Multicenter European study to evaluate efficacy and safety of sacral nerve stimulation with InterStim Therapy to treat fecal incontinence or constipation

140 patients (7 study groups, up to 20 implanted patients per study group)

Fecal Incontinence groups:

Main Inclusion Criteria:

• Fecal incontinence (defined as incontinence to solid or liquid stool > 1 / week);
• Failed biofeedback or medical therapy;

Groups 1 - 5 patients with:

• Group 1) Circumferentially intact external anal sphincter, no previous surgery;
• Group 2) Circumferentially intact external anal sphincter after surgical repair;
• Group 3) Rectal prolapse repaired with a rectopexy;
• Group 4) Spinal injury including disc prolapse;
• Group 5) Sigmoid or partial rectal resection with colorectal or coloanal anastomosis

Constipation groups:

Main Inclusion Criteria:

• Chronic constipation (defined as </= 2 weekly bowel movements; and/or >25% of bowel movements required straining; and/or >25% of bowel movements patient did not feel empty afterwards) with symptoms more than 1 year
• Failed biofeedback or medical therapy;

Groups 6 - 7 patients with:

• Group 6) Idiopathic slow transit constipation as proven on colonic transit studies;
• Group 7) Normal colonic transit studies but chronic constipation due to either pelvic floor dysfunction or disordered defecation.