Clinical Study of Sacral Nerve Stimulation Therapy in Patients with Chronic Fecal Incontinence using MDT-3110
- Conditions
- Chronic Fecal Incontinence
- Registration Number
- JPRN-UMIN000004464
- Lead Sponsor
- Medtronic Japan Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method