To systematically review the literature regarding efficacy and adverse events of sacral nerve stimulation (SNS) via the InterStim device for treatment of women with refractory overactive bladder (OAB).

We searched MEDLINE, Embase, Web of Science, and the Cochrane Collaboration databases from 1980 to September 2008. All English studies reporting on efficacy or adverse events of SNS for the treatment of refractory OAB were considered. Only studies where 30 or more women received the complete therapy (implanted lead and generator) were included. The quality of the studies (good, fair, or poor) was assessed based on predefined criteria.

Seven studies were designated “good” regarding efficacy of SNS for OAB. Multiple authors reported results from the same cohort of patients. In this instance, the highest quality study was chosen, leaving three independent studies regarding efficacy. In these studies, incontinent episodes per day and pad usage significantly improved after SNS therapy. Six studies were designated “good” regarding adverse events. Using tined leads, surgical revision rates ranged from 3% to 16%. Six percent of patients were explanted due to lack of efficacy and 5–11% of patients were explanted due to infection.

Based on observational data, SNS appears effective for treatment of OAB in women. Adverse event rates with tined leads are lower than previously published estimates using non‐tined leads. High‐quality studies are needed to confirm our findings and to provide additional data regarding reprogramming, quality of life, and efficacy when compared to other therapies. Neurourol. Urodynam. 29:S18–S23, 2010. © 2010 Wiley‐Liss, Inc.