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Due to the extension of the clinical study duration and to avoid further delaying the reporting of results.
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Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the InterStim Micro System for sacral neuromodulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overactive Bladder Cohort | Other | Subjects with overactive bladder will be treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms. |
|
| Fecal Incontinence Cohort | Other | Subjects with fecal incontinence will be treated with InterStim Micro Therapy and followed-up regarding their fecal incontinence symptoms. |
|
| Non-Obstructive Urinary Retention Cohort | Other | Subjects with non-obstructive urinary retention will be treated with InterStim Micro Therapy and followed-up regarding their non-obstructive urinary retention symptoms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InterStim Micro | Device | Eligible subjects will receive InterStim Micro therapy. Commercial devices will be used within their intended use as described in each geography's approved instructions for use |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline for HRQL Total Score | The Overactive Bladder Quality of Life Questionnaire (OAB-q) is a 33-item validated questionnaire that was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL).8 Specifically, The OAB-q consists of an 8-item symptom bother scale and 25-item HRQL scale with 4 domains: coping (8 items), concern/worry (7 items), sleep (5 items) and social interaction (5 items). The score for each of OAB-q domain are summed and transformed to a score ranging from zero to 100. We are reporting the change from baseline for HRQL total score. If the change is positive, it means a better quality of life. The higher the positive change is, the better the quality of life is. | 3 months |
| Change From Baseline in CCIS Score | The Cleveland Clinic Incontinence Score (Wexner Score) is an established 5-item questionnaire that was developed to assess the frequency and severity of fecal incontinence. CCIS-Wexner score ranges between 0 and 20. Higher scores indicate worse incontinence. We are reporting the change from baseline for CCIS Score. If the change is negative, the quality of life improved from baseline. The more negative the score is, the better the quality of life is. | 3 months |
| Change From Baseline in the Number of CISC/Day | Subjects reported the clean intermittent self-catheterizations on voiding diaries for 7 consecutive days. We are reporting the change from baseline. If the change is negative, the quality of life is improved from baseline. | 3 months |
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Overactive Bladder Cohort
Inclusion Criteria:
Exclusion Criteria:
Fecal Incontinence Cohort
Inclusion Criteria:
Exclusion Criteria:
Non-Obstructive Urinary Retention Cohort
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mylène Champs | Medtronic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Coast Institute for Research | Jacksonville | Florida | 32258 | United States | ||
| Florida Urology Partners |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40186665 | Derived | Elterman D, Murphy M, Krlin R, Levine R, Yaklic J, Michaels J, Bleier J, Paquette I, Farmer R, Xavier K, Papi B, Wu M, Siproudhis L. Post-Market Study Evaluating Performance of the Rechargeable InterStim Micro System in Fecal Incontinence Patients. Int Urogynecol J. 2025 Apr;36(4):913-921. doi: 10.1007/s00192-025-06127-9. Epub 2025 Apr 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Overactive Bladder Cohort | Subjects with overactive bladder were treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms. |
| FG001 | Fecal Incontinence Cohort |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 12, 2019 | Dec 7, 2023 |
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| Tampa |
| Florida |
| 33606 |
| United States |
| First Urology | Jeffersonville | Indiana | 47130 | United States |
| Saint Elizabeth Healthcare | Edgewood | Kentucky | 41017-3403 | United States |
| University of Louisville Hospital | Louisville | Kentucky | 40202 | United States |
| Louisiana State University Health Sciences Center New Orleans | New Orleans | Louisiana | 70112 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Minnesota Urology (Woodbury) | Woodbury | Minnesota | 55125 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Prisma Health | Greenville | South Carolina | 29605 | United States |
| Colon Surgeons of Charleston | Mt. Pleasant | South Carolina | 29464 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Urology Partners of North Texas | Arlington | Texas | 76017 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| University Urology Associates | Toronto | Ontario | M5G 1E2 | Canada |
| CHU de Nantes - Hôtel Dieu | Nantes | 44000 | France |
| Centre Hospitalier Universitaire De Rennes | Rennes | 35033 | France |
| Maastricht Universitair Medisch Centrum (MUMC) | Maastricht | Netherlands |
| Kantonsspital St.Gallen | Sankt Gallen | 9007 | Switzerland |
| Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital | London | SE1 7EH | United Kingdom |
| The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
Subjects with fecal incontinence were treated with InterStim Micro Therapy and followed-up regarding their fecal incontinence symptoms.
| FG002 | Non-Obstructive Urinary Retention Cohort | Subjects with non-obstructive urinary retention will be treated with InterStim Micro Therapy and followed-up regarding their non-obstructive urinary retention symptoms. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overactive Bladder Cohort | Subjects with overactive bladder will be treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms. |
| BG001 | Fecal Incontinence Cohort | Subjects with fecal incontinence will be treated with InterStim Micro Therapy and followed-up regarding their fecal incontinence symptoms. |
| BG002 | Non-Obstructive Urinary Retention Cohort | Subjects with non-obstructive urinary retention will be treated with InterStim Micro Therapy and followed-up regarding their non-obstructive urinary retention symptoms. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race/Ethnicity, Customized | Number analyzed is different than overall because Race was not collected for sites in EMEA. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||
| Overactive Bladder Quality of Life (OAB-q) Questionnaire Health Related Quality of Life (HRQL) | The Overactive Bladder Quality of Life Questionnaire (OAB-q) is a 33-item validated questionnaire that was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL). Specifically, The OAB-q consists of an 8-item symptom bother scale and 25-item HRQL scale with 4 domains: coping (8 items), concern/worry (7 items), sleep (5 items) and social interaction (5 items). The score for each of OAB-q domain are summed and transformed to a score ranging from zero to 100. A higher score means a better quality of life. | Number analyzed differs from overall because this score applies only to subjects enrolled in the OAB cohort and was not collected for subjects in the FI and the NOUR Cohorts. | Mean | Standard Deviation | Total Score |
| ||||||||
| Cleveland Clinic Incontinence Score (CCIS) | Number analyzed differs from overall because this score applies only to subjects enrolled in the FI cohort and was not collected for subjects in the OAB and the NOUR Cohorts. | Mean | Standard Deviation | Score |
| |||||||||
| Clean intermittent self-catheterizations (CISC) per day | Number analyzed differs from overall because this measure applies only to subjects enrolled in the NOUR cohort and was not collected for subjects in the OAB and the FI Cohorts. | Mean | Standard Deviation | Clean intermittent self-catheterizations |
|
| 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 | Change From Baseline for HRQL Total Score | The Overactive Bladder Quality of Life Questionnaire (OAB-q) is a 33-item validated questionnaire that was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL).8 Specifically, The OAB-q consists of an 8-item symptom bother scale and 25-item HRQL scale with 4 domains: coping (8 items), concern/worry (7 items), sleep (5 items) and social interaction (5 items). The score for each of OAB-q domain are summed and transformed to a score ranging from zero to 100. We are reporting the change from baseline for HRQL total score. If the change is positive, it means a better quality of life. The higher the positive change is, the better the quality of life is. | This score is applicable only for the OAB cohort. | Posted | Mean | Standard Deviation | Total score on a scale | 3 months |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Change From Baseline in CCIS Score | The Cleveland Clinic Incontinence Score (Wexner Score) is an established 5-item questionnaire that was developed to assess the frequency and severity of fecal incontinence. CCIS-Wexner score ranges between 0 and 20. Higher scores indicate worse incontinence. We are reporting the change from baseline for CCIS Score. If the change is negative, the quality of life improved from baseline. The more negative the score is, the better the quality of life is. | This score is only applicable for FI subjects. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
| |||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in the Number of CISC/Day | Subjects reported the clean intermittent self-catheterizations on voiding diaries for 7 consecutive days. We are reporting the change from baseline. If the change is negative, the quality of life is improved from baseline. | This measure applies only to subjects in the NOUR Cohort. | Posted | Mean | Standard Deviation | Number of CISC/Day | 3 months |
|
Adverse events were collected from consent. We are reporting here the adverse events that started between enrollment (=neurostimulator implant) and exit.
Any adverse event meeting the definition of: serious adverse events and/or adverse device effects were considered reportable for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overactive Bladder Cohort | Subjects with overactive bladder will be treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms. | 1 | 68 | 3 | 68 | 5 | 68 |
| EG001 | Fecal Incontinence Cohort | Subjects with fecal incontinence will be treated with InterStim Micro Therapy and followed-up regarding their fecal incontinence symptoms. | 0 | 53 | 8 | 53 | 8 | 53 |
| EG002 | Non-Obstructive Urinary Retention Cohort | Subjects with non-obstructive urinary retention will be treated with InterStim Micro Therapy and followed-up regarding their non-obstructive urinary retention symptoms. | 0 | 27 | 4 | 27 | 14 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Superinfection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pancreatic carcinoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute myelomonocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medical device site discomfort | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Implant site pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Medical device site pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Device stimulation issue | Product Issues | MedDRA 25.0 | Systematic Assessment |
|
Enrollment was closed earlier than planned.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mylène Champs | Medtronic | 612-433-0600 | mylene.champs@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 23, 2020 | Dec 8, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Black |
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| Hispanic |
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| SPANISH/HISPANIC/LATINA |
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| Asian |
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| Netherlands |
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| United States |
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| United Kingdom |
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| France |
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| Switzerland |
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