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Completed

NCT Number: NCT04384172

Effect of Peripheral Neuromodulation on Vaginal Blood Flow

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.

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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

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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.

  3. 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.

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 12, 2020
Registry last updated
Nov 12, 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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