Effect of Peripheral Neuromodulation on Vaginal Blood Flow

October 28, 2025 updated by: Timothy Bruns, University of Michigan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Non-dysfunction participants, no spinal cord injury

Inclusion Criteria:

  • Adult (over 18 years old) cis-gender female
  • Neurologically stable
  • Sexually active at least once per month
  • Able to consent and communicate effectively with research team

Exclusion Criteria:

  • Male
  • Pregnancy or planning to become pregnant during study period
  • Sexual dysfunction, per short-form Female Sexual Function Index (FSFI) score below 19
  • Lubrication difficulties, per short-form FSFI lubrication subdomain score below or equal to 4
  • Clinically diagnosed bladder dysfunction, pelvic pain, or other pelvic organ symptoms
  • Suspected or diagnosed epilepsy
  • Active infection or active pressure sores in the perineal region
  • Implanted pacemaker, defibrillator, spinal cord stimulator, or other nerve stimulator
  • Currently has or tested positive in the last 14 days for COVID-19 or is symptomatic for COVID-19.

Sexual dysfunction participants, non- spinal cord injury

Inclusion Criteria:

  • Adult (over 18 years old) cis-gender female
  • Neurologically stable
  • Sexually active at least once per month
  • Sexual dysfunction, per short-form FSFI score below 19
  • Lubrication difficulties, per short-form FSFI lubrication subdomain score below or equal to 3
  • Able to understand consent and communicate effectively with research team

Exclusion Criteria:

  • Male
  • Pregnancy or planning to become pregnant during study period
  • Clinically diagnosed bladder dysfunction, pelvic pain, or other pelvic organ symptoms
  • Active infection or active pressure sores in the pelvic region
  • Implanted pacemaker or defibrillator
  • Currently has or tested positive in the last 14 days for COVID-19 or is symptomatic for COVID-19.

Sexual dysfunction participants with spinal cord injury

Inclusion Criteria:

  • Adult (over 18 years old) cis-gender women
  • Clinically diagnosed spinal cord injury (AIS A-B) at vertebral level within C6-T10 at least six months prior or clinically diagnosed spinal cord injury (AIS C) at vertebral level within C4-T10 at least six months prior
  • Nominally sexually active, but at minimum interest in sexual pleasure even if fully self-induced
  • Sexual dysfunction, per short-form FSFI score below 19
  • Able to understand consent and communicate effectively with research team

Exclusion Criteria:

  • Male
  • Spinal cord injury at or above C5 level (C1-C5) if AIS A or B, or spinal cord injury at or above C3 level (C1-C3) if AIS C
  • Spinal cord injury below T10 vertebral level or reflexes not preserved
  • Acute worsening in motor or sensory function in the last month
  • Suspected or diagnosed epilepsy
  • Pregnancy or planning to become pregnant during study period
  • Active infection or active pressure sores in the perineal region
  • Implanted pacemaker or defibrillator
  • Currently has or tested positive in the last 14 days for COVID-19 or is symptomatic for COVID-19.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tibial nerve stimulation then Genital nerve stimulation

Participants who began the study with the tibial nerve stimulation and then proceeded to genital nerve stimulation

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 - 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.
Experimental: Genital nerve stimulation then Tibial nerve stimulation

Participants who began the study with the genital nerve stimulation and then proceeded to tibial nerve stimulation

Electrical stimulation applied to target the genital nerve, with electrodes on either side of the clitoris.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Average Vaginal Pulse Amplitude (VPA) During Stimulation From the Average Baseline Value
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.
Test baseline (approximately minute 0) up to Test completion (approximately minute 60)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Heart Rate After Stimulation From Baseline
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)
Test baseline (approximately minute 0) up to Test completion (approximately minute 60)
Percent Change in Mean Arterial Blood Pressure During Stimulation From Baseline
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.
Test baseline (approximately minute 0) up to Test completion (approximately minute 60)
Change in Subjective Arousal After Stimulation
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.
Test baseline (approximately minute 0) up to Test completion (approximately minute 60)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

The Craig H. Neilsen Foundation
International Society for the Study of Women's Sexual Health

Investigators

  • Principal Investigator: Tim Bruns, Ph.D., University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2020

Primary Completion (Actual)

March 15, 2022

Study Completion (Actual)

March 15, 2022

Study Registration Dates

First Submitted

May 7, 2020

First Submitted That Met QC Criteria

May 7, 2020

First Posted (Actual)

May 12, 2020

Study Record Updates

Last Update Posted (Actual)

November 12, 2025

Last Update Submitted That Met QC Criteria

October 28, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00148746

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans to share IPD at this time.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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