Safety of Magnetic Resonance Imaging in patients under Sacral Neuromodulation with an InterStim Neuromodulator

Karrer-Warzinek, Elisabeth; Abt, Dominik; Kim, Olaf Chan-Hi; Schmid, Hans‐Peter; Engeler, Daniel S.; Müllhaupt, Gautier

doi:10.1016/j.urology.2021.03.013

Cited by 2 publications

(2 citation statements)

References 15 publications

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“…It is estimated that a large percentage of patients receiving neuromodulation therapy will require an MRI‎ 15 . While the safety of off‐label noncranial MRI in previous devices that were implanted but turned off has been reported‎, 16 this has had relatively little impact on the availability of non‐cranial MRI to those patients given product labeling and the unwillingness of imaging centers to assume perceived liability. It is therefore worth noting that in this study, by the 6‐month mark, 7.4% of patients had already required an MRI, with 80% of those being noncranial studies.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of clinical performance and safety for the rechargeable InterStim Micro device in overactive bladder subjects: 6‐month results from the global postmarket ELITE study

Goudelocke

Xavier

Pecha

et al. 2023

Neurourology and Urodynamics

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Aims: Sacral neuromodulation (SNM) is an advanced therapy option for the treatment of overactive bladder (OAB), nonobstructive urinary retention, and fecal incontinence. The aim of this ongoing prospective, multicenter, global, postmarket study is to confirm safety and clinical performance of the InterStim TM Micro system for SNM in all indications. Reported here are the results for the OAB cohort through 6-month follow-up.Methods: Eligible OAB subjects that had a successful therapy evaluation were enrolled after implant of an InterStim Micro implantable pulse generator (IPG).Subjects completed voiding diaries and the Overactive Bladder Quality of Life questionnaire (OAB-q) at baseline and follow-up visits occurring at 3 months and 6 months postimplant. Safety was evaluated as device-, procedure-, or therapyrelated adverse events. The primary objective for the OAB cohort was to demonstrate an improvement in OAB-q Health Related Quality of Life (HRQL) total score at 3 months postimplant compared to baseline. Results: Sixty-eight OAB subjects were enrolled and implanted with an InterStim Micro IPG. Of those, 67 and 66 subjects completed the 3-and 6-month follow-up visits, respectively. The OAB-q HRQL demonstrated a statistically significant improvement from baseline to 3-month follow-up with an average increase of 33 ± 24 points (n = 67, p < 0.001). The change was also observed at 6-months with an average increase of 31 ± 23 points (n = 65) compared to baseline. Eighty-two percent of subjects achieved the minimally important difference in HRQL score at 3-and 6-month, respectively, with a change of 10 points or greater. The majority of subjects reported that their bladder condition was better at 3-month (92.5%, 62/67) and 6-month (89%, 59/

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Section: Discussionmentioning

confidence: 99%

Evaluation of clinical performance and safety for the rechargeable InterStim Micro device in overactive bladder subjects: 6‐month results from the global postmarket ELITE study

Goudelocke

Xavier

Pecha

et al. 2023

Neurourology and Urodynamics

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“…Both Medtronic and Axonics have produced rechargeable generators for SNM with approximate 15-year lifetimes, although the recharging process increases the burden of device maintenance ( 54 ). SNM was historically a contraindication for magnetic resonance imaging (MRI), however, the MRI-compatible InterStim sacral neuromodulator developed by Medtronic has been shown safe even for lumbosacral imaging ( 55 ).…”

Section: Snmmentioning

confidence: 99%

The urologist’s role in bowel management of adult spina bifida: a narrative review

Sundell,

Koch,

Kaufman

2024

Transl Androl Urol

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Background and Objective Urologists are central to the coordinated care of patients with spina bifida (SB), and efforts to optimize bladder management and protection of the upper tracts are well established. However, the urologist’s role in treating this population often extends to the management of bowel dysfunction which may be less defined. The methods available to the urologist for bowel management range from lifestyle modifications to medical and surgical therapy, with many patients requiring combinations of multiple strategies to combat conflicting symptoms of constipation and fecal incontinence (FI). This narrative review aims to compile a detailed algorithm of management options, for the practicing urologist to more confidently address this important facet of care. Methods A detailed review was conducted using PubMed and Google Scholar databases to assess the contemporary literature surrounding neurogenic bowel dysfunction in adult SB. Articles published in English between 1990 and 2023 were considered. Key Content and Findings This review presents and investigates a schema of increasingly definitive and invasive treatments for bowel dysfunction including lifestyle adaptations, pharmacological treatment, transanal irrigation (TAI), sacral neuromodulation (SNM), antegrade continence procedures, and bowel diversion. TAI and medical bowel care are beneficial in postponing or avoiding more invasive surgical interventions. Should conservative measures prove ineffective, surgical management provides the most definitive bowel control. Conclusions Symptoms of constipation and FI that result from neurogenic bowel are best managed with an individualized approach guided by the general treatment algorithm presented in this review. Educated on the numerous appropriate options, patients will often trial methods before proceeding with more invasive treatments. Additional work is required to further evaluate management options specific to the SB populations, especially in more contemporary and largely experimental treatment modalities such as SNM.

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Safety of Magnetic Resonance Imaging in patients under Sacral Neuromodulation with an InterStim Neuromodulator

Cited by 2 publications

References 15 publications

Evaluation of clinical performance and safety for the rechargeable InterStim Micro device in overactive bladder subjects: 6‐month results from the global postmarket ELITE study

Evaluation of clinical performance and safety for the rechargeable InterStim Micro device in overactive bladder subjects: 6‐month results from the global postmarket ELITE study

The urologist’s role in bowel management of adult spina bifida: a narrative review

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