Exhausted implanted pulse generator in sacral nerve stimulation for faecal incontinence: What next in daily practice for patients?
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The efficacy of sacral nerve stimulation in faecal incontinence relies on an implanted pulse generator known to have a limited lifespan. The long-term use of sacral nerve stimulation raises concerns about the true lifespan of generators. The aim of the study was to assess the lifespan of sacral nerve stimulation implanted pulse generators in daily practice, and the outcome of exhausted generator replacement, in faecal incontinent patients.
Faecal incontinent patients with pulse generators (Medtronic Interstim™ or InterstimII™) implanted in a single centre from 2001 to 2014 were prospectively followed up. Generator lifespan was measured according to the Kaplan-Meier method. Patients with a generator explanted/turned off before exhaustion were excluded. Morbidity of exhausted generator replacement and the outcome (Cleveland Clinic Florida Faecal Incontinence (CCF-FI) and Faecal Incontinence Quality of Life (FIQL) scores) were recorded.
Of 135 patients with an implanted pulse generator, 112 (InterstimII™ 66) were included. Mean follow-up was 4.9 ± 2.8 years. The generator reached exhaustion in 29 (26 %) cases. Overall median lifespan of an implanted pulse generator was approximately 9 years (95 % CI 8–9.2). Interstim™ and InterstimII™ 25th percentile lifespan was 7.2 (CI 6.4–8.3) and 5 (CI 4–not reached) years, respectively. After exhaustion, generators were replaced, left in place or explanted in 23, 2 and 4 patients, respectively. Generator replacement was virtually uneventful. CCF-FI/FIQL scores remained unchanged after generator replacement (CCF-FI 8 ± 2 vs 7 ± 3; FIQL 3 ± 0.6 vs 3 ± 0.5; p = ns).
In this study, the implanted pulse generator observed median lifespan was 9 years. After exhaustion, generators were safely and efficiently replaced. The study also gives insight into long-term needs and costs of sacral nerve stimulation (SNS) therapy.
KeywordsSacral nerve stimulation Implanted pulse generator Battery exhaustion Faecal incontinence Outcome
The authors are grateful to Mrs Nelly Rondeau-Moreau for her participation in the acquisition of the data and to Mr Andrew Spiers for his critical comments.
Compliance with ethical standards
The study was supported in part by the “Centre d’études et de recherches en chirurgie” (CEREC) of the University Hospital of Nantes.
Conflict of interest
Paul-Antoine Lehur has received honoraria from Medtronic as a speaker at meetings.
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