AzTrials
AzTrials

Female Sexual DysfunctionNCT06999265

Effect of Peripheral Neuromodulation on Vaginal Blood Flow - Study 2

A study testing Transcutaneous electrical nerve stimulation - Tibial Nerve, Transcutaneous electrical nerve stimulation - Genital Nerve and Neutral and Erotic Film Clip Alternation in people with Female Sexual Dysfunction and Female Sexual Dysfunction Due to Physical Condition, 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
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Transcutaneous electrical nerve stimulation - Tibial Nerve, Transcutaneous electrical nerve stimulation - Genital Nerve and Neutral and Erotic Film Clip Alternation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
14 Sep 2022to 5 Jun 2024
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

  • All Participants
  • All participants will need internet access to complete the initial surveys and the diaries.
  • Non-dysfunction participants
  • Adult (over 18 years old) cis-gender female
  • Neurologically stable
  • Sexually active at least once per month
Show all 20Show fewer
  • Able to understand consent and communicate effectively with research team
  • Non-SCI dysfunction participants
  • Adult (over 18 years old) cis-gender female
  • Neurologically stable
  • Sexually active at least once per month
  • 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 3
  • Able to understand consent and communicate effectively with research team
  • Spinal cord injured participants
  • Adult (over 18 years old) cis-gender female
  • Clinically diagnosed spinal cord injury (Impairment score A-B) at vertebral level within C6-T10 at least six months prior or clinically diagnosed spinal cord injury (Impairment score 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

  • Non-dysfunction participants:
  • Male
  • Pregnancy or planning to become pregnant during study period
  • Sexual dysfunction, per short-form FSFI score below 19
  • Lubrication difficulties, per short-form FSFI lubrication subdomain score below or equal to 4, or per investigator's discretion
  • Clinically diagnosed bladder dysfunction, pelvic pain, or other pelvic organ symptoms
Show all 28Show fewer
  • Suspected or diagnosed epilepsy
  • 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
  • Non-SCI dysfunction participants:
  • Male
  • Pregnancy or planning to become pregnant during study period
  • 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 or defibrillator
  • Currently has or tested positive in the last 14 days for COVID-19 or is symptomatic for COVID-19
  • Spinal cord injured participants:
  • Male
  • Spinal cord injury at or above C5 level (C1-C5) if Impairment score A or B, or spinal cord injury at or above C3 level (C1-C3) if Impairment score 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

Official title: Effect of Peripheral Neuromodulation on Vaginal Blood Flow

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.

Read the detailed description

This study will explore the short-term effect of tibial and genital stimulation on vaginal blood flow in healthy women, non-neurogenic women with female sexual dysfunction (FSD), and women with both FSD and spinal cord injuries (SCI). To potentially amplify any stimulation effects, this study will incorporate the use of sexually explicit films, a method that is standard in sexual function studies.

Being tested
Transcutaneous electrical nerve stimulation - Tibial Nerve, Transcutaneous electrical nerve stimulation - Genital Nerve, Neutral and Erotic Film Clip Alternation

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.

  • Neutral and Erotic Film Clip AlternationBehavioural

    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.

Study groups in NCT06999265
Study groupRoleWhat they receive
Tibial nerve stimulation, then genital nerve stimulationExperimentalParticipants in this arm received tibial nerve stimulation during their first study visit. Those who returned for the second study visit then received genital nerve stimulation. Film Clip Alternation will take place during both interventions.
Receives: Device: Transcutaneous electrical nerve stimulation - Tibial Nerve; Device: Transcutaneous electrical nerve stimulation - Genital Nerve; Behavioral: Neutral and Erotic Film Clip Alternation
Genital nerve stimulation, then tibial nerve stimulationExperimentalParticipants in this arm received genital nerve stimulation during their first study visit. Those who returned for the second study visit then received tibial nerve stimulation. Film Clip Alternation will take place during both interventions.
Receives: Device: Transcutaneous electrical nerve stimulation - Tibial Nerve; Device: Transcutaneous electrical nerve stimulation - Genital Nerve; Behavioral: Neutral and Erotic Film Clip Alternation

What is being measured

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

  1. Maximum Percent Change in Vaginal Pulse Amplitude (VPA) From the Average Baseline Value

    VPA will be measured by a vaginal plethysmography transducer that is placed in the vagina to measure changes in blood flow during the full study session.

    Overall treatment sequence:

    baseline (nature) video erotic video 1 (no treatment = "control") baseline nature video (treatment on in middle) erotic video 2 (treatment)

    The average VPA value during the baseline period will be determined. The maximum percent change in VPA during each relevant sequence as compared to the average baseline VPA will be determined for each participant.

    Measured: Up to five months

Secondary outcomes (3)

  1. Percent Change in Heart Rate 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) to measure the heart rate in beats per minute (bpm).

    The average heart rate in bpm during the baseline video will be determined. The average percent change in heart rate during each test sequence as compared to the average baseline heart rate will be determined.

    Measured: Up to five months

  2. Percent Change in Mean Arterial Blood Pressure 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.

    The mean arterial blood pressure in millimeters of mercury (mm Hg) will be calculated for a period as the diastolic pressure plus 1/3 times the difference between the systolic pressure and the diastolic pressure, following standard practice.

    The average mean arterial blood pressure will be determined for the baseline period.

    The percent change in average mean arterial blood pressure with respect to the baseline period will be determined for each test sequence.

    Measured: Up to five months

  3. Change in Subjective Arousal From Baseline

    Subjective arousal will be evaluated by participants using a five point Likert scale, where 1 being no arousal and 5 being greatest arousal. Survey will be presented to patients between every video transition (a total of 4 times). Data is presented as averages per video transition point.

    Measured: Up to five months

Timeline

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

  1. First posted31 May 2025
  2. Study start14 Sep 2022
  3. Primary completion5 Jun 2024
  4. Study completion5 Jun 2024

Resources

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
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06999265
Sponsor's protocol ID
HUM00148746-b
Status last verified
Jul 2025
First submitted
22 May 2025
Last updated
16 Jul 2025
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous electrical nerve stimulation - Tibial Nerve, Transcutaneous electrical nerve stimulation - Genital Nerve and Neutral and Erotic Film Clip Alternation in people with Female Sexual Dysfunction and Female Sexual Dysfunction Due to Physical Condition, run by University of Michigan at 1 site in United States.

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 20 inclusion and 28 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 16 Jul 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 16 Jul 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?

Maximum Percent Change in Vaginal Pulse Amplitude (VPA) From the Average Baseline Value (time frame: Up to five months). 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 NCT06999265.

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 16 Jul 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in