Sacral Nerve Stimulation for Anal Incontinence and Bowel Control - Full Text View

Purpose

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

Condition	Intervention	Phase
Fecal Incontinence and Constipation	Device: Type: Implantable neurostimulator; InterStim	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Sacral Nerve Stimulation for Anal Incontinence and Bowel Control

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement Constipation

U.S. FDA Resources

Further study details as provided by MedtronicNeuro:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]


Estimated Enrollment:	140
Study Start Date:	November 1998
Study Completion Date:	September 2012
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: InterStim therapy Patients being treated with sacral neuromodulation with InterStim therapy.	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. Other Names: InterStim Model 3023 InterStim Model 3058

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200005

Locations


United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States
Austria
Danube Hospital/SMZ-Ost
Vienna, Austria
Denmark
Aarhus University Hospital
Aarhus, Denmark
Herlev Hospital
Copenhagen, Denmark
Germany
University Hospital Erlangen
Erlangen, Germany
Netherlands
Maastricht University Hospital
Maastricht, Netherlands
Spain
Hospital Mutua de Terrassa
Terrassa, Spain
Sweden
Danderyd Hospital
Stockholm, Sweden
United Kingdom
St. Mark's Hospital
London, United Kingdom

Sponsors and Collaborators

MedtronicNeuro

Investigators


Principal Investigator:	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- Aarhus, Denmark

More Information

Publications:

Matzel KE, Kamm MA, Stösser 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.

Jarrett ME, Matzel KE, Stösser 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.

Jarrett ME, Matzel KE, Christiansen J, Baeten CG, Rosen H, Bittorf B, Stösser 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.

Jarrett ME, Matzel KE, Stösser 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. 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.

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.


Responsible Party:	MedtronicNeuro
ClinicalTrials.gov Identifier:	NCT00200005 History of Changes
Other Study ID Numbers:	Mdt-301 November 03,1998 Mdt-301 (Nov 03, 98), Amendment I (Dec 14, 99), Amendment II (Jan 31, 02) Amendment III (Jul 01, 2009)
Study First Received:	September 12, 2005
Last Updated:	January 9, 2014
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by MedtronicNeuro:


Slow transit constipation Fecal incontinence Constipation Idiopathic slow transit constipation Chronic constipation

Additional relevant MeSH terms:


Constipation Fecal Incontinence Signs and Symptoms, Digestive Signs and Symptoms	Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases

ClinicalTrials.gov processed this record on September 29, 2016

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