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


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.

Figure 2.

Comparison of in situ radial pressures of intrarectal balloon catheter (IBC) devices versus the stool management kit (SMK). IBC-A: Flexi-Seal SIGNAL FMS (ConvaTec, Bridgewater, NJ); IBC-B: InstaFlo Bowel Catheter System (Hollister, Libertyville, IL); IBC-C: DigniCare (Bard Medical, Covington, GA)

Figure 3.

Comparison of insertion and withdrawal forces of intrarectal balloon catheter (IBC) versus the stool management kit (SMK).

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.

Figure 4.

Comparison of diverter lumen during simulated rest and peristalsis. SMK: stool management kit; IBC: intrarectal balloon catheter

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.