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
Qualifiers
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
Treatments tested in this trial
- Enhanced Educational Program for Intermittent Catheterization
- Standard Education Group
Treatment groups
64 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Stefania Musco
Lead sponsor
Careggi Hospital
Sponsor institution
Source ClinicalTrials.gov