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Status:

COMPLETED

Sacral Nerve Stimulation for Anal Incontinence and Bowel Control

Lead Sponsor:

MedtronicNeuro

Conditions:

Fecal Incontinence and Constipation

Eligibility:

All Genders

18-75 years

Phase:

PHASE4

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    November 1 1998

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    September 1 2012

    Estimated Enrollment :

    140 Patients enrolled

    Trial Details

    Trial ID

    NCT00200005

    Start Date

    November 1 1998

    End Date

    September 1 2012

    Last Update

    January 10 2014

    Active Locations (9)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (9 locations)

    1

    University of Minnesota

    Minneapolis, Minnesota, United States

    2

    Danube Hospital/SMZ-Ost

    Vienna, Austria

    3

    Aarhus University Hospital

    Aarhus, Denmark

    4

    Herlev Hospital

    Copenhagen, Denmark