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

Ashlee Garcia, BSN, RN, CWOCN, CFCN; Sally Fung, RN, MS; Karen Lou Kennedy-Evans, RN, FNP, APRN-BC


Wounds. 2017;29(12):E132-E138. 

In This Article

Materials and Methods

Five SMK samples were tested and data on 3 IBCs (Flexi-Seal SIGNAL FMS [IBC-A; ConvaTec, Bridgewater, NJ], InstaFlo Bowel Catheter System [IBC-B; Hollister, Libertyville, IL], and DigniCare [IBC-C; Bard Medical, Covington, GA]) were gathered via a literature review and parallel testing. The radial pressure exerted by SMK was measured in vitro using an equivalent test method used to measure radial forces of cardiovascular stents. Insertion, withdrawal, and expulsion forces were measured using a linear tensile testing machine and a foam-based anorectal model. Pre-insertion diameters and catheter lumen cross-sectional areas were measured.

All samples were then photographed during rest and simulated peristaltic contractions in the model rectum. Expulsion force was measured by withdrawing the devices without following the indicated removal process. A systematic literature review on sphincter dysfunction in patients with FI was conducted utilizing relevant search terms in the PubMed database from May 1993 to June 2015. Articles were included if they reported prevalence or data enabling a calculation of crude prevalence and excluded if they focused on any specific disease state.

In addition, 20 patients with multiple comorbidities, who were admitted to a medical-surgical intensive care unit and acute care telemetry unit of a tertiary care hospital in Tucson, Arizona, were enrolled for treatment in an uncontrolled, pilot, value-assessment evaluation of the SMK. Throughout the study, device efficacy (diversion, expulsion), hospital-acquired CDI rate, and nursing preference over existing IBCs were surveyed.