Fecal Incontinence and Constipation
Conditions
Keywords
Slow transit constipation, Fecal incontinence, Constipation, Idiopathic slow transit constipation, Chronic constipation
Brief summary
Multicenter European study to evaluate efficacy and safety of sacral nerve stimulation with InterStim Therapy to treat fecal incontinence or constipation
Interventions
Treatment with InterStim Therapy: all patients meeting inclusion/exclusion criteria undergo test screening and those who have successful outcomes receive a permanent implant.
Sponsors
Study design
Eligibility
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Austria, Denmark, Germany, Netherlands, Spain, Sweden, United Kingdom, United States