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American Journal of Critical Care. 2007;16: 384-393
Copyright © 2007 by the American Association of Critical-Care Nurses.
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Clinical Evaluation of a Flexible Fecal Incontinence Management System

By Anantha Padmanabhan, MD, Mark Stern, MD, Judith Wishin, RN, BSN, Mari Mangino, RN, Karen Richey, RN, Mary DeSane, RN, BSN on behalf of the Flexi-Seal Clinical Trial Investigators Group. Anantha Padmanabhan is chair of the Department of Surgery at Mt Carmel East Hospital and clinical assistant professor of surgery at Ohio State University in Columbus. Mark Stern is the founder of the Atlanta Academic Research Group in Decatur, Georgia. Judith Wishin is the senior clinical research coordinator for the surgical intensive care unit at the University of Florida, Gainesville. Mari Mangino is a clinical nurse research coordinator at Forum Health in Youngstown, Ohio. Karen Richey is the senior clinical research coordinator at the Arizona Burn Center in Phoenix. Mary DeSane is the operations manager in the Office of Clinical Research at Jersey Shore University Medical Center, Neptune, New Jersey.

Corresponding author: Anantha Padmanabhan, MD, FACS, FASCRS, 5965 E Broad St, Suite 250, Columbus, OH 43213 (e-mail: apaddy{at}phy.mchs.com).


   Abstract
Top
 Abstract
Methods
 Results
 Discussion
 Conclusion
 References
 
Background Management of fecal incontinence is a priority in acute and critical care to reduce risk of perineal dermatitis and transmission of nosocomial infections.

Objective To evaluate the safety of the Flexi-Seal Fecal Management System in hospitalized patients with diarrhea and incontinence.

Methods A prospective, single-arm clinical study with 42 patients from 7 hospitals in the United States was performed. The fecal management system could be used for up to 29 days. The first 11 patients (all from critical care) underwent endoscopic proctoscopy at baseline; 8 of these had endoscopy again after treatment. The remaining 31 patients (from critical or acute care) did not have endoscopy.

Results Rectal mucosa was healthy after use of the device in all patients who had baseline and follow-up endoscopy. Physicians and nurses reported that the system was easy to insert, remove, and dispose of; its use improved management of fecal incontinence; and it was practical, caregiver- and patient-friendly, time-efficient, and efficacious. Skin condition improved or was maintained in more than 92% of patients. Patients’ reports of discomfort, pain, burning, or irritation were uncommon. Adverse events were reported for 11 patients (26%). Death (considered unrelated to study treatment) occurred in 5 patients, 2 patients had generalized skin breakdown, and 1 patient had gastrointestinal bleeding after 4 days of treatment.

Conclusions The fecal management system can be used safely in hospitalized patients with diarrhea and fecal incontinence. Additional well-designed, controlled clinical trials may help to measure clinical and economic outcomes associated with the device.

Diarrhea is a common problem that complicates treatment and may worsen patients’ outcomes. In a prospective study,1 33% of hospitalized patients had fecal incontinence during hospitalization, including more than twice as many patients in the intensive care unit (ICU) compared with acute care units (58% vs 24%). A total of 79% patients had liquid or semiliquid stool, and these patients were 11 times more likely than patients with hard or soft formed stool to have fecal incontinence. Fecal incontinence is an established risk factor for pressure ulcers,2–4 which increase morbidity, mortality, length of hospital stay, and treatment costs.5 It is also a risk factor for transmission of nosocomial infection.6 Therefore, management of fecal incontinence is a priority in ICUs and acute care units.

The first step in management is to identify and, if possible, eliminate the source of the incontinence.7 However, fecal incontinence in hospitalized patients, particularly in intensive care, often is of unknown cause, the result of multiple factors, or the result of another treatment that cannot be discontinued. Therefore, interventions that divert and contain feces often are essential to reduce perineal dermatitis in hospitalized patients. Protection of the skin from exposure to moisture and chemical damage from stool becomes a priority.

The Flexi-Seal Fecal Management System (FMS; ConvaTec, Division of E. R. Squibb & Sons, LLC, Princeton, New Jersey) is indicated for the fecal management of patients with little or no bowel control and liquid or semiliquid stool.8 The device consists of a soft silicone cannula approximately 1 m long with an annular silicone low-pressure balloon at the distal end and a pouch flange adapter at the proximal end that connects to the collection bag. The catheter balloon is collapsed to permit nontraumatic insertion into the rectal vault. The balloon is wrapped around the free end of the tubing and has a finger pocket for introducing the catheter through the anal sphincter (Figure 1AGo). The catheter cannula is 23 mm in diameter and collapses to 8 mm in diameter for insertion.


Figure 1
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  		Figure 1 A: The catheter for the Flexi-Seal Fecal Management System consists of a soft silicone cannula approximately 1 m long with an annular silicone low-pressure balloon at the distal end and a pouch flange adapter at the proximal end. B: After insertion through the anal sphincter, the balloon is inflated with 45 mL of water or isotonic sodium chloride solution to a diameter of about 53 mm.

 
The balloon is coated with lubricating jelly and is inserted through the anal sphincter until the balloon is well inside the rectal vault. The balloon is then inflated with 45 mL of water or saline to a diameter of about 53 mm with less than 57 mm Hg pressure supplied by a standard syringe (Figure 1BGo). The cannula has 2 lumens, each 1 mm in diameter, integrated with the wall. Each lumen is interconnected to its own free length of silicone tubing bifurcating from the main cannula approximately halfway between the proximal and distal ends. The free end of each piece of tubing has a standard Luer valve connector. One lumen is interconnected with the balloon and serves as an inflation-deflation line. The proximal end of the cannula is stretched over a plastic adapter that can be hung from the bed rail and used to attach the collection bag.

This study was conducted as part of the development of FMS before the system was marketed in the United States. Our primary objective was to describe the safety of the device in hospitalized patients who were experiencing diarrhea and incontinence. Secondary objectives included evaluations of FMS performance and ease of use.


   Methods
Top
 Abstract
 Methods
Results
 Discussion
 Conclusion
 References
 
Study Design
A prospective, single-arm, descriptive clinical study with 42 patients from 7 hospitals in the United States was done. Each study center had at least one physician as the investigator, and most centers had a registered nurse who was the study coordinator (see "Acknowledgments"). The study protocol was approved by an institutional review board for each study site, and the study was conducted in accordance with the principles of good clinical practice and the ethical standards set forth in the Helsinki Declaration of 1975.


Management of fecal incontinence is a priority in ICUs and acute care units.

 


Our primary objective was to describe the safety of the FMS device in hospitalized patients who had diarrhea and incontinence.

 

Eligibility Criteria
At each site, the investigator or study coordinator selected hospitalized patients of legal consenting age for inclusion if the patients had incontinence and liquid or semiliquid stool. Key exclusion criteria included recent rectal surgery, anastomosis of the lower part of the large bowel within the preceding year, and recent cardiac event requiring hospitalization within the preceding 3 months. Each patient (or legally authorized representative) provided written informed consent.

Interventions and Assessments
Patients could be managed with FMS for up to 29 days, in accordance with the maximum duration of usage indicated in the package insert for the system. The device was removed sooner if an investigator or a study coordinator determined it was no longer clinically indicated.

The first 11 patients were recruited exclusively from ICUs, and endoscopic proctoscopy was performed to assess the condition of the rectal mucosa before insertion of the FMS. These patients were to have endoscopy again after removal of the device. However, endoscopy was completed at the final visit for only 8 patients; among the other 3 patients, 2 died and 1 had final endoscopy deferred because of the patient’s status. When the endoscopic results and a review of adverse events in the first 11 patients indicated no safety concerns, an additional 31 patients were enrolled from ICUs and acute care sites. Endoscopy was not required in these 31 patients. Caregivers, investigators, and study coordinators recorded all adverse events. At each site, the investigator categorized each adverse event according to severity, presumed cause, and seriousness (ie, if the event was fatal, was life-threatening, or prolonged hospitalization).

For study of the performance of the FMS, the following demographic and clinical information was recorded for each patient at baseline: diagnoses, mental response status (alert and responsive, sedated and sluggish, sedated and nonresponsive, comatose, or other), physical response status (responsive to touch or command, responsive to pain only, medication-induced paralysis, or other), consistency of stool (totally liquid, liquid with few solid flecks, or semiliquid), frequency of stool (every 8–12 hours, every 6–8 hours, every 4–6 hours, every 2–4 hours, or continuous), skin care protocol, and presumed cause of diarrhea. At each site, the investigator or study coordinator also used a nonvalidated scale, scored from 0 to 4 (Table 1Go), to rate each patient’s skin condition separately for the perineal and buttocks areas. A digital rectal examination was performed; if fecal impaction was detected, disimpaction was performed and enrollment into the study continued at the discretion of the investigator or study coordinator. The investigator or study coordinator inserted the device and recorded whether it was easy to insert.


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  		Table 1 Skin condition rating scale

 
The nurses (caregivers) directly responsible for care of each patient recorded additional evaluations of FMS performance and tolerability during each day of the study. At each site, the investigator or stud coordinator ensured that all caregivers were instructed on proper use of the FMS and the daily study assessment procedures, and the investigator or study coordinator reviewed the daily caregivers’ assessments. Caregivers recorded whether the device had been expelled from the rectum since the last assessment and, if so, how many times it had been reinserted.

Caregivers classified each occurrence of leakage as incidental (nonproblematic, anticipated leakage with a stool management device) or significant (stool leakage around the device). Incidental leakage was categorized further as one of the following: no moisture or stool detected from rectum, detectable clear wetness visually and to touch, small amount of disclosed wetness with odor, source unknown, or other. Significant leakage was categorized further as one of the following: FMS remained in place but stool had soiled skin and bed linens confined to area protected by absorbent pads, FMS remained in place but stool had soiled skin and bed linens extending beyond areas protected by absorbent pads, FMS was expelled with large amounts of stool soilage, or other.

Caregivers evaluated skin condition daily by using the skin condition rating scale (Table 1Go). If a patient was alert and responsive, caregivers asked about the presence of discomfort, pain, irritation, or burning in the rectal area. Caregivers recorded the presence of odor, the presence of obstruction in the device, and collection bag changes. Using a subjective rating scale from 1 (strongly agree) to 5 (strongly disagree), caregivers rated how well the FMS improved control of fecal incontinence. Care-givers used the same scale from 1 to 5 to rate how FMS compared with other fecal management strategies in regards to being time-efficient, caregiver friendly, practical, efficacious, and patient friendly.

At the final visit, the investigator or study coordinator removed the device and recorded whether the device was easy to remove and whether it was easy to dispose of.

Statistical Analyses
Comparative statistical tests were not performed. Safety summaries included data on all enrolled patients who were treated with the study device. Descriptions of device performance were summarized for the intent-to-treat population, consisting of all enrolled patients who were treated with the study device and had at least one assessment after initial evaluation.


   Results
Top
 Abstract
 Methods
 Results
Discussion
 Conclusion
 References
 
Disposition of Patients
A total of 42 patients were enrolled in the study. The duration of treatment ranged from 1 to 14 (mean, 5.6) days. A total of 35 patients (83%) retained the device until it was removed by an investigator or a study coordinator. In 4 patients (10%), the device was used for less than 24 hours; the remaining 38 patients (90%) had at least one assessment after the baseline assessment and were included in the intent-to-treat population. In all patients, the device was used for less than 29 days. After the first day, use was discontinued in 12 patients (29%) because of the resolution of diarrhea and in 10 patients (24%) because the patients were transferred to another department or were discharged from the hospital; other reasons for discontinuation are summarized in Figure 2Go.


Figure 2
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  		Figure 2 Patient disposition. Numbers in parentheses are percentages. Because of rounding, percentages total more than 100.

 
Baseline Data
Baseline demographics and clinical characteristics of study patients are summarized in Table 2Go. Mean age of patients was 60.7 years, and 62% of patients were female. Most patients (79%) were enrolled from ICUs, 40% were mentally alert and responsive, and 55% were physically responsive to touch. Greater than 90% of patients had stool production continuously or every 2 to 4 hours. Greater than two-thirds of patients had more than one clinical diagnosis. The most commonly identified cause of diarrhea was medication (24%), but the cause was unknown for 57% of patients.


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  		Table 2 Demographics and baseline clinical characteristics

 
Safety
The first 11 patients enrolled had endoscopic proctoscopy to examine the rectal mucosa before insertion of the device. Of these 11 patients, 2 died, 1 had endoscopy deferred because of the patient’s status, and 8 had endoscopic proctoscopy at the end of the study after removal of the device. Rectal mucosa was healthy after FMS use for all 8 patients who had baseline and follow-up endoscopy. Figure 3Go shows sample results from patient 11 before and after use of the FMS.


Figure 3
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  		Figure 3 Representative endoscopic proctoscopy images show healthy rectal mucosa in patient 11 before (A) and after (B) use of the Flexi-Seal Fecal Management System. The device was removed after 5 days of treatment because diarrhea had resolved.

 
Adverse events were reported for 11 (26%) of the 42 patients (Table 3Go). The most frequently reported adverse event was death, which occurred in 5 patients (12%); investigators categorized all deaths as unrelated to study treatment. A total of 2 patients (5%) had generalized skin breakdown with unknown relationship to the study device.


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  		Table 3 Adverse eventsa

 
Serious adverse events were reported for 7 patients (17%): 5 patients died (see previous paragraph), 1 patient (2%) had fever of unknown relationship to use of the FMS, and 1 patient (2%) had gastrointestinal bleeding. The patient with gastrointestinal bleeding had multisystem disease, had been prescribed anticoagulant and antiplatelet therapies, and had gastrointestinal bleeding at the time of admission to the hospital before use of the FMS. After 4 days of study treatment, the patient had bleeding with ulceration in the lower part of the gastrointestinal tract that was recorded as an adverse event with probable relationship to the study device. Endoscopy after the device was removed showed ulceration, but because the patient was not among the first 11 patients recruited into the study, no baseline endoscopy was available for comparison.

Device Performance
Investigators and study coordinators reported that the FMS was easy to insert for 37 (97%) of 38 patients. At the final visit, ease of removal and disposal were not rated for 2 patients who had died, and ease of removal was not rated for 1 additional patient who could not retain the device. For the remaining patients, investigators and study coordinators rated FMS easy to remove for 34 (97%) of 35 patients and easy to dispose of for 36 (100%) of 36 patients.

Caregivers completed a total of 200 daily reports of device performance (Table 4Go). On 83% to 90% of these reports, caregivers said they agreed or strongly agreed with each of the following statements: the device improved fecal incontinence control, and it was practical, caregiver- and patient-friendly, time-efficient, and efficacious. Caregivers also reported that odor and blockage were uncommon (15% and 16%, respectively) and reported changing the collection bag at 26% of daily assessments.


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  		Table 4 Summary of daily caregiver ratings of device performance (N = 200)a

 
Caregivers recorded the extent of leakage on 198 daily assessments; most of these reports (83%) indicated minimal or no leakage (Table 5Go). Of the 39 patients who had evaluations of skin condition at baseline and final visit, 26% had normal skin on the buttocks and 23% had normal skin on the perineum at baseline (Table 6Go). By the final visit, skin condition was improved or maintained on the buttocks for 92% of patients and on the perineum for 92% of patients.


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  		Table 5 Device leakage

 

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  		Table 6 Change in skin condition from baseline to final evaluationa

 
On 130 (65%) of the 200 daily assessments, caregivers reported that patients were nonresponsive. Of the 70 daily caregiver reports that included patients’ assessments of physical symptoms, 52 (26%) indicated that patients did not have discomfort, pain, burning, or irritation. Pain was reported at 8 (4%) assessments and irritation at 1 (<1%). Caregivers categorized 9 responses (4%) from patients as other, including 4 reports (2%) of "urge to defecate."


   Discussion
Top
 Abstract
 Methods
 Results
 Discussion
Conclusion
 References
 
Fecal management is a priority in intensive and acute care. Traditional strategies for management of fecal incontinence, such as the use of bed pads, can be onerous and time-consuming for healthcare professionals. For a patient with diarrhea and fecal incontinence, several linen changes may be required during a single nursing shift to reduce exposure to wetness, feces, and microorganisms.9 Soiling of bed pads may lead to odor and to discomfort and embarrassment for the patient. To avoid these problems, nurses spend a substantial amount of time changing bed linens, an undertaking that interferes with other important tasks. Changing soiled linens and fecal containment products is also complicated by the need to follow contact precautions to prevent transmission of nosocomial infections, particularly those caused by Clostridium difficile,10 which is a frequent cause of diarrhea in hospitalized patients and is more common in severely ill patients than in the general population of hospitalized patients.11


Rectal mucosa was healthy after FMS use for all 8 patients who had baseline and follow-up endoscopy.

 

External fecal incontinence collectors can be applied to perirectal skin to contain stool, but this approach usually requires 2 caregivers to install the device correctly, and removal of the adhesive barrier may damage already fragile skin.12 Another alternative to fecal management with bed linens involves the insertion of tubing (eg, urinary drainage catheters, mushroom catheters, nasal trumpets) into the rectum for stool diversion. Preliminary clinical studies have indicated that these approaches can divert feces effectively,13–15 but a device must be created from parts intended for other uses and the safety of the makeshift devices is not well defined.

In contrast, the FMS was approved specifically for fecal management in patients with little or no bowel control and liquid or semiliquid stool.8 The shape, size, and softness of the rectal balloon of the system were designed to minimize mucosal damage after insertion into the rectum yet allow the device to be retained in the rectum for up to 29 days. Of the 42 patients in our study, 35 were able to retain the FMS until removal, and the device was reinserted successfully for 3 of the 7 patients who expelled it. Thus, most patients were able to retain the FMS. Patients with reduced sphincter tone who cannot retain the balloon may require fecal management with traditional strategies instead of a fecal diversion and collection device.

A major clinical objective of fecal management is to protect skin integrity. Two-thirds of patients in this study had multiple comorbid conditions, and more than three-quarters of patients had abnormal skin of the perineum and buttocks at baseline. Despite the presence of these risk factors for ulceration,9 skin integrity was either maintained or improved in more than 92% of patients during use of the FMS. Only one patient began the study with intact skin and had open skin on the buttocks at the final evaluation. The maintenance or improvement of skin integrity for most patients in this small study may have been related to the ability of the device to divert and collect stool with minimal or no leakage. Exposure of perineal skin to excess wetness and feces increases the risk for perineal dermatitis and ulceration.2,7 By diverting the stool and collecting it in a pouch attached to the catheter, thereby minimizing stool leakage, the FMS also may minimize skin breakdown and associated complications.

Few well-controlled studies have been undertaken to demonstrate the effect of continence aids on skin condition.16 According to a national prevalence and incidence survey of pressure ulcers in acute care settings,17 incidences of new-onset ulcers ranged from 7% to 9% between 1999 and 2004. However, those rates were reported for hospitalized patients overall, whereas more than three-quarters of the patients in our study were from the ICU. In a systematic review2 of 16 prospective studies, the incidence of pressure ulcers was higher in ICU patients (up to 56%) than among all hospitalized patients (up to 22%). Additional controlled studies are required to confirm whether the use of the FMS influences the risk for perineal dermatitis or pressure ulcers in hospitalized patients with fecal incontinence.

Eight patients had endoscopic proctoscopy both before and after use of the FMS, and rectal mucosa was normal at the end of the study in each of these patients. One patient had an admitting diagnosis of gastrointestinal bleeding and was receiving anticoagulant and antiplatelet therapies before use of the FMS. After 4 days of FMS treatment, the patient had gastrointestinal bleeding that the investigator considered probably related to the study device and the patient was dropped from the study. Endoscopy after removal of the device revealed ulceration, but the patient had not had endoscopy before insertion of the FMS, so we could not determine whether FMS use preceded the ulceration. As noted in the prescribing information for FMS, the device should not be used in patients with suspected or confirmed impairment of the rectal mucosa.8

Although performance and safety are key considerations for the evaluation of a new device for fecal management, determining whether achievement of these clinical goals results in undue discomfort or embarrassment for patients is also important. Caregivers reported that the majority of patients who were alert and responsive had no pain or discomfort with an FMS in place. Most of the daily evaluations indicated that the device was patient -friendly and that no odor was present. A comparative study of FMS with traditional fecal management strategies that includes more direct input from patients would be required to confirm the effects of the FMS on patients’ dignity and comfort.


Despite the presence of risk factors for ulceration, skin integrity was either maintained or improved in more than 92% of patients during use of the FMS.

 

Caregivers reported the device was time-efficient, practical, and caregiver-friendly, and they reported changing FMS collection bags on only 1 in 4 study days. Investigators and study coordinators reported that all of the device disposals and almost all of the device insertions and removals were easy. We did not evaluate economic outcomes in this study, but fecal incontinence can be costly to manage not only because of the direct costs of nursing time and supplies but also because of the indirect costs associated with pressure ulcers and nosocomial infections.5,18,19 Prospective, well-controlled trials are required to analyze the comparative cost-benefit of FMS and other fecal management strategies.

The subjective assessments of skin condition and the lack of a control group in this study limit the conclusions that can be drawn about a direct effect of the FMS on skin condition. Caregivers were not evaluated for interrater reliability on their use of the skin condition assessment scale, and the scale itself was not validated, but even established instruments for the evaluation of pressure ulcers are subject to variance in interpretation.20


This device adds an important option for the management of diarrhea and fecal incontinence in hospitalized patients.

 


   Conclusion
Top
 Abstract
 Methods
 Results
 Discussion
 Conclusion
References
 
This prospective, noncontrolled, descriptive clinical study provided evidence of the safety, performance, and ease of use of the FMS in hospitalized patients with diarrhea and fecal incontinence. Comparison of the findings of endoscopic proctoscopy before and after use of the device revealed no adverse effect of the FMS on rectal mucosa. Most patients were able to retain the device until removal. One patient who had gastrointestinal bleeding at the time of entry into the study had gastrointestinal bleeding and ulceration during the study. The use of the FMS in patients with suspected or confirmed impairment of the rectal mucosa is not recommended.

Caregivers from both ICUs and acute care units reported that the FMS improved control of fecal incontinence with minimal leakage and was practical, efficacious, time-efficient, and caregiver- and patient-friendly. Patients’ reports of pain and discomfort with the device were uncommon. Investigators and study coordinators reported that the FMS was easy to insert and easy to remove for almost all of the patients. This device adds an important option for the management of diarrhea and fecal incontinence in hospitalized patients. Additional well-designed, controlled clinical trials may help measure the clinical and economic outcomes associated with the use of the FMS device.


   ACKNOWLEDGMENTS
 
Jo Ann Ottino, MA, provided assistance with statistical analyses. Donalyn Hyland, RN, and Jonathan N. Latham, PharmD, provided editorial assistance on behalf of Conva-Tec. The Flexi-Seal Clinical Trial Investigators Group included the following centers, listed alphabetically by state. Institution/investigator/study coordinator: (1) Maricopa Medical Center, Phoenix, Arizona/Kevin Foster, MD/Karen Richey, RN, CRC; (2) Stamford Hospital, Stamford, Connecticut/James Krinsley, MD/Patricia Parry, RN, CCRC; (3) Shands Hospital at the University of Florida, Gainesville/T. James Gallagher, MD/Judith Wishin, RN, BSN, CCRC; (4) Atlanta Academic Research Group, Decatur, Georgia/Mark Stern, MD, and Jeff Williams, MD/none; (5) Jersey Shore University Medical Center, Neptune, New Jersey/Kathleen Casey, MD/Mary DeSane, RN, BSN, CCRN; (6) Mt Carmel Health System, Columbus, Ohio/Anantha Padmanabhan, MD/Mary Merrill, RN, MS, CNP, CWOCN; (7) Forum Health, Youngstown, Ohio/Salim Abou Jaoude, MD/Mari Mangino, RN, CCRC, andToni Lackey, RN, BSN, CWOCN.

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FINANCIAL DISCLOSURE
This study was supported by a grant from ConvaTec, a Division of E. R. Squibb & Sons, LLC.


   REFERENCES
Top
 Abstract
 Methods
 Results
 Discussion
 Conclusion
 References
 

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