JPRN-UMIN000004464Completed未知
Clinical Study of Sacral Nerve Stimulation Therapy in Patients with Chronic Fecal Incontinence using MDT-3110 - Clinical Study of Sacral Nerve Stimulation Therapy in Patients with Chronic Fecal Incontinence using MDT-3110
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Medtronic Japan Co., Ltd.
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18years-old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
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.
Investigators
Similar Trials
Active, not recruiting
Not Applicable
The Efficacy of permanent sacral nerve Stimulation upon constipation symptoms in patients with severe constipation: A Randomised Controlled trialSlow transit constipationACTRN12611001192976Prof Ian COOK MD (SYD) FRACP59
Completed
Not Applicable
Surface Nerve Stimulation Treatment for OAB in ChildrenUrinary IncontinenceOveractive BladderNCT00282490University of Aarhus30
Recruiting
Not Applicable
Sacral nerve stimulation in treatment of fecal incontinence due to rectal hyposensitivityFecal incontinenceRectal hyposensitivitySurgery - Surgical techniquesOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonACTRN12613000099729Health Insurance Institute22
Completed
Not Applicable
Cost-Effectiveness of Sacral Nerve Stimulation by MDT-3110Chronic fecal incontinenceJPRN-UMIN000006500Medtronic Japan Co., Ltd.30
Recruiting
Unknown
Compared conventional and new stimulation methods for intractable neuropathic paieuropathic painJPRN-jRCT1042220094Saito Ryuta92