Sacral Nerve Stimulation for Anal Incontinence and Bowel Control

Fecal Incontinence and Constipation Clinical Trial

— MDT-301  

Official title:

Sacral Nerve Stimulation for Anal Incontinence and Bowel Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00200005
• Other study ID #: Mdt-301 November 03,1998
• Secondary ID: Mdt-301 (Nov 03,
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: January 9, 2014
• Start date: November 1998
• Est. completion date: September 2012

Study information

• Verified date: January 2014
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 2012
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Fecal Incontinence
• Fecal Incontinence and Constipation

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Countries where clinical trial is conducted

United States,  Austria,  Denmark,  Germany,  Netherlands,  Spain,  Sweden,  United Kingdom, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No