Sacral Nerve Stimulation for Anal Incontinence and Bowel Control (MDT-301)

Medtronic

Status and phase

Completed

Phase 4

Conditions

Fecal Incontinence and Constipation

Treatments

Device: Type: Implantable neurostimulator; InterStim

Study type

Interventional

Funder types

Industry

Identifiers

NCT00200005

Amendment III (Jul 01, 2009)

Mdt-301 November 03,1998

Amendment II (Jan 31, 02)

Amendment I (Dec 14, 99),

Mdt-301 (Nov 03, 98),

Details and patient eligibility

About

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

Enrollment

140 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.