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This research is being carried out in order to compare two alternative versions of the Neurotech Vital Devices which have been set up to provide two different types of stimulation. Both these devices will be fully functioning devices and the investigators want to collect information on your perception of the two alternative modes. The patient will be asked to provide feedback on both devices which will look identical. The patient will not be told in which order the units were given to them until the completion of your visit.
The Neurotech Vital Device is connected to a series of conductive hydrogel electrodes strategically positioned in and around the pelvic area of the user. The electrode positions and current pathways deliver therapeutic stimulation to the pelvic floor muscles resulting in repeated contraction of the intended muscle group. Pilot study data has shown this novel approach to produce extremely favorable adaptation and improvement in patient's symptoms following intervention. In order to capture the intended electrode position a stand-alone garment that will allow the end user to re-position electrodes on multiple re-applications is required. The Neurotech Vital Device garment is CE Marked as a Class IIa medical device and it is CE Marked, as part of the Neurotech Vital Device, in line with Medical Device Directive 93/42/EC as amended by 2007/47/EC. The Neurotech Vital Device garment is not cleared by the FDA through the 510 (k) pre-market notification process in the USA but would be considered a Class II device as part of the Neurotech Vital Device.
The purpose of this validation study is to establish the suitability of the Neurotech Vital device in which the treatment stimulation parameters have been markedly attenuated (defined as 'modified Neurotech Vital device') prior to its use as one of the treatments in a randomised, controlled, double-blind study to be conducted in patients with stress urinary incontinence in Germany (Study No: BMR-11-1002).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Neurotech Vital Device | Experimental | Checking to observe stimulation delivered using this device |
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| Neurotech Vital Device | Active Comparator | Checking to see if stimulation observed using this device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurotech Vital Device | Device | 5 minute treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this validation study is to verify that the Modified Neurotech Vital Device does not elicit a pelvic floor contraction compared to the Neurotech Vital Device. | The primary endpoint of the study is to demonstrate that no volunteers elicit a contraction of the pelvic floor muscle with the Modified Neurotech Vital Device and that all the volunteers elicit a contraction of the pelvic floor muscle with the Neurotech Vital Device. Contraction of the pelvic floor muscles will be assessed by using sonographic/real time ultrasound imaging/recording (mean of three measurements of pelvic floor displacement achieved during maximum threshold intensity electrical stimulation). | Day1 |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary objective of this validation study is to verify that the Modified Neurotech Vital Device is perceived by the volunteers as a valid treatment option in terms of sensation. | Subjects will also be asked to complete a feedback questionnaire on the use of the Modified Neurotech Vital Device to verify that it is perceived as a valid treatment option. | Day1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Georgia College and State University | Dahlonega | Georgia | 30597 | United States |
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| Modified Neurotech Vital Device | Device | 5 minute stimulation |
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