol ID
- EVA-Belgium
- Acronym
- EVA
- Status last verified
- Jan 2026
- First submitted
- 5 Dec 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37830866Kennelly 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.
PubMed 31065264Guinet-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.
PubMed 28090660Chartier-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.
PubMed 23587630Game 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) and Societe Interdisciplinaire Francophone d'UroDynamique et de Pelvi-Perineologie (SIFUD-PP). Prog Urol. 2020 Apr;30(5):232-251. doi: 10.1016/j.purol.2020.02.009. Epub 2020 Mar 24.
PubMed 32220571Stensballe 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.
PubMed 16126331Salomon 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.
PubMed 17622075Scotland 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.
PubMed 30013956Herve F, Ragolle I, Amarenco G, Viaene A, Guinet-Lacoste A, Bonniaud V, Everaert K. Assessment of Intermittent Self-Catheterization Procedures in Patients with Neurogenic Lower Urinary Tract Dysfunction: Dutch Translation and Validation of the Intermittent Catheterization Satisfaction Questionnaire, Intermittent Catheterization Acceptance Test, Intermittent Self Catheterization Questionnaire and Intermittent Catheterization Difficulty Questionnaire. Urol Int. 2019;102(4):476-481. doi: 10.1159/000499884. Epub 2019 Apr 18.
PubMed 30999304Guinet-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.
PubMed 25327888Girotti ME, MacCornick S, Perisse H, Batezini NS, Almeida FG. Determining the variables associated to clean intermittent self-catheterization adherence rate: one-year follow-up study. Int Braz J Urol. 2011 Nov-Dec;37(6):766-72. doi: 10.1590/s1677-55382011000600013.
PubMed 22233982Thiruchelvam N, Hashim H, Forman CR, Jacobsen L, Sperup T, Andersen K. New compact micro-hole zone catheter enables women to achieve effective bladder emptying without flow-stops. Br J Nurs. 2024 Sep 19;33(17):834-843. doi: 10.12968/bjon.2024.0212.
PubMed 39302905Gabbe BJ, Nunn A. Profile and costs of secondary conditions resulting in emergency department presentations and readmission to hospital following traumatic spinal cord injury. Injury. 2016 Aug;47(8):1847-55. doi: 10.1016/j.injury.2016.06.012. Epub 2016 Jun 7.
PubMed 27343134Biering-Sorensen F. Urinary tract infection in individuals with spinal cord lesion. Curr Opin Urol. 2002 Jan;12(1):45-9. doi: 10.1097/00042307-200201000-00009.
PubMed 11753133Biering-Sorensen F, Bagi P, Hoiby N. Urinary tract infections in patients with spinal cord lesions: treatment and prevention. Drugs. 2001;61(9):1275-87. doi: 10.2165/00003495-200161090-00004.
PubMed 11511022
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVA-study on Catheter Selection Criteria at Start of Self-catheterization
- ClinicalTrials.gov ID
- NCT07355803
- Acronym / sponsor ID
- EVA / EVA-Belgium
- Conditions
- Neurogenic Bladder Disorder, Non-Neurogenic Bladder, Bladder Dysfunction, Urinary Retention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was prematurely terminated due to low recruitment (22/107 participants), making the planned sample size unattainable and limiting the robustness and interpretability of the study results. This termination was not due to safety issues.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Coloplast NV/SAIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 5 Aug 2026 (actual)
- Study completion
- 5 Aug 2026 (actual)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coloplast | Experimental | Other: Questionnaires : Patient questionnaire on catheter use and satisfaction, IC-Di-Q, and I-CATThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (10 listed)
- Vulnerable subject with regard to the current regulation:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires : Patient questionnaire on catheter use and satisfaction, IC-Di-Q, and I-CATThe 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. | Other | Coloplast |
Primary outcome
Self-Questionnaire responses on final criteria for Coloplast catheter selection associated with patient satisfaction.
Time frame: At 6 months.
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.
5 secondary outcomes
Self-Questionnaire responses on criteria for patient's initial Coloplast catheter selection choice.
Time frame: Day 0 (at inclusion visit).
Five-Point scale scores for patient's satisfaction with Coloplast catheter.
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).
Time frame: At 3 to 12 weeks AND at 6 months.
Patient's final choice criteria for the catheter selection variables.
Time frame: At 6 months.
Adherence rates to Intermittent Self-Catheterization (ISC) protocol.
Time frame: At 6 months.
Results and safety
The study was stopped early (reason given: The study was prematurely terminated due to low recruitment (22/107 participants), making the planned sample size unattainable and limiting the robustness and interpretability of the study results. This termination was not due to safety issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background: PubMed 37830866Averbeck 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.
- Background: PubMed 31065264Kennelly 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.
- Background: PubMed 28090660Guinet-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.
- Background: PubMed 23587630Chartier-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.
- Background: PubMed 32220571Game 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) and Societe Interdisciplinaire Francophone d'UroDynamique et de Pelvi-Perineologie (SIFUD-PP). Prog Urol. 2020 Apr;30(5):232-251. doi: 10.1016/j.purol.2020.02.009. Epub 2020 Mar 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Houben, PhD MBA study director
Coloplast A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires : Patient questionnaire on catheter use and satisfaction, IC-Di-Q, and I-CAT in people with Neurogenic Bladder Disorder and Non-Neurogenic Bladder, run by Coloplast NV/SA at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was prematurely terminated due to low recruitment (22/107 participants), making the planned sample size unattainable and limiting the robustness and interpretability of the study results. This termination was not due to safety issues.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Questionnaire responses on final criteria for Coloplast catheter selection associated with patient satisfaction. (time frame: At 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07355803, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.