Outcome of sacral nerve stimulation for fecal incontinence at 5 years.

ABSTRACT

OBJECTIVE: 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. BACKGROUND: There is a lack of knowledge about the long-term outcome of SNS for fecal incontinence. METHODS: Prospectively collected data from patients who underwent implantation of an SNS device between 2001 and 2006 were reviewed. RESULTS: 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%). CONCLUSIONS: 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.