Outcomes of Sacral Neurostimulation Lead Reimplantation for Fecal Incontinence: A Cohort Study.

BACKGROUND

Adverse events and complications have been reported after sacral neurostimulation for fecal incontinence, which may result in surgical revision and device explantation. Lead reimplantation may be feasible; however, available data regarding outcomes are less robust.

OBJECTIVE

The aim of this study was to determine the outcomes of sacral neurostimulation lead reimplantation for fecal incontinence.

DESIGN

This was a retrospective review of prospectively collected data.

SETTINGS

The study was conducted at 2 clinical sites from a single institution.

PATIENTS

Patients with fecal incontinence who underwent sacral neurostimulation implantation or reimplantation between 2011 and 2014 were included in the study.

INTERVENTIONS

Sacral neurostimulation reimplantation was the included intervention.

MAIN OUTCOME MEASURES

Change in the Cleveland Clinic Florida Fecal Incontinence Score (0 best; 20 worst) in reimplantation as compared with index implantation controls was the main measure. Secondary outcomes included the frequency and type of adverse events and complications.

RESULTS

A total of 112 patients underwent either sacral neurostimulation implantation or reimplantation between 2011 and 2014. Ninety-seven patients underwent an index percutaneous nerve stimulation trial, 93 of whom also underwent a stimulator implantation. Fifteen patients underwent lead reimplantation, with 5 performed before stimulator implantation and 10 after stimulator implantation. The index implanted and reimplanted groups had similar demographics, comorbidities, and complication profiles including explantation rates. The most common reason for reimplantation was lead related (6/15), including 4 lead migrations, 1 lead fracture, and 1 lead erosion. Significant decreases in the incontinence score were achieved in each group (index implantation: p < 0.001; reimplantation: p = 0.006). When comparing the efficacy of sacral neurostimulation therapy in decreasing the fecal incontinence score from baseline in each group, patients with an index implantation were found to have a more significant improvement in their incontinence score as compared with the reimplantation group (p = 0.047).

LIMITATIONS

This was a retrospective study. A large number of patients with incomplete functional assessment data were excluded from analysis.

CONCLUSIONS

The improvements in fecal incontinence are significantly better after index implantation than after reimplantation.