Female Sexual DysfunctionNCT04384172

Effect of Peripheral Neuromodulation on Vaginal Blood Flow

A study testing Transcutaneous electrical nerve stimulation - Tibial Nerve and Transcutaneous electrical nerve stimulation - Genital Nerve in people with Female Sexual Dysfunction and Spinal Cord Injuries, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Female Sexual Dysfunction, Spinal Cord Injuries
What is being tested?: Transcutaneous electrical nerve stimulation - Tibial Nerve and Transcutaneous electrical nerve stimulation - Genital Nerve
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: 11 Nov 2020to 15 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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
Adult (over 18 years old) cis-gender female
Neurologically stable

Show all 15Show fewer

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
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

Who cannot join

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

Show all 26Show fewer

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
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
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Read the 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
Being tested: Transcutaneous electrical nerve stimulation - Tibial Nerve, Transcutaneous electrical nerve stimulation - Genital Nerve
Keywords: peripheral neuromodulation, stimulation, vaginal blood flow
Medical subject headings: Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcutaneous electrical nerve stimulation - Tibial NerveDevice
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
Transcutaneous electrical nerve stimulation - Genital NerveDevice
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.

Study groups in NCT04384172
Study group	Role	What they receive
Tibial nerve stimulation then Genital nerve stimulation	Experimental	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 Receives: Device: Transcutaneous electrical nerve stimulation - Tibial Nerve; Device: Transcutaneous electrical nerve stimulation - Genital Nerve
Genital nerve stimulation then Tibial nerve stimulation	Experimental	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. Receives: Device: Transcutaneous electrical nerve stimulation - Tibial Nerve; Device: Transcutaneous electrical nerve stimulation - Genital Nerve

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change in Average Vaginal Pulse Amplitude (VPA) During Stimulation From the Average Baseline Value
VPA will be measured by a vaginal plethysmography transducer. A sensor placed in the vagina will measure changes in blood flow.
Measured: Test baseline (approximately minute 0) up to Test completion (approximately minute 60)

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Nov 202015 Mar 2022

First posted12 May 2020
Study start11 Nov 2020
Primary completion15 Mar 2022
Study completion15 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Female Sexual DysfunctionStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: Participants were randomized to one arm and completed the other arm 1-5 months later.
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04384172
Sponsor's protocol ID: HUM00148746
Status last verified: Oct 2025
First submitted: 7 May 2020
Last updated: 12 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: There are no plans to share IPD at this time.

Publications

Zimmerman LL, Gupta P, O'Gara F, Langhals NB, Berger MB, Bruns TM. Transcutaneous Electrical Nerve Stimulation to Improve Female Sexual Dysfunction Symptoms: A Pilot Study. Neuromodulation. 2018 Oct;21(7):707-713. doi: 10.1111/ner.12846. Epub 2018 Sep 3.
PubMed 30247794

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Female Sexual Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Peripheral Neuromodulation on Vaginal Blood Flow
ClinicalTrials.gov ID: NCT04384172
Acronym / sponsor ID: HUM00148746
Conditions: Female Sexual Dysfunction, Spinal Cord Injuries
Keywords: peripheral neuromodulation, stimulation, vaginal blood flow
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: International Society for the Study of Women's Sexual Health, The Craig H. Neilsen Foundation
Study start: 11 Nov 2020 (actual)
Primary completion: 15 Mar 2022 (actual)
Study completion: 15 Mar 2022 (actual)
First posted: 12 May 2020 (actual)
Results: Posted 12 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: Participants were randomized to one arm and completed the other arm 1-5 months later.

Arm	Type	Receives
Tibial nerve stimulation then Genital nerve stimulation	Experimental	Device: Transcutaneous electrical nerve stimulation - Tibial Nerve, Device: Transcutaneous electrical nerve stimulation - Genital NerveParticipants 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
Genital nerve stimulation then Tibial nerve stimulation	Experimental	Device: Transcutaneous electrical nerve stimulation - Tibial Nerve, Device: Transcutaneous electrical nerve stimulation - Genital NerveParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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
Adult (over 18 years old) cis-gender female

Key exclusion criteria (26 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcutaneous electrical nerve stimulation - Tibial NerveStandard 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	Genital nerve stimulation then Tibial nerve stimulation, Tibial nerve stimulation then Genital nerve stimulation
Transcutaneous electrical nerve stimulation - Genital NerveStandard 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.	Device	Genital nerve stimulation then Tibial nerve stimulation, Tibial nerve stimulation then Genital nerve stimulation

Primary outcome

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.

3 secondary outcomes

Percent Change in Heart Rate After Stimulation From Baseline
Time frame: 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)
Change in Subjective Arousal After Stimulation
Time frame: Test baseline (approximately minute 0) up to Test completion (approximately minute 60)

Results and safety

Results posted to the registry on 12 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tibial nerve stimulation then Genital nerve stimulation	5	4
Genital nerve stimulation then Tibial nerve stimulation	4	1

Primary outcome: 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). Mean (Standard Deviation). Unit: Percent change

Measure	Tibial Nerve Stimulation n = 5	Genital Nerve Stimulation n = 7
Value	3.3 (14.2)	3.5 (26.7)

Population analysed: Data was analyzed for each treatment, regardless of the order in which the participant received it. One participant did not yield VPA data for either session.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 10 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tibial Nerve Stimulation	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Genital Nerve Stimulation	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30247794Zimmerman LL, Gupta P, O'Gara F, Langhals NB, Berger MB, Bruns TM. Transcutaneous Electrical Nerve Stimulation to Improve Female Sexual Dysfunction Symptoms: A Pilot Study. Neuromodulation. 2018 Oct;21(7):707-713. doi: 10.1111/ner.12846. Epub 2018 Sep 3.
Individual participant dataSharing planned: No. There are no plans to share IPD at this time.

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Recruiting
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PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tim Bruns, Ph.D. principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04384172, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.