Outcome of Sacral Nerve Stimulation for Fecal Incontinence at 5 Years

Abstract

This study aimed to evaluate the outcome of sacral nerve stimulation (SNS) for fecal incontinence at 5 years after implantation and to identify predictors of sustained efficacy. There is a lack of knowledge about the long-term outcome of SNS for fecal incontinence. Prospectively collected data from patients who underwent implantation of an SNS device between 2001 and 2006 were reviewed. One hundred and one patients were available for outcome evaluation at 5 years. Sixty of 101 patients [42.6% on intention-to-treat (ITT) and 55.6% per protocol (PP)] reported a favorable outcome, 41 patients (ITT 29.1%; PP 38.0%) reported an unfavorable outcome, of whom 24 patients (ITT 17.0%; PP 22.2%) had their device explanted or permanently switched off before 5 years. Wexner incontinence scores improved significantly from a baseline median of 16 (range 6-20) to a median of 6 (range 0-20) at 3 months (P < 0.0001), and the improvement compared with baseline was maintained throughout the 5-year follow-ups (P < 0.0001).Age was a negative predictive factor [odds ratio (OR): 0.96 each year increase, 95% confidence interval (CI): 0.92-0.99; P = 0.016]. Positive predictors included improvement of urge incontinence episodes during percutaneous nerve evaluation (OR: 10.8; 95% CI: 1.72-132; P = 0.036), improvement of incontinence scores at 6 months from baseline (OR: 6.29; 95% CI: 1.33-34.3; P = 0.025), particularly improvement of incontinence scores from 3 to 6 months (OR: 41.5; 95% CI: 3.51-811; P = 0.007). Overall, 521 reportable events were recorded from 94 patients (93.1%). On an ITT analysis, 42.6% of patients reported favorable outcomes at 60 months. Patient's age, improvement of urge incontinence during PNE, and sustained efficacy during the first 6 months after implantation are some of the predictors identified.