• Neuromodulation · Oct 2018

    Long-Term Outcome Following Implanted Pulse Generator Change in Patients Treated With Sacral Nerve Modulation for Fecal Incontinence.

    • Adrien Le Fouler, Emilie Duchalais, Tse-Han Loong, Corine Baayen, Vincent Wyart, Caroline Kubis, Guillaume Meurette, and Paul-Antoine Lehur.
    • Clinique de Chirurgie Digestive et Endocrinienne, Institut des Maladies de l'Appareil Digestif, University Hospital of Nantes, Nantes, France.
    • Neuromodulation. 2018 Oct 1; 21 (7): 694-699.

    BackgroundLong-term outcome of sacral nerve modulation (SNM) patients after implanted pulse generator (IPG) change for fecal incontinence (FI) is unknown. This study reported the outcome and long-term satisfaction after a change of an exhausted IPG, questioning the need to concurrently change the electrode and looking for factors involved in the maintenance of treatment efficiency.MethodsPatients with fecal incontinence and with a Medtronic IPG implanted in a single center (2001-2016) were prospectively followed up. Satisfaction was graded according to a patient-reported outcome measure from 0 to 10. A pre- and postreplacement FI severity score (Cleveland Clinic Fecal Incontinence Score) and Fecal Incontinence Quality of Life questionnaire were also collected.ResultsIn 170 patients with SNM, 39 had an IPG replacement. At a median of 29 month after replacement, 32 and 7 patients reported respectively a similar and reduced satisfaction (7.6 ± 1.62 vs. 5.5 ± 0.87), p < .001. Satisfied patients were younger (65 years vs. 76 years, p < .001). Cleveland Clinic Fecal Incontinence Scores were not significantly different, but the satisfied group had a significantly better Fecal Incontinence Quality of Life score (p = .047). Only 5 patients needed an electrode change at the time of the IPG replacement or later.ConclusionsPatient satisfaction and efficiency remain high after IPG replacement. Older age has a negative impact on the outcome. Electrode replacement is rarely required and does not need to be performed routinely when an IPG is exhausted.Conflict Of InterestPaul-Antoine Lehur has a consulting agreement with Medtronic SA. This had no impact with the results of the study. The other authors have no conflict of interests to declare.© 2018 International Neuromodulation Society.

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