Sacral Nerve Stimulation for Constipation: Suboptimal Outcome and Adverse Events

Abstract

Sacral nerve stimulation is an emerging treatment for patients with severe constipation. There has been no substantial report to date on suboptimal outcomes and complications. We report our experience of more than 6 years by focusing on incidents and the management of reportable events. A retrospective review was performed on patients who underwent sacral nerve stimulation for constipation between August 2002 and September 2008. Collected data included patients' demographic data, type and management of suboptimal outcomes and complications, and stimulation parameters at the time of reportable events. Thirty-eight patients (32 women; mean age, 45.6 y; SD, 11.8; range, 21-66) received a permanent stimulator after a successful test period. The mean treatment duration was 25.7 months (SD, 20.4; range, 0-70). Twenty-two patients (58%) experienced at least one reportable event attributable to the treatment. The total of 58 reportable events were noted, including lack or loss of efficacy, pain, and undesired change of sensation. Reprogramming successfully managed 28 reportable events (48%), 19 events (33%) required surgical interventions, and 3 adverse events led to discontinuation of the treatment. Nearly 60% of patients who received sacral nerve stimulation for constipation experienced at least one reportable event. Although the events were often resolved by reprogramming, more than one-third required surgical intervention or discontinuation of therapy. Patients undergoing sacral nerve stimulation for constipation need to be informed of these possibilities. A systematic assessment is needed to identify the cause and optimize the management of reportable events.