Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InterStim Sacral Nerve Stimulation Therapy | Device | Open label study. All subjects that qualify for the study will be implanted. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sudha Iyer, PhD | Medtronic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Medtronic for specific site information | Los Angeles | California | United States | |||
| Contact Medtronic for specific site information |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20160636 | Result | Wexner SD, Coller JA, Devroede G, Hull T, McCallum R, Chan M, Ayscue JM, Shobeiri AS, Margolin D, England M, Kaufman H, Snape WJ, Mutlu E, Chua H, Pettit P, Nagle D, Madoff RD, Lerew DR, Mellgren A. Sacral nerve stimulation for fecal incontinence: results of a 120-patient prospective multicenter study. Ann Surg. 2010 Mar;251(3):441-9. doi: 10.1097/SLA.0b013e3181cf8ed0. | |
| 20354809 |
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Implanted Subjects | Subjects implanted with Sacral Nerve Stimulation (SNS) device. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | 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. | 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. | 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. | Baseline and 12 months |
| San Francisco |
| California |
| United States |
| Contact Medtronic for specific site information | Washington D.C. | District of Columbia | United States |
| Contact Medtronic for specific site information | Weston | Florida | United States |
| Contact Medtronic for specific site information | Chicago | Illinois | United States |
| Contact Medtronic for specific site information | Kansas City | Kansas | United States |
| Contact Medtronic for specific site information | New Orleans | Louisiana | United States |
| Contact Medtronic for specific site information | Burlington | Massachusetts | United States |
| Contact Medtronic for specific site information | Minneapolis | Minnesota | United States |
| Contact Medtronic for specific site information | Cleveland | Ohio | United States |
| Contact Medtronic for specific site information | Oklahoma City | Oklahoma | United States |
| Contact Medtronic for specific site information | Fort Worth | Texas | United States |
| Contact Medtronic for specific site information | Fleurimont | Quebec | Canada |
| Wexner SD, Hull T, Edden Y, Coller JA, Devroede G, McCallum R, Chan M, Ayscue JM, Shobeiri AS, Margolin D, England M, Kaufman H, Snape WJ, Mutlu E, Chua H, Pettit P, Nagle D, Madoff RD, Lerew DR, Mellgren A. Infection rates in a large investigational trial of sacral nerve stimulation for fecal incontinence. J Gastrointest Surg. 2010 Jul;14(7):1081-9. doi: 10.1007/s11605-010-1177-z. Epub 2010 Mar 31. |
| 1 Month Follow-up |
|
| 3 Month Follow-up |
|
| 6 Month Follow-up |
|
| 12 Month Follow-up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Implanted Subjects | Subjects implanted with Sacral Nerve Stimulation (SNS) device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Weekly Fecal Incontinent Episodes | A bowel diary was used by subjects to record information about their bowel elimination frequency. Over the 14-day diary period, subjects recorded the date and time of each bowel episode and responded to questions related to each bowel episode, including amount of incontinence (none, staining, minor soiling, major soiling) and urgency (no, yes). A bowel movement was considered incontinent if the amount of incontinence was minor or major soiling. | Mean | Standard Deviation | incontinent episodes per week |
| |||||||||||||||||||||
| Weekly Fecal Incontinent Days | A bowel diary was used by subjects to record information about their bowel elimination frequency. Over the 14-day diary period, subjects recorded the date and time of each bowel episode and responded to questions related to each bowel episode, including amount of incontinence (none, staining, minor soiling, major soiling) and urgency (no, yes). A bowel movement was considered incontinent if the amount of incontinence was minor or major soiling. A day in a diary period was considered as an incontinent day if there was at least one incontinent episode during that day. | Mean | Standard Deviation | incontinent days per week |
| |||||||||||||||||||||
| Weekly Urgent Fecal Incontinent Episodes | A bowel diary was used by subjects to record information about their bowel elimination frequency. Over the 14-day diary period, subjects recorded the date and time of each bowel episode and responded to questions related to each episode, including amount of incontinence (none, staining, minor soiling, major soiling) and urgency (no, yes). A bowel movement was considered incontinent if the amount of incontinence was minor or major soiling. A bowel movement was considered urgent if the answer to the urgency question was yes and it was associated with incontinence. | Mean | Standard Deviation | urgent incontinent episodes per week |
| |||||||||||||||||||||
| Fecal Incontinence Quality of Life (FIQOL) Scale 1 - Lifestyle | Baseline measure from all subjects who were successfully implanted and completed the Fecal Incontinence Quality of Life (FIQOL) at baseline, n=119. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. | Mean | Standard Deviation | units on a scale |
| |||||||||||||||||||||
| FIQOL Scale 2 - Coping/Behavior | Baseline measure from all subjects who were successfully implanted and completed the FIQOL at baseline, n=119. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. | Mean | Standard Deviation | units on a scale |
| |||||||||||||||||||||
| FIQOL Scale 3 - Depression/Self-Perception | Baseline measure from all subjects who were successfully implanted and completed the FIQOL at baseline, n=119. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. | Mean | Standard Deviation | units on a scale |
| |||||||||||||||||||||
| FIQOL Scale 4 - Embarrassment | Baseline measure from all subjects who were successfully implanted and completed the FIQOL at baseline, n=119. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | proportion of subjects | Baseline and 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | 95% Confidence Interval | proportion of subjects | Baseline and 12 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | 95% Confidence Interval | proportion of subjects | Baseline and 12 months |
|
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Implanted Subjects | Subjects implanted with Sacral Nerve Stimulation (SNS) device. | 41 | 120 | 88 | 120 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site infection | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
| |
| Perianal abscess | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
| |
| Benign neoplasm of adrenal gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | Non-systematic Assessment |
| |
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | Non-systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Eating disorder | Psychiatric disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Cervical myelopathy | Nervous system disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Rectal prolapse | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Volvulus of bowel | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Vaginal pain | Reproductive system and breast disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Implant site pain | General disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Therapeutic product ineffective | General disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Implant site erosion | General disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Ulcer | General disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA (8.0) | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (8.0) | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (8.0) | Non-systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA (8.0) | Non-systematic Assessment |
| |
| Lead migration/dislodgment | General disorders | MedDRA (8.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site infection | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Faecal incontinence | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Implant site pain | General disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Laboratory test abnormal | Investigations | MedDRA (8.0) | Non-systematic Assessment |
| |
| Change in sensation of stimulation | General disorders | MedDRA (8.0) | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chad Giese | Medtronic Neuromodulation | 763-377-5955 | chad.giese@medtronic.com |
| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| Australia |
|
|
|
|
|
|
|
|
|
|
|
|
|