Clinical trial NCT00200005: Sacral Nerve Stimulation for Anal Incontinence and Bowel Control
Official title: Sacral Nerve Stimulation for Anal Incontinence and Bowel Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fecal Incontinence and Constipation
Keywords: Slow transit constipation
Fecal incontinence
Constipation
Idiopathic slow transit constipation
Chronic constipation
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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: 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.

Primary outcomes:
measure: 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
timeFrame: Annually
Secondary outcomes:
measure: 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.
timeFrame: Annually
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Vienna
country: Austria
facility: Danube Hospital/SMZ-Ost
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Herlev Hospital
city: Erlangen
country: Germany
facility: University Hospital Erlangen
city: Maastricht
country: Netherlands
facility: Maastricht University Hospital
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa
city: Stockholm
country: Sweden
facility: Danderyd Hospital
city: London
country: United Kingdom
facility: St. Mark's Hospital
Study officials:
affiliation: University Hospital Erlangen- Erlangen, Germany
name: Klaus Matzel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Vincent's Hospital- Melbourne, Australia. Former: St. Mark's Hospital, London, U.K.
name: Michael A Kamm, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Hospital- The Netherlands
name: Cor Baeten, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Herlev Hospital- Copenhagen, Denmark
name: John Christiansen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Danderyd Hospital- Stockholm, Sweden
name: Anders Mellgren, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Danube Hospital/SMZ-Ost- Vienna, Austria
name: Harald Rosen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Mutua de Terrassa- Terrassa, Spain
name: Albert Navarro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota- Minneapolis, USA
name: Robert Madoff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Mark's Hospital- London, UK
name: Carolynne Vaizey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Danderyd Hospital- Stockholm, Sweden
name: Claes Johansson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital
name: Soren Laurberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/s0140-6736(95)91799-3.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.