Early clinical experience with a novel automated fecal management system for fecal incontinence in high-risk oncology and intensive care unit patients: a retrospective analysis and structured narrative literature review.
- 1Independent Researcher, Tucson, AZ, United States.
- 2Independent Researcher, Cuyahoga Falls, OH, United States.
Abstract
Background
Fecal incontinence (FI) is prevalent in critically ill oncology patients, frequently compounded by chemotherapy-induced diarrhea (CID) and severe thrombocytopenia. Conventional indwelling balloon catheters (IBCs), the standard approach to FI management in the ICU, generate intraluminal radial pressures that frequently exceed mucosal capillary perfusion thresholds and are formally contraindicated by manufacturers in patients with platelet counts below 50 x 10⁹/L. This retrospective analysis and structured narrative literature review evaluates the safety, fecal containment efficacy, and nursing workload impact of a novel pressure-free automated stool management (ASM) system in high-risk oncology ICU patients.Methods
A retrospective analysis was conducted at a major academic comprehensive cancer center in the United States during 2025. Outcome data from 190 unique adult oncology ICU patients, including two structured evaluation cohorts of 20 patients each, followed by broader institutional implementation (n=150), were compiled from standardized nursing quality improvement product evaluation forms completed throughout each patient's device-use period. A prospectively designated thrombocytopenic subgroup (n=47; platelet counts <50 x 10⁹/L at device deployment) was analyzed separately. A structured narrative literature review was conducted across PubMed, MEDLINE, and CINAHL (final search: February 2026).Results
Across 190 unique device placements, zero device-related adverse events were observed (adverse event rate 0%; 95% CI upper bound 1.6%, rule of three). In the thrombocytopenic subgroup (n=47), zero device-related adverse events were observed (95% CI upper bound 6.4%). No device-related mucosal bleeding, perforation, ulceration, necrosis, or device malfunction requiring intervention was documented. The device achieved 100% successful fecal diversion, with no major leakage event (defined as stool output requiring linen replacement) recorded. The per-assessment leakage rate was 1.7% (11 positive assessments out of 646 total), all representing minor peripheral moisture requiring only topical hygiene management with no linen change. Daily nursing time with ASM was 6.8 minutes per patient per day; contextual comparison with published estimates of 120 minutes per patient per day (IBC protocol) and 174 minutes per patient per day (absorbent pad management) from Vargo et al. yields estimated differences of 94% and 96%, respectively, subject to methodological differences between datasets. Retrospective chart review identified no chemotherapy delays or ICU length of stay prolongation attributable to device-related complications.Conclusions
This early institutional experience with a novel pressure-free ASM across 190 unique oncology ICU placements, including 47 in patients with severe thrombocytopenia, was not associated with any observed device-related adverse event. These findings represent hypothesis-generating preliminary data and do not establish superiority over conventional devices. The clinical need for safe fecal management alternatives in thrombocytopenic oncology patients is substantive; these data provide rationale for appropriately powered prospective comparative trials.
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BibTeX
@article{kennedyevans2026early,
title = {{Early clinical experience with a novel automated fecal management system for fecal incontinence in high-risk oncology and intensive care unit patients: a retrospective analysis and structured narrative literature review.}},
author = {Karen Lou Kennedy-Evans and Deanna Vargo},
journal = {Frontiers in oncology},
year = {2026},
month = oct,
doi = {10.3389/fonc.2026.1895799},
url = {https://europepmc.org/article/MED/42909232},
note = {CC BY},
}
RIS
TY - JOUR
TI - Early clinical experience with a novel automated fecal management system for fecal incontinence in high-risk oncology and intensive care unit patients: a retrospective analysis and structured narrative literature review.
AU - Karen Lou Kennedy-Evans
AU - Deanna Vargo
PY - 2026
DA - 2026/10/07
JO - Frontiers in oncology
DO - 10.3389/fonc.2026.1895799
UR - https://europepmc.org/article/MED/42909232
AB - Background Fecal incontinence (FI) is prevalent in critically ill oncology patients, frequently compounded by chemotherapy-induced diarrhea (CID) and severe thrombocytopenia. Conventional indwelling balloon catheters (IBCs), the standard approach to FI management in the ICU, generate intraluminal radial pressures that frequently exceed mucosal capillary perfusion thresholds and are formally contraindicated by manufacturers in patients with platelet counts below 50 x 10⁹/L. This retrospective analysis and structured narrative literature review evaluates the safety, fecal containment efficacy, and nursing workload impact of a novel pressure-free automated stool management (ASM) system in high-risk oncology ICU patients.Methods A retrospective analysis was conducted at a major academic comprehensive cancer center in the United States during 2025. Outcome data from 190 unique adult oncology ICU patients, including two structured evaluation cohorts of 20 patients each, followed by broader institutional implementation (n=150), were compiled from standardized nursing quality improvement product evaluation forms completed throughout each patient's device-use period. A prospectively designated thrombocytopenic subgroup (n=47; platelet counts <50 x 10⁹/L at device deployment) was analyzed separately. A structured narrative literature review was conducted across PubMed, MEDLINE, and CINAHL (final search: February 2026).Results Across 190 unique device placements, zero device-related adverse events were observed (adverse event rate 0%; 95% CI upper bound 1.6%, rule of three). In the thrombocytopenic subgroup (n=47), zero device-related adverse events were observed (95% CI upper bound 6.4%). No device-related mucosal bleeding, perforation, ulceration, necrosis, or device malfunction requiring intervention was documented. The device achieved 100% successful fecal diversion, with no major leakage event (defined as stool output requiring linen replacement) recorded. The per-assessment leakage rate was 1.7% (11 positive assessments out of 646 total), all representing minor peripheral moisture requiring only topical hygiene management with no linen change. Daily nursing time with ASM was 6.8 minutes per patient per day; contextual comparison with published estimates of 120 minutes per patient per day (IBC protocol) and 174 minutes per patient per day (absorbent pad management) from Vargo et al. yields estimated differences of 94% and 96%, respectively, subject to methodological differences between datasets. Retrospective chart review identified no chemotherapy delays or ICU length of stay prolongation attributable to device-related complications.Conclusions This early institutional experience with a novel pressure-free ASM across 190 unique oncology ICU placements, including 47 in patients with severe thrombocytopenia, was not associated with any observed device-related adverse event. These findings represent hypothesis-generating preliminary data and do not establish superiority over conventional devices. The clinical need for safe fecal management alternatives in thrombocytopenic oncology patients is substantive; these data provide rationale for appropriately powered prospective comparative trials.
SN - 2234-943X
ER -