Retrospective Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Radiol. Feb 28, 2024; 16(2): 32-39
Published online Feb 28, 2024. doi: 10.4329/wjr.v16.i2.32
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
ARTICLE HIGHLIGHTS
Research background

Fecal incontinence is a disease condition with significant morbidity and social stigmata. Many modalities are used in its treatment and sacral nerve stimulation, lately has been widely accepted as the second line treatment, after the conservative measures fail. Sacral nerve stimulation has been shown to be beneficial in short and long term studies. However, one limitation of its use in the past was concurrent use with magnetic resonance imaging (MRI), which was considered unsafe if used for MRI below the head. Almost 23% of the removals of implants was because the patient required MRI. For this reason, multiple tests and innovation was done and a newer tined lead was developed which was safe to be used with MRI under specific settings. This was United States Food and Drug Administration approved for use in 2020. Our study is to evaluate the efficacy and outcomes of using this recently available treatment modality in fecal incontinence.

Research motivation

Main topics we are trying to deal with are: (1) Does the currently available tined lead (InterStim), which is safe to use in MRI, reciprocate the outcomes and efficacy to the previously available tined lead (InterStim); (2) Any new challenges were faced related to the currently available tined lead. The study is important as this would definitely help us take a leap forward in the management of fecal incontinence. If the outcomes are similar to the previously available system, this will give more confidence to the providers and also will provide benefits to patients.

Research objectives

The objective of this study was to evaluate whether the currently available MRI compatible sacral nerve stimulation system is as efficacious and as safe as the previously available system. At least in the short term, the efficacy is good with a similar safety profile. However, future research including longer follow up results from the current study and future studies with a larger sample size will be needed to further substantiate the findings.

Research methods

This was a retrospective analysis of prospectively collected data from multiple institutions. SPSS 20 was used for data analysis. Descriptive statistics were done including frequencies, percentages, and means were calculated from the data.

Research results

The mean age was 63 years old. There were concomitant symptoms of diarrhea in 23%, fecal urgency in 58.9% and urinary incontinence in 28.5% of the patients. Patients either underwent peripheral nerve stimulation (PNE) or stage 1 as the first procedure followed by stage 2 of implant placement. 15 (20.5%) patients underwent PNE before proceeding to a permanent implant. One important adverse event noted was an external lead connection migration, which was seen in 7 (9.6%) patients after stage 1 procedure. One patient required explantation due to infection, 7 (9.6%) patients had complications which were nerve pain, hematoma, infection, lead fracture and bleeding. Mean follow up was 6.62 months and 93.2% patients reported significant improvement of symptoms. These findings at least in the short term are efficacious and safe as the preciously available system, however, long term data and future studies with increased power are needed.

Research conclusions

A new theory that this study proposes is that the newer tined lead (InterStim) for treatment of fecal incontinence is as efficacious and has similar safety profiles as compared to the previously available system.

Research perspectives

The direction of the future research should be towards conducting more high powered studies, including evaluating the newer system with the MRI usage to see whether the safety with the MRI can be substantiated.