Results of this study suggest the use of FMS in immobile patients is a safe way to contain and effectively divert effluent away from wounds with the hope of keeping them free from fecal contamination and to contain effluent in patients experiencing the disabling effects of diarrhea. The safety of using intrarectal catheters to manage fecal incontinence in hospitalized patients has been previously reported in prospective studies1,2,10 and is supported by the findings of this paper. Table 4A and 4B provides a summary of the studies cited in this paper.
The mean age of the patients was 63 years (range 21–90), suggesting the FMS is effective across most adult ages. The relationship between age and developing anal atony and spontaneous tube expulsion was examined and no significant association was found. Further, the mean age of the patients was similar to that of another study10 where the mean age was 60.7 years; however, in that study diarrhea was the only indication for use.
In this study, the FMS was used for a mean of 17.4 (range 1–74) days. Two other studies report mean duration of use as 14 and 35 days, respectively.1,2 Cost effectiveness increases with length of use,7 highlighting the importance of comprehensive pre-insertion patient assessment and education of the staff caring for these patients.
There were no complaints by patients of discomfort caused by the device documented in the records. This supports other studies that found most patients experienced no pain or discomfort when the FMS was in situ.2,10 The findings in the current study are consistent with reports determining sedation is not required for insertion of the FMS.2
No incidents of fistulae, fissures, ulceration, or other adverse events were found to be related to the FMS in this study; however, research includes cases of anal/rectal ulceration with both FMS and BMS.1,8 One case report of an anovaginal fistula was presumed to have resulted from a FMS.12
Overinflation of the retention balloon was the most common problem identified in this study. Nurses unfamiliar with the FMS had attempted to irrigate the tube via the balloon port. Increased education and supervision in non-ICU areas and “capping” the balloon port have been introduced to prevent accidental overinflation of the retention balloon. The balloon port has a “male” connector that is compatible with a “female” intravenous cannula cap. Capping the balloon port adds an extra step for nurses and encourages them to think and look closely at the port to ensure routine flushing is instilled via the irrigation port and not inadvertently into the retention balloon. In the authors’ facility, as part of policy and protocol, retention balloon pressure is now routinely checked weekly, and more frequent checking is initiated if effluent leak around the device is excessive. For safety, research2,3 recommends the device be checked for patency every 8 hours and the retention balloon volume checked weekly.
During the time taken to finalize this study, the study product underwent enhancement; a new product (Flexi-Seal® Signal, ConvaTec) addresses some of the complications encountered in this study. The most noticeable of the product enhancements is the introduction of a signal “pop up” indicator on the retention balloon port indicating when an appropriate volume of fluid has been inserted. Evaluation of this change is required to assess its success. Other complications that may occur include perforation, fistula formation, obstruction, ulceration, and bleeding1,8,9; however, none of these were identified in this study.
Disposable proctoscopes were used by the colorectal Fellows to inspect the rectal mucosa when retention balloon over inflation occurred; no associated mucosal injury was identified. Other studies2,8,10 have reported inspecting the rectal mucosa by proctoscopy following FMS removal and revealing healthy rectal mucosa; however, the authors of those studies acknowledged this was done following normal use and not specifically following balloon overinflation or inadvertent expulsion. Although 14% of patients in this study had an overinflated retention balloon at some point, no mucosal necrosis was reported and any anal atony resolved shortly after the device was removed.
The occurrence of leaks around the device can be minimized by ensuring modification of the stool before FMS insertion by using an appropriate aperient (ie, medicine that facilitates evacuation and addresses obstruction) tailored to each patient based on stool consistency and regular flushing with small volumes of water (50–100 mL) post-insertion. An appropriate aperient regimen should continue in patients where the FMS was inserted for a reason other than diarrhea, and frequent checking of the tube for position and kinking is recommended.5 Small leaks are to be expected9; however, more voluminous leaks may be due to the tube twisting causing occlusion, the stool becoming too thick to drain freely, or poor sphincter tone that can prevent the creation of an adequate seal. In a prospective, single-arm clinical study (N = 42),10 83% of persons with a BMS experienced minimal or no leakage of stool, compared to 96% in this study.
A slight leak of stool around the FMS can be managed with a zinc barrier cream and incontinence pads. At the time of insertion, the black line around the FMS tube should be visible outside the anus; this can be used as a reference point to assess whether the FMS has passed too far into the rectum. If this occurs, balloon pressure should be checked and the FMS gently pulled down to recreate the seal against the rectal floor. Further, the patient’s bed can be positioned with feet angled slightly down to enable gravity to assist in draining the FMS.
In this study, anal sphincter atony became more evident the longer the FMS was in place. Poor sphincter tone led to more frequent FMS expulsion (P = 0.003) and reinsertion. The FMS can be reinserted if it has been used <29 days. In this study, 28% of patients experienced spontaneous tube expulsion and this increased with duration of time the FMS remained in situ. Additionally, it is believed FMS expulsion is linked to inadequate use of aperients to loosen stool consistency in order to assist the flow of effluent through the device, particularly in patients where diarrhea is not the reason for insertion.
A multicenter, observational study8 conducted at 12 US sites (N = 146) reported 21.4% of patients experienced spontaneous device expulsion. In a small prospective study,1 25% of patients experienced anal atony with the duration of use of a BMS being between 25 and 74 days (the BMS was removed and a new system inserted if required for >29 days). The US Food and Drug Administration9 approved BMS/FMS for continuous use for up to 29 days. The FMS has been listed on the Australian Register of Therapeutic Goods (ARTG); its Instructions for Use are part of the technical documentation and state that the maximum wear time of the device is 29 days.11
A small prospective study1 also reported a colostomy was required in patients who were unable to retain the BMS. However, despite the length of time the FMS was in situ and in contrast with these results, none of the patients in the current study went on to require a defunctioning stoma. Rather, the findings of this study were similar to those of Padmanabhan et al,10 where the majority of patients were able to retain their FMS until it was assessed as no longer required.
The findings of the current study also support results of a review4 of the evidence in which patients reported a rapid return of normal bowel function following removal of the BMS when the device had been in for a minimum of 30 days.