Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT00200057
Eligibility Criteria:
Inclusion Criteria:
* Signed and dated informed consent.
* 18 years of age or older.
* Patient is diagnosed with chronic fecal incontinence of a duration greater than 6 months (\>12 months post-vaginal childbirth) and defined as \> 2 incontinent episodes on average per week of more than staining recorded during the baseline diary period.
* Failed or are not candidates for more conservative treatments.
* Willing and competent to completely and accurately fill out bowel diaries and questionnaires throughout the study.
Exclusion Criteria:
* Congenital anorectal malformations.
* Active participation in another bowel disorder investigational study.
* Present rectal prolapse.
* Previous rectal surgery (such as rectopexy or resection) or sphincteroplasty done \< 12 months prior to study enrollment (24 months for cancer).
* Neurological diseases such as clinically significant peripheral neuropathy or complete spinal cord injury (i.e. paraplegia).
* Grade III hemorrhoids.
* Known or suspected organic disorders of the bowel (i.e. Inflammatory bowel disease such as Crohn's or ulcerative colitis).
* 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.)
* Pregnancy or planned pregnancy.
* Patients for whom patient materials are not available in a language understood by the patient.
* Life expectancy of less than one year.
* 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).
* Patients with a history of pelvic irradiation who present with visible or functional effects of irradiation.
* Patients with active anal abscesses or fistulas.
* Patients with anatomical limitations that would prevent the successful placement of an electrode.
* Patients with knowledge of planned MRIs, diathermy, microwave, or RF energy.
* Patients with other implantable neurostimulators, pacemakers or defibrillators.
* Defect of external anal sphincter of \>60 degrees or amenable to surgical repair.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00200057
Study Brief:
Protocol Section:
NCT00200057