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©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
Outcomes and efficacy of magnetic resonance imaging-compatible sacral nerve stimulator for management of fecal incontinence: A multi-institutional study
Binit Katuwal, Amy Thorsen, Kunal Kochar, Ryba Bhullar, Ray King, Ernesto Raul Drelichman, Vijay K Mittal, Jasneet Singh Bhullar
Binit Katuwal, Department of Surgery, Ascension Providence Hospital, Michigan State University College of Human Medicine, Southfield, MI 48075, United States
Amy Thorsen, Department of Colon and Rectal surgery, Alina Health Abbott Northwestern Hospital, Minneapolis, MN 55407, United States
Kunal Kochar, Colon and Rectal Surgery, Advocate Illinois Masonic, Park Ridge, IL 60068, United States
Ryba Bhullar, Volunteer Student, Department of Research, Ascension Providence Hospital, Southfield, MI 48075, United States
Ray King, Colon and Rectal Surgery, University of Wisconsin, Madison, WI 53715, United States
Ernesto Raul Drelichman, Jasneet Singh Bhullar, General and Colorectal Surgery, Ascension Providence Hospital, Michigan State University College of Human Medicine, Southfield, MI 48075, United States
Vijay K Mittal, Department of Surgery, Department of Medical Education, Ascension Providence Hospital, Michigan State University College of Human Medicine, Southfield, MI 48075, United States
Author contributions: Katuwal B, Bhullar JS contributed equally to the design, analysis, and manuscript preparation; Thorsen A, King R, Kochar K, and Drelichman E contributed equally to data acquisition and manuscript writing; Bhullar R, and Mittal V contributed to the manuscript writing and data analysis portion of the study; All authors have read and approved the final manuscript.
Institutional review board statement: The study was exempted by the Institutional Review Board at Providence Hospital. No patient identifiers were used for the data acquisition or analysis.
Informed consent statement: Consent was not needed as the study was retrospective without exposure to the patients’ data.
Conflict-of-interest statement: No conflict of interest noted for any authors at the time of the study. This study was presented at the American Society of Colon and Rectal Surgeons Conference held in Tampa, Florida in 2022 and was published as an abstract. This study was also presented at the Fecal Incontinence and Obstructed Defecation Conference in 2022 which was held in Rome, Italy.
Data sharing statement: The dataset was made available from the corresponding author. This was retrospective data, so consent was waived. The presented data are anonymized and risk of identification is low.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
https://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Jasneet Singh Bhullar, FACS, FASCRS, Doctor, Staff Physician, Department of General and Colorectal surgery, Ascension Providence Hospital, Michigan State University College of Human Medicine, Southfield, MI 48075, United States.
drjsbhullar@gmail.com
Received: September 23, 2023
Peer-review started: September 23, 2023
First decision: November 13, 2023
Revised: November 24, 2023
Accepted: February 2, 2024
Article in press: February 2, 2024
Published online: February 28, 2024
Processing time: 152 Days and 16 Hours
BACKGROUND
Fecal incontinence (FI) is an involuntary passage of fecal matter which can have a significant impact on a patient’s quality of life. Many modalities of treatment exist for FI. Sacral nerve stimulation is a well-established treatment for FI. Given the increased need of magnetic resonance imaging (MRI) for diagnostics, the InterStim which was previously used in sacral nerve stimulation was limited by MRI incompatibility. Medtronic MRI-compatible InterStim was approved by the United States Food and Drug Administration in August 2020 and has been widely used.
AIM
To evaluate the efficacy, outcomes and complications of the MRI-compatible InterStim.
METHODS
Data of patients who underwent MRI-compatible Medtronic InterStim placement at UPMC Williamsport, University of Minnesota, Advocate Lutheran General Hospital, and University of Wisconsin-Madison was pooled and analyzed. Patient demographics, clinical features, surgical techniques, complications, and outcomes were analyzed. Strengthening the Reporting of Observational studies in Epidemiology(STROBE) cross-sectional reporting guidelines were used.
RESULTS
Seventy-three patients had the InterStim implanted. The mean age was 63.29 ± 12.2 years. Fifty-seven (78.1%) patients were females and forty-two (57.5%) patients had diabetes. In addition to incontinence, overlapping symptoms included diarrhea (23.3%), fecal urgency (58.9%), and urinary incontinence (28.8%). Fifteen (20.5%) patients underwent Peripheral Nerve Evaluation before proceeding to definite implant placement. Thirty-two (43.8%) patients underwent rechargeable InterStim placement. Three (4.1%) patients needed removal of the implant. Migration of the external lead connection was observed in 7 (9.6%) patients after the stage I procedure. The explanation for one patient was due to infection. Seven (9.6%) patients had other complications like nerve pain, hematoma, infection, lead fracture, and bleeding. The mean follow-up was 6.62 ± 3.5 mo. Sixty-eight (93.2%) patients reported significant improvement of symptoms on follow-up evaluation.
CONCLUSION
This study shows promising results with significant symptom improvement, good efficacy and good patient outcomes with low complication rates while using MRI compatible InterStim for FI. Further long-term follow-up and future studies with a larger patient population is recommended.
Core Tip: The advent of newer technology has improved the outcome of various diseases including FI. However, not all patients were able to get full access to this technology in part because of lack of adequate technology available. Moreover, the patients had to endure unwanted surgeries, especially ex-plantation of the stimulators in case magnetic resonance imaging (MRI) was needed. The introduction of a safe MRI-compatible sacral nerve stimulator has solved this problem. The MRI-compatibility is noted to be safe in specific MRI settings. The patients are benefited and the technology seems to besimilar to the previous technology available, however with this added benefit.
