University of Michigan
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT04384172
The researchers want to see if nerve stimulation interventions cause a change in vaginal blood flow. This intervention was performed in women who have neurogenic (spinal cord injury) or non-neurogenic sexual dysfunction and healthy women.
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Notify Me18 year and older
Female
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
Two nerve stimulation locations (genital nerve and tibial nerve) were targeted with skin-surface electrical stimulation in separate experimental sessions.
This study was designed as a crossover study, but all participant data was analyzed together due to small enrollment size.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Non-dysfunction participants, no spinal cord injury
Inclusion criteria
Exclusion criteria
Sexual dysfunction participants, non- spinal cord injury
Inclusion criteria
Exclusion criteria
Sexual dysfunction participants with spinal cord injury
Inclusion criteria
Exclusion criteria
Standard Transcutaneous electrical nerve stimulation (TENS) device (Empi Select 199584, Medi-Stim Inc.)
Electrical stimulation applied to target the tibial nerve on one leg, with electrodes above the malleolus and on the bottom of the foot
Standard Transcutaneous electrical nerve stimulation (TENS) device (Empi Select 199584, Medi-Stim Inc.)
Electrical stimulation applied to target the genital nerve, with electrodes on either side of the clitoris.
Time frame: Test baseline (approximately minute 0) up to Test completion (approximately minute 60)
VPA will be measured by a vaginal plethysmography transducer. A sensor placed in the vagina will measure changes in blood flow.
Time frame: Test baseline (approximately minute 0) up to Test completion (approximately minute 60)
A heart rate monitor (e.g. electrocardiogram or pulse oximetry) will be placed on the participant's arm, hand, or chest (as is appropriate per monitor)
Time frame: Test baseline (approximately minute 0) up to Test completion (approximately minute 60)
A blood pressure monitor will be placed on the participant's arm, hand, or chest (as is appropriate per monitor) to monitor off-target autonomic responses.
Time frame: Test baseline (approximately minute 0) up to Test completion (approximately minute 60)
Subjective arousal will be evaluated by participants using a five point Likert scale, where 1 being no arousal and 5 being greatest arousal. Values are presented as the average change in arousal score after stimulation, from the baseline measures.
University of Michigan
Other
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