NCT04384172

Effect of Peripheral Neuromodulation on Vaginal Blood Flow

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Female Sexual Dysfunction
• Spinal Cord Injuries

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-11-11
• Primary completion: 2022-03-15
• Completion: 2022-03-15
• First posted: 2020-05-12
• Last updated: 2025-11-12
• Results posted: 2025-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study