Introduction: According to the Wound Ostomy Continence Nursing Society's Continence Committee, the incidence of fecal incontinence (FI) can occur from 18% to 37% in an acute care setting. A stool management system has been designed to manage FI in bedridden patients and has proven to be efficacious in wound management and prevention and infection control, provide safer patient outcomes, and enhance ease of nursing.
Objective: This study aims to evaluate the safety and efficacy of an intrarectal device intended to manage fecal incontinence in hospitalized bedridden patients through nonclinical and clinical testings.