Fecal Incontinence
Conditions
Keywords
Fecal Incontinence, InterStim
Brief summary
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.
Interventions
DEVICEInterStim Sacral Nerve Stimulation Therapy
Open label study. All subjects that qualify for the study will be implanted.
Sponsors
MedtronicNeuro
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week | Baseline and 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle | Baseline and 12 months | 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. |
| Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior | Baseline and 12 Months | 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. |
| Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week | Baseline and 12 months | 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. |
| Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment | Baseline and 12 Months | 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. |
| Proportion of Subjects With at Least 50% Reduction in Number of Urgent Incontinent Episodes Per Week | Baseline and 12 months | 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. |
| Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception | Baseline and 12 Months | 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. |
Countries
Canada, United States
Participant flow
Recruitment details
The clinical investigation began on January 14, 2002, and the first implant occurred on May 03, 2002. The study was closed to enrollments on June 15, 2006, and the last implant occurred on August 04, 2006.
Pre-assignment details
All patients who signed an informed consent were considered enrolled in the study. Of the 285 subjects who enrolled in the study, 132 subjects underwent acute test stimulation with 129 proceeding to the sub-chronic test stimulation phase. Of these, 120 subjects qualified for permanent implant. All 120 patients were successfully implanted.
Participants by arm
| Arm | Count |
|---|---|
| Implanted Subjects Subjects implanted with Sacral Nerve Stimulation (SNS) device. | 120 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Change in medical condition | 1 |
| Overall Study | Death | 1 |
| Overall Study | Exited due to terminal illness of PI | 2 |
| Overall Study | Infection | 1 |
| Overall Study | Lack of Efficacy | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Implanted Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 49 Participants |
| Age, Categorical Between 18 and 65 years | 71 Participants |
| Age Continuous | 60.5 years STANDARD_DEVIATION 12.5 |
| Fecal Incontinence Quality of Life (FIQOL) Scale 1 - Lifestyle | 2.31 units on a scale STANDARD_DEVIATION 0.85 |
| FIQOL Scale 2 - Coping/Behavior | 1.49 units on a scale STANDARD_DEVIATION 0.53 |
| FIQOL Scale 3 - Depression/Self-Perception | 2.53 units on a scale STANDARD_DEVIATION 0.81 |
| FIQOL Scale 4 - Embarrassment | 1.60 units on a scale STANDARD_DEVIATION 0.63 |
| Region of Enrollment Australia | 14 participants |
| Region of Enrollment Canada | 19 participants |
| Region of Enrollment United States | 87 participants |
| Sex: Female, Male Female | 110 Participants |
| Sex: Female, Male Male | 10 Participants |
| Weekly Fecal Incontinent Days | 4.51 incontinent days per week STANDARD_DEVIATION 1.61 |
| Weekly Fecal Incontinent Episodes | 9.39 incontinent episodes per week STANDARD_DEVIATION 7.27 |
| Weekly Urgent Fecal Incontinent Episodes | 4.95 urgent incontinent episodes per week STANDARD_DEVIATION 4.88 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 88 / 120 |
| serious Total, serious adverse events | 41 / 120 |
Outcome results
Primary
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
Population: All subjects who were successfully implanted were included in the analysis. A modified worst-case analysis was used for missing data, where all subjects who were missing 12-month data were classified as failures, unless there was a subsequent diary available, in which case the subsequent diary was substituted for the missing 12-month data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Implanted Subjects | Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week | 0.73 proportion of subjects |
Comparison: The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.p-value: <0.000195% CI: [0.64, 0.81]Exact Binomial
Secondary
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
Population: All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Implanted Subjects | Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle | 0.92 units on a scale | Standard Deviation 0.92 |
p-value: <0.0001Wilcoxon signed-rank test
Secondary
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
Population: All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Implanted Subjects | Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior | 1.12 units on a scale | Standard Deviation 0.99 |
p-value: <0.0001Wilcoxon signed-rank test
Secondary
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
Population: All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Implanted Subjects | Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception | 0.86 units on a scale | Standard Deviation 0.96 |
p-value: <0.0001Wilcoxon signed-rank test
Secondary
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
Population: All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Implanted Subjects | Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment | 1.06 units on a scale | Standard Deviation 1 |
p-value: <0.0001Wilcoxon signed-rank test
Secondary
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
Population: All subjects who were successfully implanted were included in the analysis. A modified worst-case analysis was used for missing data, where all subjects who were missing 12-month data were classified as failures unless there was a subsequent diary available, in which case the subsequent diary was substituted for the missing 12-month data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Implanted Subjects | Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week | 0.73 proportion of subjects |
Comparison: The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.p-value: <0.000195% CI: [0.64, 0.81]Exact Binomial
Secondary
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
Population: All subjects who were successfully implanted were included in this analysis. The modified worst-case analysis for missing data was used, so that all subjects with missing 12-month data were classified as failures, unless there was a subsequent diary available, in which case the subsequent diary was substituted for the missing 12-month data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Implanted Subjects | Proportion of Subjects With at Least 50% Reduction in Number of Urgent Incontinent Episodes Per Week | 0.71 proportion of subjects |
Comparison: The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.p-value: <0.000195% CI: [0.62, 0.79]Exact Binomial