Trial Outcomes & Findings for Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence (NCT NCT00200057)
NCT ID: NCT00200057
Last Updated: 2013-01-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
285 participants
Primary outcome timeframe
Baseline and 12 months
Results posted on
2013-01-24
Participant Flow
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.
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.
Participant milestones
| Measure |
Implanted Subjects
Subjects implanted with Sacral Nerve Stimulation (SNS) device.
|
|---|---|
|
Overall Study
STARTED
|
120
|
|
Overall Study
1 Month Follow-up
|
117
|
|
Overall Study
3 Month Follow-up
|
116
|
|
Overall Study
6 Month Follow-up
|
114
|
|
Overall Study
12 Month Follow-up
|
111
|
|
Overall Study
COMPLETED
|
111
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Implanted Subjects
Subjects implanted with Sacral Nerve Stimulation (SNS) device.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Exited due to terminal illness of PI
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Change in medical condition
|
1
|
|
Overall Study
Infection
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
Baseline characteristics by cohort
| Measure |
Implanted Subjects
n=120 Participants
Subjects implanted with Sacral Nerve Stimulation (SNS) device.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
71 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
49 Participants
n=99 Participants
|
|
Age Continuous
|
60.5 years
STANDARD_DEVIATION 12.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
87 participants
n=99 Participants
|
|
Region of Enrollment
Canada
|
19 participants
n=99 Participants
|
|
Region of Enrollment
Australia
|
14 participants
n=99 Participants
|
|
Weekly Fecal Incontinent Episodes
|
9.39 incontinent episodes per week
STANDARD_DEVIATION 7.27 • n=99 Participants
|
|
Weekly Fecal Incontinent Days
|
4.51 incontinent days per week
STANDARD_DEVIATION 1.61 • n=99 Participants
|
|
Weekly Urgent Fecal Incontinent Episodes
|
4.95 urgent incontinent episodes per week
STANDARD_DEVIATION 4.88 • n=99 Participants
|
|
Fecal Incontinence Quality of Life (FIQOL) Scale 1 - Lifestyle
|
2.31 units on a scale
STANDARD_DEVIATION 0.85 • n=99 Participants
|
|
FIQOL Scale 2 - Coping/Behavior
|
1.49 units on a scale
STANDARD_DEVIATION 0.53 • n=99 Participants
|
|
FIQOL Scale 3 - Depression/Self-Perception
|
2.53 units on a scale
STANDARD_DEVIATION 0.81 • n=99 Participants
|
|
FIQOL Scale 4 - Embarrassment
|
1.60 units on a scale
STANDARD_DEVIATION 0.63 • n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Implanted Subjects
n=120 Participants
Subjects implanted with Sacral Nerve Stimulation (SNS) device.
|
|---|---|
|
Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week
|
0.73 proportion of subjects
Interval 0.64 to 0.81
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Implanted Subjects
n=120 Participants
Subjects implanted with Sacral Nerve Stimulation (SNS) device.
|
|---|---|
|
Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week
|
0.73 proportion of subjects
Interval 0.64 to 0.81
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Implanted Subjects
n=120 Participants
Subjects implanted with Sacral Nerve Stimulation (SNS) device.
|
|---|---|
|
Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle
|
0.92 units on a scale
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: Baseline and 12 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
Implanted Subjects
n=120 Participants
Subjects implanted with Sacral Nerve Stimulation (SNS) device.
|
|---|---|
|
Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior
|
1.12 units on a scale
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Baseline and 12 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
Implanted Subjects
n=120 Participants
Subjects implanted with Sacral Nerve Stimulation (SNS) device.
|
|---|---|
|
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
|
SECONDARY outcome
Timeframe: Baseline and 12 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
Implanted Subjects
n=120 Participants
Subjects implanted with Sacral Nerve Stimulation (SNS) device.
|
|---|---|
|
Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment
|
1.06 units on a scale
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Implanted Subjects
n=120 Participants
Subjects implanted with Sacral Nerve Stimulation (SNS) device.
|
|---|---|
|
Proportion of Subjects With at Least 50% Reduction in Number of Urgent Incontinent Episodes Per Week
|
0.71 proportion of subjects
Interval 0.62 to 0.79
|
Adverse Events
Implanted Subjects
Serious events: 41 serious events
Other events: 88 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Implanted Subjects
n=120 participants at risk
Subjects implanted with Sacral Nerve Stimulation (SNS) device.
|
|---|---|
|
Infections and infestations
Implant site infection
|
4.2%
5/120 • Number of events 5 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Infections and infestations
Urinary tract infection
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Infections and infestations
Diverticulitis
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Infections and infestations
Perianal abscess
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Infections and infestations
Pneumonia
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of adrenal gland
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Psychiatric disorders
Depression
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Psychiatric disorders
Delirium
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Psychiatric disorders
Eating disorder
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.7%
2/120 • Number of events 3 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Nervous system disorders
Cervical myelopathy
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Nervous system disorders
Epilepsy
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Cardiac disorders
Myocardial infarction
|
0.83%
1/120 • Number of events 2 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Cardiac disorders
Angina pectoris
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Vascular disorders
Hypertension
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Vascular disorders
Deep vein thrombosis
|
1.7%
2/120 • Number of events 2 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Vascular disorders
Varicose vein
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Gastrointestinal disorders
Proctalgia
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Gastrointestinal disorders
Rectal prolapse
|
4.2%
5/120 • Number of events 7 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.7%
2/120 • Number of events 2 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.83%
1/120 • Number of events 3 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Gastrointestinal disorders
Duodenitis
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Gastrointestinal disorders
Volvulus of bowel
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.7%
2/120 • Number of events 2 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Renal and urinary disorders
Urinary retention
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Renal and urinary disorders
Haematuria
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
General disorders
Implant site pain
|
3.3%
4/120 • Number of events 4 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
General disorders
Therapeutic product ineffective
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
General disorders
Implant site erosion
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
General disorders
Ulcer
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
General disorders
Lead migration/dislodgment
|
0.83%
1/120 • Number of events 1 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
Other adverse events
| Measure |
Implanted Subjects
n=120 participants at risk
Subjects implanted with Sacral Nerve Stimulation (SNS) device.
|
|---|---|
|
Infections and infestations
Implant site infection
|
6.7%
8/120 • Number of events 8 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
8/120 • Number of events 10 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Psychiatric disorders
Insomnia
|
5.0%
6/120 • Number of events 6 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Nervous system disorders
Paraesthesia
|
10.8%
13/120 • Number of events 16 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Gastrointestinal disorders
Faecal incontinence
|
24.2%
29/120 • Number of events 35 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
16/120 • Number of events 20 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Gastrointestinal disorders
Proctalgia
|
5.0%
6/120 • Number of events 7 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Gastrointestinal disorders
Constipation
|
5.8%
7/120 • Number of events 7 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.8%
7/120 • Number of events 7 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.2%
11/120 • Number of events 12 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.2%
11/120 • Number of events 11 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Renal and urinary disorders
Urinary incontinence
|
11.7%
14/120 • Number of events 14 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
General disorders
Implant site pain
|
23.3%
28/120 • Number of events 33 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
General disorders
Pain
|
6.7%
8/120 • Number of events 8 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
Investigations
Laboratory test abnormal
|
6.7%
8/120 • Number of events 13 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
|
General disorders
Change in sensation of stimulation
|
5.8%
7/120 • Number of events 9 • One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place