[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599429":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":28,"locations":24,"responsibleParty":34,"collaborators":24,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":40,"sex":46,"minAge":47,"maxAge":24,"enrollmentInfo":48,"targetDuration":24,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":66,"whyStopped":24,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":24},{"fullName":5,"class":6},"Careggi Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Enhanced Educational Program for Intermittent Catheterization","EXPERIMENTAL","Participants in this arm will receive an enhanced educational intervention comprising an informational booklet, a video tutorial specifically designed for self-managed intermittent catheterization (IC), and standard clinical practice training. This comprehensive approach aims to improve psychological acceptance, adherence, and self-efficacy in performing IC",[13],"Other: Enhanced Educational Program for Intermittent Catheterization",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Education Group","ACTIVE_COMPARATOR","Participants receive standard clinical practice training for self-managed intermittent catheterization (IC) as typically provided in routine care settings. This arm serves as the active comparator to evaluate the additional impact of the enhanced educational intervention.",[19],"Other: Standard Education Group",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"Participants 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.",[9],null,{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Participants 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.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Stefania Musco, MD","CONTACT","+39 3476383462","muscos@aou-careggi.toscana.it",{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Stefania Musco","MD","100599429","relax--feel-at-ease-release-100599429",false,"NCT07084376","RElax & feeL at EASE (RELEASE)","A Multicenter, Parallel-group, Randomized Controlled Trial to Assess the Efficacy of Two Different Educational Approaches on Intermittent Catheter-related Acceptance and Patient-Reported Outcome Measures (PROMs): RElax & feeL at EASE (RELEASE)","RELEASE","Inclusion Criteria:\n\n* Male patients aged 18 years or older.\n* Diagnosed with neurogenic bladder requiring self-managed intermittent catheterization (IC).\n* Currently performing IC or newly prescribed IC.\n* Able to provide informed consent and understand study instructions.\n* Able to understand and complete study questionnaires in Italian.\n\nExclusion Criteria:\n\n* Presence of cognitive impairment limiting ability to understand or perform IC independently.\n* Severe upper limb motor deficits preventing independent catheterization.\n* Active urinary tract infection at baseline.\n* Participation in another interventional study that could interfere with outcomes.\n* Any condition that, in the opinion of the investigators, makes the patient unsuitable for study participation.","MALE","18 Years",{"count":49,"type":50},64,"ESTIMATED","INTERVENTIONAL",[53],"NA","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.",[56,57,58],"Incontinence","Neurogenic Bladder Dysfunction","Urinary Retention",[60,61,62,63,64,65],"Intermittent catheterization","Self-catheterization","Patient education","Adherence","Acceptance","Male urology","NOT_YET_RECRUITING","2025-07-17",{"date":69,"type":70},"2025-07-24","ACTUAL",{"date":72,"type":50},"2025-09-01",{"date":74,"type":50},"2026-09-30",{"name":36,"class":6}]