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Completed

NCT Number: NCT06999265

Effect of Peripheral Neuromodulation on Vaginal Blood Flow - Study 2

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
  • 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

Exclusion criteria

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
  • 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

Treatment and study plan

Transcutaneous electrical nerve stimulation - Tibial Nerve

Device

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 Nerve

Device

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 Alternation

Behavioral

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.

Primary outcomes

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

    Time frame: Up to five months

    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.

Secondary outcomes

  1. Percent Change in Heart Rate From Baseline

    Time frame: Up to five months

    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.

  2. Percent Change in Mean Arterial Blood Pressure From Baseline

    Time frame: Up to five months

    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.

  3. Change in Subjective Arousal From Baseline

    Time frame: Up to five months

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

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

Registry information

Official study title

Effect of Peripheral Neuromodulation on Vaginal Blood Flow

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 31, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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