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
Post-market clinical follow-up for continued assessment of safety and performance of the InterStim basic evaluation lead and foramen needle(s) used during a therapy evaluation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basic evaluation | Other | Subjects with overactive bladder will go through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InterStim Basic Evaluation lead and foramen needle | Device | Commercial devices within their intended use as described in approved Instructions for Use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Motor or Sensory Response(s) During Lead Placement - by Subject | To characterize the proportion of subjects who demonstrate motor or sensory response(s) during lead placement using the InterStim basic evaluation lead. A motor or sensory response was determined at the time of lead placement. Amplitude was titrated up from 0 until a response was reported and/or observed. A sensory response was defined as the lowest amplitude where the subject first perceived sensation of the stimulation. A motor response was defined as the lowest amplitude of electrical stimulation where a motor response (e.g. bellows response, anal wink and/or plantar flexion of the big toe) was observed. | During lead implant procedure (approximately 20 minutes) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| BASIC Clinical Research Study Team | Medtronic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinellas Urology | St. Petersburg | Florida | 33710 | United States | ||
| Florida Urology Partners |
Not provided
Not provided
Not provided
Not provided
Not provided
Subjects were considered to be 'enrolled' in the study at the time of the BE Lead procedure.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Basic Evaluation Subjects | Out of 134 overactive bladder consented subjects in the study, 110 underwent basic evaluation with the commercially approved foramen needle and basic evaluation kit, and 107 subjects completed the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 10, 2019 | Oct 4, 2021 |
Not provided
Not provided
To characterize proportion of subjects who demonstrate motor or sensory response(s) during lead placement using the InterStim Basic Evaluation Lead.
Not provided
Not provided
Not provided
Not provided
| Tampa |
| Florida |
| 33606 |
| United States |
| Minnesota Urology (Plymouth) | Plymouth | Minnesota | 55441 | United States |
| Urologic Research and Consulting | Englewood | New Jersey | 07631 | United States |
| FirstHealth Urogynecology | Hamlet | North Carolina | 28345 | United States |
| Wright State Physicians | Fairborn | Ohio | 45234-2640 | United States |
| Prisma Health | Greenville | South Carolina | 29605-4627 | United States |
| Southern Urogynecology | West Columbia | South Carolina | 29169-3456 | United States |
| Urology Partners of North Texas | Arlington | Texas | 76017 | United States |
| Urology of Virginia | Virginia Beach | Virginia | 23642-1815 | United States |
| University Urology Associates | Toronto | Ontario | M5T 2S8 | Canada |
| Radboud UMC | Nijmegen | 6525 GA | Netherlands |
| The Bristol Urological Institute | Bristol | BS10 5NB | United Kingdom |
| The Newcastle upon Tyne Hospitals | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Salford Royal NHS Foundation Trust | Salford | M68HD | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
Subjects with overactive bladder who went through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit (110) and who had baseline information collected, were included.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Baseline | Subjects with overactive bladder who went through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit |
| 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 |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Ethnicity was only collected for subjects in the US - was not collected for EU or Canada. | Count of Participants | Participants |
| |||||||||||||||||
| Race (NIH/OMB) | Race was only collected for subjects in the US - was not collected for EU or Canada. | Count of Participants | Participants |
|
| 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 | Motor or Sensory Response(s) During Lead Placement - by Subject | To characterize the proportion of subjects who demonstrate motor or sensory response(s) during lead placement using the InterStim basic evaluation lead. A motor or sensory response was determined at the time of lead placement. Amplitude was titrated up from 0 until a response was reported and/or observed. A sensory response was defined as the lowest amplitude where the subject first perceived sensation of the stimulation. A motor response was defined as the lowest amplitude of electrical stimulation where a motor response (e.g. bellows response, anal wink and/or plantar flexion of the big toe) was observed. | Subjects with overactive bladder who went through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit (110) were included. | Posted | Count of Participants | Participants | During lead implant procedure (approximately 20 minutes) |
|
|
|
From time of consent to one-week post lead placement
All serious, device related, procedure-related, and/or therapy-related adverse events were considered reportable for this study
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 | Basic Evaluation Subjects | For the mortality and serious adverse events, all consented subjects (134) were included. Since non-serious events can only be device, therapy or stimulation related, only subjects with overactive bladder who went through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit (110) were included. | 0 | 134 | 1 | 134 | 3 | 110 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rianna Rapson (Prin. Clinical Research Specialist) | Medtronic | 763-526-2170 | rianna.k.rapson@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 14, 2020 | Oct 4, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D053202 | Urinary Incontinence, Urge |
| 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 |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
Not provided
Not provided
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|