Managing diarrhea and fecal incontinence: results of a prospective clinical study in the intensive care unit

Introduction

Managing fecal incontinence and diarrhea challenges ICU staff to control the fecal output and to protect the skin. This diverts resources from other vital patient needs. A new medical device system (FMS) was developed in which an inflated balloon retains a tube within the rectum while an external pouch collects fecal material, offering an option for temporary continence in subjects with uncontrolled diarrhea.

Hypothesis

Safety and performance of an innovative system (FMS) for managing fecal incontinence was evaluated in a prospective non-comparative study in two ICUs.

Methods

Ten subjects with diarrhea and incontinence in two ICUs had the FMS inserted. Endoscopic proctoscopies of the rectal vault assessed the condition of the anorectal mucosa pre-insertion and post-removal. Investigators assessed ease of FMS insertion and removal, device retention and leakage, patient comfort, perineal skin condition and presence or absence of odor during FMS use.

Results

The FMS device performed well during use for 1–13 days with no safety issues among any of the 10 subjects, although two died during the study due to non-product-related illnesses. It was judged easy to insert and to remove with easy-to-follow instructions. All subjects retained the device without difficulty or external securing devices for the duration of the study, except one with a weakened internal sphincter who expelled it after 8 hours. During a total of 65 daily assessments, nurses reported the FMS effective and time efficient in managing fecal incontinence, with no odor or discomfort reported and limited leakage. During FMS use, perineal and buttock skin condition was maintained or improved in all but one patient who developed patchy redness on the buttocks.

Conclusions

The FMS was well accepted, performed well, with no safety issues, for all patients and helped reduce the risk of perineal and buttock skin breakdown.