RElax & feeL at EASE (RELEASE)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorStefania Musco
About this trial
This multicenter, parallel-group, randomized controlled trial (RELEASE) aims to evaluate the efficacy of two educational approaches on acceptance and adherence to intermittent catheterization (IC) among adult male patients. Participants requiring IC training will be randomized to either an enhanced educational intervention (informational booklet, video tutorial, and standard training) or standard clinical practice training alone. The primary outcome is the change in Intermittent Catheterization Acceptance Test (I-CAT) scores over three months. Secondary outcomes include adherence (I-CAS), urinary symptoms (USQNB-IC), patient autonomy, satisfaction with assistive technology (QUEST), and functional abilities. The study seeks to identify the most effective educational strategy to improve psychological acceptance, promote adherence, and reduce complications in patients performing IC, ultimately supporting patient-centered care and health system efficiency.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male patients aged 18 years or older.
Diagnosed with neurogenic bladder requiring self-managed intermittent catheterization (IC).
Currently performing IC or newly prescribed IC.
Able to provide informed consent and understand study instructions.
Disqualifiers
Presence of cognitive impairment limiting ability to understand or perform IC independently.
Severe upper limb motor deficits preventing independent catheterization.
Active urinary tract infection at baseline.
Participation in another interventional study that could interfere with outcomes.
Trial design
Design model
Parallel
Treatments tested in this trial
Enhanced Educational Program for Intermittent Catheterization
Other interventionParticipants in this group receive an enhanced educational program for intermittent catheterization (IC), including an informational booklet, a specifically designed video tutorial, and standard clinical practice training. The program aims to improve psychological acceptance, adherence, and self-efficacy by providing comprehensive and patient-centered educational materials in addition to standard care.
Standard Education Group
Other interventionParticipants in this group will receive standard clinical practice training for intermittent catheterization (IC), as routinely provided in participating healthcare centers. This training focuses on basic procedural skills and practical education necessary to perform IC independently, without additional enhanced educational materials such as booklets or video tutorials.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Enhanced Educational Program for Intermittent CatheterizationExperimental treatment 1 intervention
Group B: Standard Education GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Intermittent Catheterization Acceptance (I-CAT) Score
Change in psychological acceptance of intermittent catheterization measured using the Intermittent Catheterization Acceptance Test (I-CAT). The I-CAT assesses acceptance attitudes toward IC, including psychological readiness and emotional adaptation. Higher scores indicate greater acceptance.
Time frame
Baseline (T0) to 3 months (T2)Secondary outcomes
1
Adherence to Intermittent Catheterization (I-CAS Score)
Adherence to intermittent catheterization practices measured by the Intermittent Catheterization Adherence Scale (I-CAS). The scale evaluates the frequency and consistency of IC behaviors. Higher scores indicate greater adherence.
Time frame
Baseline (T0) to 3 months (T2)2
Urinary Symptoms Severity (USQNB-IC)
Severity of urinary symptoms measured by the Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheterization (USQNB-IC). This assesses frequency and severity of symptoms related to bladder dysfunction and catheterization.
Time frame
Baseline (T0) to 3 months (T2)3
Patient Autonomy Level
Self-reported autonomy in performing intermittent catheterization, assessed through specific questions evaluating confidence and independence in IC management.
Time frame
Baseline (T0) to 3 months (T2)4
Satisfaction with Assistive Technology (QUEST 2.0)
Satisfaction with assistive technology measured using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0). Higher scores reflect greater satisfaction with IC-related aids and support tools.
Time frame
3 months (T2)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Stefania Musco
Lead sponsor
Careggi Hospital
Sponsor institution
Source ClinicalTrials.gov
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