Incidence and predictors of complications with sacral neuromodulation

Abstract

Objectives: To determine the incidence and predictors of complications with sacral nerve stimulation (SNS).

Methods: A prospective, longitudinal analysis of all patients treated with SNS was performed to define the incidence of complications and identify the predictors of these adverse events (AEs). All patients underwent staged SNS placement with the InterStim device for treatment of refractory voiding dysfunction. The patients were followed up for evidence of AEs and device efficacy. The patient and device variables were examined statistically for evidence of predictive value.

Results: From September 2001 to March 2008, 221 patients with a mean age of 48.8 years underwent SNS lead placement for the treatment of intractable urinary urgency/frequency (n = 121), urge incontinence (n = 63), or urinary retention (n = 37). Of this group, 202 patients (91.4%) experienced a >50% improvement in symptoms and underwent implantable pulse generator placement. At a mean follow-up of 36.9 months, 67 patients (30.3%) had experienced AEs (pain in 6, elective removal in 10, lack of efficacy in 11, trauma in 18, infection in 7, hematoma in 3, and lead migration in 12) requiring 44 lead revisions and 47 implantable pulse generator revisions. The significant predictors of AEs included a history of trauma (P < .001), a change in body mass index class (P < .001), enrollment in a pain clinic (P = .008), the duration of follow-up (P = .002), and a history of AEs (P < .001).

Conclusions: The results of our study have shown that SNS is an effective treatment for patients with intractable voiding dysfunction. Complications are not uncommon but can be minimized with better patient selection.