title: Exhausted implanted pulse generator in sacral nerve stimulation for faecal incontinence: What next in daily practice for patients?
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Clinique de Chirurgie Digestive et Endocrinienne, Institut des Maladies de l'Appareil Digestif, University Hospital of Nantes, Nantes, France. emilie.dassonneville@chu-nantes.fr.
authors.forename: Emilie
authors.initials: E
authors.lastname: Duchalais
authors.affiliation: Clinique de Chirurgie Digestive et Endocrinienne, Institut des Maladies de l'Appareil Digestif, University Hospital of Nantes, Nantes, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Meurette
authors.affiliation: EA4275-SPHERE "Biostatistics, Pharmacoepidemiology and Subjective Measures in Health Sciences", University of Nantes, Nantes, France.
authors.forename: Bastien
authors.initials: B
authors.lastname: Perrot
authors.affiliation: Clinique de Chirurgie Digestive et Endocrinienne, Institut des Maladies de l'Appareil Digestif, University Hospital of Nantes, Nantes, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Wyart
authors.affiliation: Clinique de Chirurgie Digestive et Endocrinienne, Institut des Maladies de l'Appareil Digestif, University Hospital of Nantes, Nantes, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Kubis
authors.affiliation: Clinique de Chirurgie Digestive et Endocrinienne, Institut des Maladies de l'Appareil Digestif, University Hospital of Nantes, Nantes, France.
authors.forename: Paul-Antoine
authors.initials: PA
authors.lastname: Lehur
mesh_terms: D003362:Cost-Benefit Analysis; D004599:Electric Stimulation Therapy / Q000191:economics / Q000295:instrumentation*; D004567:Electrodes, Implanted; D004868:Equipment Failure; D005242:Fecal Incontinence / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D012447:Sacrum / Q000294:innervation*; D013127:Spinal Nerves; D013997:Time Factors
keywords: Battery exhaustion; Faecal incontinence; Implanted pulse generator; Outcome; Sacral nerve stimulation