EFFICACY AT 12 MONTHS POST IMPLANT

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

INTERSTIM THERAPY RESULTS

Medtronic bowel control percent noting 47% of patients achieve complete continence with SNM.
Medtronic bowel control percent noting 66% of patients achieve high improvement in continence with SNM.

OPTIMAL MEDICAL TREATMENT RESULTS

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

Adverse events with SNM included pain at implant site, seroma, and excessive tingling in the vaginal region.

FIQOL INDEX — RANDOMIZED CONTROLLED STUDY: SNM VS. OPTIMAL MEDICAL THERAPY

In the Tjandra study, patients with the InterStim system show sustained improvement post implant for FIQOL Index scores (n=53, p<0.0001).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

FIQOL Score

Medtronic chart showing a change in FIQOL scare from baseline for Intersim therapy patients.

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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.