Sacral Nerve Stimulation for Anal Incontinence and Bowel Control

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2006

Interventions

  • Device: Type: Implantable neurostimulator; InterStim
    • Treatment with InterStim Therapy: all patients meeting inclusion/exclusion criteria undergo test screening and those who have successful outcomes receive a permanent implant.

Arms, Groups and Cohorts

  • Experimental: InterStim therapy
    • Patients being treated with sacral neuromodulation with InterStim therapy.

Clinical Trial Outcome Measures

Primary Measures

  • FI – number of FI episodes per week and/or number of days with FI per week. Constipation – number of bowel movements per week; &/or decrease defecations requiring straining; &/or decrease defecations where there was incomplete emptying
    • Time Frame: Annually

Secondary Measures

  • FI-number of days with staining/week;urgency with continent bowel movements; Improvement in QOL;* Improvement in anal canal pressure. Constipation – Improvement in Wexner constipation score; QOL.
    • Time Frame: Annually

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • MedtronicNeuro
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Klaus Matzel, MD, Principal Investigator, University Hospital Erlangen- Erlangen, Germany
    • Michael A Kamm, MD, Principal Investigator, St. Vincent’s Hospital- Melbourne, Australia. Former: St. Mark’s Hospital, London, U.K.
    • Cor Baeten, MD, Principal Investigator, Maastricht University Hospital- The Netherlands
    • John Christiansen, MD, Principal Investigator, Herlev Hospital- Copenhagen, Denmark
    • Anders Mellgren, MD, Principal Investigator, Danderyd Hospital- Stockholm, Sweden
    • Harald Rosen, MD, Principal Investigator, Danube Hospital/SMZ-Ost- Vienna, Austria
    • Albert Navarro, MD, Principal Investigator, Hospital Mutua de Terrassa- Terrassa, Spain
    • Robert Madoff, MD, Principal Investigator, University of Minnesota- Minneapolis, USA
    • Carolynne Vaizey, MD, Principal Investigator, St. Mark’s Hospital- London, UK
    • Claes Johansson, MD, Principal Investigator, Danderyd Hospital- Stockholm, Sweden
    • Soren Laurberg, MD, Principal Investigator, Aarhus University Hospital, Aarhus, Denmark

References

Matzel KE, Stadelmaier U, Hohenfellner M, Gall FP. Electrical stimulation of sacral spinal nerves for treatment of faecal incontinence. Lancet. 1995 Oct 28;346(8983):1124-7. doi: 10.1016/s0140-6736(95)91799-3.

Citations Reporting on Results

Matzel KE, Kamm MA, Stosser M, Baeten CG, Christiansen J, Madoff R, Mellgren A, Nicholls RJ, Rius J, Rosen H. Sacral spinal nerve stimulation for faecal incontinence: multicentre study. Lancet. 2004 Apr 17;363(9417):1270-6. doi: 10.1016/S0140-6736(04)15999-0.

Jarrett ME, Matzel KE, Stosser M, Baeten CG, Kamm MA. Sacral nerve stimulation for fecal incontinence following surgery for rectal prolapse repair: a multicenter study. Dis Colon Rectum. 2005 Jun;48(6):1243-8. doi: 10.1007/s10350-004-0919-y.

Jarrett ME, Matzel KE, Christiansen J, Baeten CG, Rosen H, Bittorf B, Stosser M, Madoff R, Kamm MA. Sacral nerve stimulation for faecal incontinence in patients with previous partial spinal injury including disc prolapse. Br J Surg. 2005 Jun;92(6):734-9. doi: 10.1002/bjs.4859.

Jarrett ME, Matzel KE, Stosser M, Christiansen J, Rosen H, Kamm MA. Sacral nerve stimulation for faecal incontinence following a rectosigmoid resection for colorectal cancer. Int J Colorectal Dis. 2005 Sep;20(5):446-51. doi: 10.1007/s00384-004-0729-7. Epub 2005 Apr 21.

Kamm MA, Dudding TC, Melenhorst J, Jarrett M, Wang Z, Buntzen S, Johansson C, Laurberg S, Rosen H, Vaizey CJ, Matzel K, Baeten C. Sacral nerve stimulation for intractable constipation. Gut. 2010 Mar;59(3):333-40. doi: 10.1136/gut.2009.187989.

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