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

Abstract and Introduction


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.

Materials and Methods. 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.

Results. 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.

Conclusions. 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.


Fecal incontinence (FI), also known as bowel incontinence, is the untimely, involuntary discharge of stool. Apart from being a socially and psychologically devastating condition for the affected patient, FI, if not managed properly, can lead to nosocomial infections (hospital-acquired), cause significant complications to the patient's health and wellbeing, and also affect health care workers.[1–4] The risk of transmission of nosocomial infections, such as norovirus and Clostridium difficile, in acute care environments is a persistent problem in the management of FI. Diarrhea and liquid FI are prevalent conditions affecting 18% to 37% of acute care patients.[2,5,6] Exposure to fecal pathogens presents a significant infection control challenge, leading to severe skin breakdown, bloodstream infections, and spread of harmful pathogens.

Conventional intrarectal balloon catheters (IBCs) are manually inserted into the anorectal junction of the anal canal. Although IBCs have been shown to reduce the incidence of skin breakdown and spread of nosocomial infections,[7] clinical use of IBCs has reported secondary complications like mucosal bleeding, anal erosion, sphincter dysfunction, and persistent discomfort.[8–14] Intrarectal balloon catheters rely on a large silicone retention balloon that anchors to the anorectal junction. Poor sphincter tone precludes patients for management with IBCs, as it puts them at high risk for sudden device expulsion. Documented clinical findings suggest in situ pressures exerted by IBCs can increase beyond the hydrostatic pressure of rectal microvasculature.[15–18] Furthermore, IBCs require manual placement into the rectal vault, creating an extensive insertion profile and exposing rectal mucosa to high shear forces. The clinical literature indicates 14 mm Hg to 22 mm Hg as an optimal range for creating a sufficient seal without risking necrosis.[19] Higher cuff pressures are known to compress mucosal arteries and impair blood flow, with total occlusion of arteries occurring at 36 mm Hg.[20] In addition, IBCs provide a substantially smaller in situ drainage cross-sectional area compared with the cross-sectional area of the rectum.[18,21–27] Poor drainage increases intrarectal pressure and risk of spontaneous expulsion. Also, regular peristaltic contractions may collapse or occlude IBCs, especially if overinflated, and thus compromise the rectal seal and cause leakage. These challenges necessitate the development of new fecal management systems (FMSs) that can provide far superior containment and help significantly decrease the risk of anorectal injury, fecal leakage, and infection transmission. Novel and improved FMSs can prevent contact between a patient's stool and health care workers, avoid environmental contamination of the patient area, and provide safe ongoing diversion of stool.[28–30]

The financial costs associated with uncontrolled FI are significant. Fecal contamination-related complications involving hospital-acquired pressure injuries, catheter-associated urinary tract infections, and hospital-acquired C difficile infections (CDI) can add up to $10 700 to $30 049 per hospitalization.[31,32] Medical complications, including nosocomial infections, result in significant post discharge insurance claims. In some cases, this process can be drawn out over the course of years, depending on the infection, severity, and patient health status.[33] Therefore, the development of a cost-efficient FMS can lead to a reduction in costs related to consumables, nursing time, clinical complications, and risk of nosocomial transmission. Additional benefits of improved FMSs can include increased patient eligibility, expanded use cases, and improved clinical outcomes while increasing the comfort and dignity afforded to patients. Furthermore, providers may avoid impacts from the Centers for Medicare and Medicaid Services/payer penalties associated with poor outcomes and decreased patient satisfaction.[34,35]

The purpose of this study is to investigate a stool management kit (SMK; Qora SMK; Consure Medical, San Francisco, CA), which utilizes a non-balloon-based technology for fecal diversion. This device was developed at Stanford Byers Center for Biodesign and Stanford University Hospital (Stanford, CA). It is approved by the US Food and Drug Administration for fecal diversion usage for up to 29 days. The primary component of the device is a flexible, diverter, lattice, and indwelling component that deploys above the anorectal junction. The diverter is connected to a thin transit sheath that traverses the anal canal and drains into a collecting bag and aids in mucosal healing (Figure 1). The soft, pliable, self-expanding fecal diverter enables smooth access and automatic deployment. It is anatomically placed as to avoid foreign body sensation, remain in situ independent of anal tone, provide a custom rectomucosal seal, and maintain the natural rectal lumen diameter. The pilot study presented herein discusses the benchtop and clinical evaluation of SMK. The results show the device as a potentially safer and more widely applicable alternative to IBCs.

Figure 1.

The stool management kit for bedridden adults.