Clinical Evaluation of a Novel Intrarectal Device for Management of Fecal Incontinence in Bedridden Patients

Purpose The primary objective of the study was to evaluate the safety and efficacy of a stool management kit (SMK) for containment of fecal incontinence in hospitalized bedridden patients. Design A single-group quasi-experimental study. Subjects and setting Twenty bedridden adults who had at least 1 episode of fecal incontinence in the prior 24 hours participated in the study. The study setting was the neurological unit of the All India Institute of Medical Sciences in New Delhi, India. Methods The study was carried out in 2 phases. The device was placed in situ for up to 24 hours in 10 patients during phase I of the study and up to 120 hours in an additional 10 patients during phase II. Participants were assessed for anorectal injury and peripheral device leakage on a 4- to 6-hourly basis. Sigmoidoscopy was performed to evaluate for any mucosal trauma or alteration of anorectal pathology after retrieval of the device. Results The device was successfully placed in all patients following the first attempt to place the device; 80% of patients retained the device until planned removal. The SMK diverted fecal matter without anal leakage in 174 (93.5%) out of 186 assessment points in a group of 20 patients. The devices remained in situ for 21 ± 0.2 and 84.5 ± 38.9 hours during phase I and phase II, respectively. None experienced anorectal bleeding, sphincter injury, or mucosal ulceration with device usage. Post-device sigmoidoscopy revealed erythema at the site of diverter placement in 2 participants. Conclusion Study findings suggest that the SMK successfully diverted liquid to semiformed fecal exudate without peripheral device leakage in 93.5% of bedridden patients. No serious adverse events occurred. Additional research is needed to compare its effectiveness with that of currently available intrarectal balloon devices.