A randomized controlled trial by Tjandra et al. demonstrated that the InterStim system at 12 months post implant (n=53) was more effective than supervised optimal medical therapy consisting of bulking agents, pelvic floor exercises, and dietary management. Fecal continence was greatly improved with chronic sacral neuromodulation after implantation and was sustained during the follow-up period.1
In the supervised optimal medical therapy (OMT) group, there are no significant improvements in FI symptoms, Wexner scores, FIQOL Index, and SF-12 scores.
Adverse events with SNM included pain at implant site, seroma, and excessive tingling in the vaginal region.
In the Tjandra study, patients with the InterStim system show sustained improvement post implant for FIQOL Index scores (n=53, p<0.0001).1 Sacral Neuromodulation delivered by the InterStim™ system significantly improves all domains of the FIQOL Index (see table below), while optimal medical therapy (n=60) shows no effect at twelve months.
Adverse events with the InterStim™ system in this study include implant site pain, especially in slimmer patients; seroma, resolved after percutaneous aspiration; and excessive tingling in the vaginal region.1
Tjandra JJ, Chan MKY, Yeh CH, Murray-Green C. Sacral nerve stimulation is more effective than optimal medical therapy for severe fecal incontinence: a randomized, controlled study. Dis Colon Rectum. 2008;51(5):494-502.