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

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. 

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.

Less force exerted on rectal mucosa by SMK compared with IBCs
In vitro testing and analysis of clinical literature revealed that the average radial pressure exerted on rectal mucosa by SMK in 5 patients was lower compared with all 3 IBCs (21.2 mm Hg vs. IBC-A, 81.2 mm Hg; IBC-B, 77.8 mm Hg; IBC-C, 32.1 mm Hg) (Figure 2). Insertion and withdrawal forces of SMK were lower compared with IBC-A (Figure 3). Accidental expulsion force for SMK was found to be 10.38 ± 0.92 N; the same test with IBC-A resulted in significantly higher forces and destruction of the test fixture due to inflated balloon traversing the anal canal.

The SMK does not rely on strong anal tone while in situ
Poor sphincter tone precludes fecal management and increases risks for dislodgement and leakage of the IBCs. However, the self-expanding diverter design of the SMK obviates the need to anchor upon the anorectal junction, thrice expanding the eligibility of closed-system fecal containment to patients with weak or no sphincter tone. It also was observed in patients using SMK that the diverter, lattice, and indwelling component was able to align and adhere itself to the rectal anatomy during simulated rest and peristalsis, unlike a balloon-based catheter device that has a high possibility of collapsing and creating leakage points (Figure 4). Also, the SMK was able to maintain a larger lumen (3.8 in² vs. IBC-A, 0.55 in²; IBC-B, 0.55 in²; IBC-C, 1.4 in²) than the IBCs during both resting and peristalsis states. 

The SMK assists in providing an infection-free recovery
A value-assessment evaluation of SMK used in the treatment of 20 patients with multiple comorbidities revealed that a majority of patients presented with CDI, gastrointestinal bleeds, or large sacral/perineal wounds (Table). The SMK successfully contained effluent in unconscious and conscious patients and reported just 2 cases of expulsion and a mean rate of 1.1 device reinsertions. The majority (86%; 17/20) of patients saw minor or no leakage. No adverse events related to device usage were observed in the patients during the trial duration, and no hospital-acquired CDI cases were reported during the study despite 8 instances on admission. Several patients also reported successive deployment of SMK after IBC dislodgments. The majority of surveyed nurses (75%, n = 49) stated they would be an advocate for SMK and prefer it as a replacement over IBCs.

Results from the current study show that the SMK is a far superior and safer alternative to the conventional devices used for fecal diversion. The SMK has less impact upon the rectal mucosa as compared with the IBCs during insertion, in situ use, withdrawal, and accidental expulsions. The self-expanding diverter design creates a custom seal along the rectal wall and obviates the need for balloon cuff-based anchoring to the anorectal junction, thereby increasing the fecal containment capability in a closed system, even in patients with weak or no sphincter tone. This technology makes it possible for the SMK to be used for longer durations in situ while the stool consistency increases over time. The thin transit sheath of the device reduces the risk of anal sphincter dysfunction and foreign body sensation.

The clinical evaluation of adult patients showed that the innovative non-balloon technology of the SMK also decreased undesired leakage outcomes by diverting liquid to a semi-formed fecal effluent in a collection bag and acted as a barrier for perineal and sacral skin, thereby resulting in quicker mucosal healing and better fecal management. Furthermore, the expanding, conformable technology of the SMK enables it to be used in the treatment of patients with multiple comorbidities, thus providing extended clinical and economic benefits.

An epidemiological study for FI have reported its prevalence between 1.0% and 7.4% in healthy individuals and up to 25.0% in institutionalized patients.³⁶ Nonsurgical fecal diversion has been performed in cases with severe perianal sepsis through IBCs. However, there are disadvantages reported with IBC usage, such as autonomic dysreflexia, pressure necrosis due to balloon inflation, and hemorrhage in the rectum following prolonged use of the device.³⁷ In addition, the large bore catheter can aggravate sphincter dysfunction and cause a significant foreign-body sensation. Leakage exposes the patients to potential skin injury, which can lead to several microbial infections.^38,39 A majority of incontinent patients with FI (70.4%) have dysfunction of external or internal anal sphincters or both.^32,40 Intrarectal balloon FMSs rely on the function of external and internal anal sphincters, rectal sensation, and compliance to maintain fecal continence. However, the SMK does not rely on a strong anal tone while in situ and thus can be used in incontinent patients with varying levels of anal sphincter tones. The risk of infection transmission is reduced in 3 ways: (1) avoidance of manual insertion by the health care worker using their finger, (2) decreased risk of peripheral leakage of stool from higher pressure buildup or poor sphincter tone, and (3) the unintended expulsion of the device.

Research in the area of cost management and nursing care with FMS is scarce, and, as a result, patients with FI are burdened financially.^1,41 Most commonly, the costs are associated with absorbent and containment products, increased involvement of health care workers, and environmental cleaning resources. These elements create an unnecessary financial liability that is unfortunately not borne by the health payers and hence passed upon the hospitals or eventually to the patients.^42-44 The SMK facilitates expedited recovery and enhanced fecal management, which can lead to a positive impact on health care costs, contribute significant financial savings for both hospitals and patients, and add more dignity to patient care. Nursing, patient, and caregiver satisfaction feedback have shown high agreement for usage of SMK as a frontline mode of fecal management. The device was found to be practical, efficient, and patient friendly. 

Further prospective studies and randomized controlled trials using traditional methods of fecal management should be conducted to concretely establish the clinical and economic benefits of SMK in FI management. There is a large potential for this technology to be combined with medication and studied for the collective improvement in the medical condition of patients with FI. Based upon patient feedback within this study, the SMK technology should alleviate embarrassment and discomfort experienced by patients with incontinence to a large extent in a significantly lesser span of time.

A limitation of this study is that it did not evaluate the economic outcomes associated with the SMK.  A prospective study of the direct and indirect costs associated with fecal containment would help in evaluating the cost effectiveness of the SMK when compared with traditional FMSs.

Nonclinical and clinical testing demonstrated that the SMK may be a superior alternative to existing closed-system solutions. The SMK exerts significantly less force upon the anorectal mucosa compared with IBCs during insertion, in situ use, withdrawal, and accidental expulsions. Poor sphincter tone precludes fecal management with IBCs, putting patients at risk for dislodgement and leakage.

The self-expanding diverter design obviates the need to anchor to the anorectal junction, enhancing fecal containment capability even for patients with weak or no sphincter tone. By assuming full rectal lumen, SMK may be used in situ for more extended periods as stool consistency improves. Clinical validation in both controlled and uncontrolled settings successfully established the usage of SMK in adult patients as a safe and effective alternative for fecal effluent diversion and protection for perineal and sacral skin with minimal leakage. There were no adverse effects of the device on the anorectal mucosa. This device may be a safer alternative to IBCs and can be used in more patients with multiple comorbidities.

From the Banner University Medical Center, Tucson, AZ

Address correspondence to:
Ashlee Garcia, BSN, RN, CWOCN, CFCN
Banner University Medical Center – South Campus
Wound Care
2800 East Ajo Way
Tucson, AZ 85713
farrer71@gmail.com

Disclosure: The authors disclose no financial or other conflicts of interest. Shivam Mistra and Emily Reichart provided editorial assistance on behalf of Consure Medical (San Francisco, CA). This paper was presented as a poster at the 2017 Symposium on Advanced Wound Care Spring in San Diego, CA