This user evaluation study is to verify that the Modified Neurotech Vital Device does not stimulate the pelvic floor muscles compared with the Neurotech Vital Device.
This user evaluation study is to verify that the Modified Neurotech Vital Device does not stimulate the pelvic floor muscles compared with the Neurotech Vital Device. Stimulation of the pelvic floor muscles will be assessed by using sonographic/real time ultrasound imaging/recording with displacement measurement using onscreen callipers on the sonogram unit to assess contractions.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
10
verify no contraction is stimulated in the Modified Neurotech Vital.
Checking there is a contraction of the pelvic floor muscle when the treatment is administered with the Neurotech Vital Device
Using a sonographic/real time ultrasound imaging machine detect if a contraction is stimulated by the 5 minute treatment with the modified Neurotech Device and 5 minute treatment with 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).
Time frame: 5 minutes treatment with each device to measure if contraction occurrs on the ultrasound
Healthy Volunteers feedback questionnaires
The secondary objective of this user evaluation study is to verify that the Modified Neurotech Vital Device is perceived by the volunteers as a valid treatment option. The Modified Neurotech Vital Device will be considered an acceptable treatment option in relation to stimulation sensation if 70% yes/not sure responses are obtained to the question 'given what you have been told about this treatment, do you believe it could be effective?'.
Time frame: after 5 minutes of treatment
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