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Effect of Peripheral Neuromodulation on Vaginal Blood Flow

NCT04384172 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-11-12

Study results available
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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.

Conditions

  • Female Sexual Dysfunction
  • Spinal Cord Injuries

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.

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

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-11
Primary Completion
2022-03-15
Completion
2022-03-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04384172 on ClinicalTrials.gov