Effect of Peripheral Neuromodulation on Vaginal Blood Flow - Study 2

Summary

The overall purpose of this research is to improve sexual function in women with sexual dysfunction. The goal of this study is to see if either of two nerve stimulation interventions cause a short-term change in vaginal blood flow. The effect of this intervention will be compared between women who have neurogenic (spinal cord injury) or non-neurogenic dysfunction and healthy women, to reveal mechanisms underlying neural control over vaginal blood flow.

Conditions

• Female Sexual Dysfunction
• Female 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.

Sponsors & Collaborators

• International Society for the Study of Women's Sexual Health

  collaborator UNKNOWN

• The Craig H. Neilsen Foundation

  collaborator OTHER

• University of Michigan

  lead OTHER

Principal Investigators

• Tim Bruns, Ph.D · University of Michigan

• Priyanka Gupta, M.D. · University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-09-14

Primary Completion

2024-06-05

Completion

2024-06-05

FDA Device

Yes

Countries

• United States

Study Locations