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

Abstract

Long-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. Patients 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. In 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. Patient 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. Paul-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.