Fecal incontinence (FI) is a difficulty in storing gas, liquid stool or solid stool (bowel movement) in order to expel it at a proper time and place. Patients who suffer from FI may experience passive FI (difficulty in sensing stool in the rectum) or urgency (able to sense a bowel movement but cannot hold the stool until an acceptable time and place). FI is not a life-threatening disease, but it is often profoundly distressing and socially incapacitating. If a patient is suffering with symptoms of chronic FI despite trying oral medications, biofeedback and/or other more conservative treatments, a patient may be eligible to participate in a clinical research study to evaluate the safety and effectiveness of sacral nerve stimulation for the treatment of chronic fecal incontinence. One hundred-twenty (120) patients will be implanted with medical devices and followed closely for twelve months, and then once a year after that until the study closes. There are up to 20 centers in the United States.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
285
Open label study. All subjects that qualify for the study will be implanted.
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Los Angeles, California, United States
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San Francisco, California, United States
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Washington D.C., District of Columbia, United States
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Weston, Florida, United States
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Chicago, Illinois, United States
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Kansas City, Kansas, United States
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New Orleans, Louisiana, United States
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Burlington, Massachusetts, United States
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Minneapolis, Minnesota, United States
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Cleveland, Ohio, United States
...and 3 more locations
Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week
The primary efficacy objective was to demonstrate that at least 50% of subjects will achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline are considered "successes." The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of incontinent episodes per week from baseline to twelve months.
Time frame: Baseline and 12 months
Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week
This secondary objective was to demonstrate that at least 50% of subjects achieved at least 50% reduction in the number of incontinent days per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of fecal incontinent days per week at 12 months post-implant compared to baseline are considered "successes." The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of incontinent days per week from baseline to twelve months.
Time frame: Baseline and 12 months
Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle
This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.
Time frame: Baseline and 12 months
Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior
This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.
Time frame: Baseline and 12 Months
Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception
This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.
Time frame: Baseline and 12 Months
Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment
This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.
Time frame: Baseline and 12 Months
Proportion of Subjects With at Least 50% Reduction in Number of Urgent Incontinent Episodes Per Week
This secondary objective was to demonstrate that at least 50% of subjects achieved at least 50% reduction in the number of urgent incontinent episodes per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of urgent fecal incontinent episodes per week at 12 months post-implant compared to baseline are considered "successes." The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of urgent incontinent episodes per week from baseline to 12 months.
Time frame: Baseline and 12 months
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