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


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.