Clinical Trial

RElax & feeL at EASE (RELEASE)

Study acronym: RELEASE
Not Yet Recruiting
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Record status
This record was last updated July 24, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Trial Details
NCT Number NCT07084376
Lead Sponsor Stefania Musco
Conditions Incontinence, Neurogenic Bladder Dysfunction, Urinary Retention
Enrollment 64 participants
Start Date 2025-09-01
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-07-24