NCT00200005

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 1998

Longer than P75 for phase_4

Geographic Reach
8 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1998

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

January 10, 2014

Status Verified

January 1, 2014

Enrollment Period

8.1 years

First QC Date

September 12, 2005

Last Update Submit

January 9, 2014

Conditions

Fecal Incontinence and Constipation

Keywords

Slow transit constipationFecal incontinenceConstipationIdiopathic slow transit constipationChronic constipation

Outcome Measures

Primary Outcomes (1)

  • 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

    Annually

Secondary Outcomes (1)

  • 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.

    Annually

Study Arms (1)

InterStim therapy

EXPERIMENTAL

Patients being treated with sacral neuromodulation with InterStim therapy.

Device: Type: Implantable neurostimulator; InterStim

Interventions

Type: Implantable neurostimulator; InterStimDEVICE

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

Also known as: InterStim Model 3023, InterStim Model 3058
InterStim therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of Minnesota

Minneapolis, Minnesota, United States

Location

Danube Hospital/SMZ-Ost

Vienna, Austria

Location

Aarhus University Hospital

Aarhus, Denmark

Location

Herlev Hospital

Copenhagen, Denmark

Location

University Hospital Erlangen

Erlangen, Germany

Location

Maastricht University Hospital

Maastricht, Netherlands

Location

Hospital Mutua de Terrassa

Terrassa, Spain

Location

Danderyd Hospital

Stockholm, Sweden

Location

St. Mark's Hospital

London, United Kingdom

Location

Related Publications (6)

  • 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.

    PMID: 7475602BACKGROUND

  • 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.

    PMID: 15094271RESULT

  • 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.

    PMID: 15793647RESULT

  • 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.

    PMID: 15838899RESULT

  • 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.

    PMID: 15843939RESULT

  • 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.

    PMID: 20207638RESULT

MeSH Terms

Conditions

Fecal IncontinenceConstipation

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Klaus Matzel, MD

    University Hospital Erlangen- Erlangen, Germany

    PRINCIPAL INVESTIGATOR

  • Michael A Kamm, MD

    St. Vincent's Hospital- Melbourne, Australia. Former: St. Mark's Hospital, London, U.K.

    PRINCIPAL INVESTIGATOR

  • Cor Baeten, MD

    Maastricht University Hospital- The Netherlands

    PRINCIPAL INVESTIGATOR

  • John Christiansen, MD

    Herlev Hospital- Copenhagen, Denmark

    PRINCIPAL INVESTIGATOR

  • Anders Mellgren, MD

    Danderyd Hospital- Stockholm, Sweden

    PRINCIPAL INVESTIGATOR

  • Harald Rosen, MD

    Danube Hospital/SMZ-Ost- Vienna, Austria

    PRINCIPAL INVESTIGATOR

  • Albert Navarro, MD

    Hospital Mutua de Terrassa- Terrassa, Spain

    PRINCIPAL INVESTIGATOR

  • Robert Madoff, MD

    University of Minnesota- Minneapolis, USA

    PRINCIPAL INVESTIGATOR

  • Carolynne Vaizey, MD

    St. Mark's Hospital- London, UK

    PRINCIPAL INVESTIGATOR

  • Claes Johansson, MD

    Danderyd Hospital- Stockholm, Sweden

    PRINCIPAL INVESTIGATOR

  • Soren Laurberg, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

November 1, 1998

Primary Completion

December 1, 2006

Study Completion

September 1, 2012

Last Updated

January 10, 2014

Record last verified: 2014-01

Locations

ES(1)NL(1)AU(1)SE(1)DE(1)GB(1)US(1)DK(2)