Neuromodulation is proven effective for
chronic fecal incontinence in patients who have failed or are not candidates
for more conservative treatments. A Medtronic-sponsored, prospective, multicenter
trial conducted under an FDA-approved investigational protocol with 120
implanted patients demonstrated a significant improvement in fecal incontinence
symptoms and quality of life.
For the 106
implanted patients with complete follow-up diaries at 12 months
83% achieved a
50% or greater reduction in incontinent episodes per week
quality-of-life scores improved significantly from baseline, as measured by the
four scales of the Fecal Incontinence Quality of Life instrument.