Chronic Fecal Incontinence
Conditions
Interventions
Long term Sacral Nerve Stimulation by implanted MDT-3110
Sponsors
Medtronic Japan Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients from whom written consent can be obtained. 2. Patients who are 18 years of age or older. 3. Patients who are diagnosed with chronic fecal incontinence of a duration greater than 6 months (>12 months post-vaginal childbirth). Chronic fecal incontinence is defined as >2 incontinent episodes on average per week of more than staining (a stain on undergarments or the like) recorded in the bowel diary. 4. Patients who are failed or are not candidates for more conservative treatments. 5. Patients who are willing and competent to completely and accurately fill out bowel diaries and questionnaires throughout the study.
Exclusion criteria
Exclusion criteria: 1. Patients with congenital anorectal malformations. 2. Patients with a present rectal prolapse. 3. Patients with a defect of external anal sphincter of >60 degrees or amenable to surgical repair. 4. Patients with a previous rectal surgery (such as rectopexy or resection) or sphincteroplasty done less than 12 months prior to study enrollment (24 months for cancer). 5. Patients with neurological diseases such as clinically significant peripheral neuropathy or complete spinal cord injury (i.e., paraplegia). 6. Patients with a grade III hemorrhoid. 7. Patients with active anal abscesses or fistulas. 8. Patients with known or suspected organic disorders of the bowel (i.e. Inflammatory bowel disease such as Crohn's or ulcerative colitis). 9. Patients with chronic watery diarrhea, unmanageable by drugs or diet, as primary cause of fecal incontinence. (Incontinent episodes with a Bristol stool consistency of >=6 for >=4 days during the baseline diary period will be exclusionary, unless the investigator determines that the diary is not indicative of chronic watery diarrhea). 10. Patients who are pregnant or planned pregnancy. Patients with childbearing potential have to have a confirmed negative pregnancy test. 11. Patients with active participation in another bowel disorder investigational study. 12. Patients with a life expectancy of less than one year. 13. Patient characteristics indicating a poor understanding of the study or poor compliance with the study protocol (i.e., patients unable to adequately operate equipment, patients unwilling or unable to return for scheduled follow-up visits). 14. Patients with a history of pelvic irradiation who present with visible or functional effects of irradiation. 15. Patients with anatomical limitations that would prevent the successful placement of an electrode. 16. Patients with knowledge of planned MRIs, diathermy, microwave, or RF energy. 17. Patients with other implantable neurostimulators, pacemakers or defibrillators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: To estimate the proportion of patients (achievement rate) with at least 50% reduction from baseline in the number of incontinent episodes per week at 6 months after neurostimulator implant and, based on the distribution, to confirm the status of reaching the target achievement rate (>=50%). Safety: Adverse events observed during the study will be characterized. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To estimate the proportion of patients (achievement rate) with at least 50% reduction from baseline in the number of incontinent episodes per week at 12 months after neurostimulator implant and, based on the distribution, to confirm the status of reaching the target achievement rate (>=50%). 2. To estimate the proportion of patients (achievement rate) with at least 50% reduction from baseline in the number of incontinent days per week at 6 and 12 months after neurostimulator implant and, based on the distribution, to confirm the status of reaching the target achievement rate (>=50%). 3. To investigate improvements (as compared to baseline) in the Fecal Incontinence Quality of Life at 6 and 12 months after neurostimulator implant based on the changes and the 95% confidence intervals. 4. To estimate the proportion of patients (achievement rate) with at least 50% reduction from baseline in the number of urgent incontinent bowel movements per week at 6 and 12 months after neurostimulator implant and, based on the distribution, to confirm the status of reaching the target achievement rate (>=50%). | — |
Countries
Japan
Contacts
Public ContactFujimaro Takahashi
Medtronic Japan Co., Ltd. Neuromodulation
Outcome results
None listed