Effect of Peripheral Neuromodulation on Vaginal Blood Flow - Study 2

NACompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

September 14, 2022

Primary Completion Date

June 5, 2024

Study Completion Date

June 5, 2024

Conditions
Female Sexual DysfunctionFemale Sexual Dysfunction Due to Physical Condition
Interventions
DEVICE

Transcutaneous electrical nerve stimulation - Tibial Nerve

"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"

DEVICE

Transcutaneous electrical nerve stimulation - Genital Nerve

"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."

BEHAVIORAL

Neutral and Erotic Film Clip Alternation

During the testing period, participants will first view a 5-minute neutral film depicting nature scenes to allow blood flow levels to stabilize. This will be followed by a 10-minute period while the subject watches an erotic film clip for assessment of arousal responses without electrical stimulation. A 10-minute clip of the same neutral film will follow, to allow blood flow levels to return to baseline. Five minutes into this film, electrical stimulation will be resumed at the previously determined amplitude. Finally, the subject will view another 10-minute erotic film clip depicting similar sexually explicit material as the first while electrical stimulation remains on as the last sequence in the testing. Physiological arousal will be assessed with a vaginal photoplethysmography probe, yielding vaginal pulse amplitude (VPA) for analysis. Subjective arousal will be assessed with a subjective arousal questionnaire.

Trial Locations (1)

48109

University of Michigan, Ann Arbor

All Listed Sponsors
collaborator

International Society for the Study of Women's Sexual Health

UNKNOWN

collaborator

The Craig H. Neilsen Foundation

OTHER

lead

University of Michigan

OTHER