A Pilot Clinical Study of a Safe and Efficient Stool Management System in Patients With Fecal Incontinence

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.

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.

An uncontrolled pilot evaluation in 20 patients was performed as part of a value-based purchasing evaluation at a tertiary hospital in Tucson, Arizona, to assess safety and efficacy in infection control and wound care. The company-provided engineering bench-top studies of insertion and withdrawal forces of the device versus existing intrarectal balloon catheters also were evaluated.

The device has broader patient eligibility and potentially allows 3 times more FI patients to be managed safely. It has lower intrarectal pressures compared with indwelling balloon catheters.

This study, along with pilot clinical findings, suggests that this technology minimizes the pressure exerted on the rectal wall. There were significantly fewer forces against the anorectal mucosa compared with the cuff-based catheter during insertion, withdrawal, and accidental expulsion.