N/A
N=9
Effect of Peripheral Neuromodulation on Vaginal Blood Flow
Female Sexual Dysfunction · Spinal Cord Injuries
Bottom Line
View on ClinicalTrials.gov: NCT04384172 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Percent Change in Average Vaginal Pulse Amplitude (VPA) During Stimulation From the Average Baseline Value — 3.3; 3.5 Percent change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcutaneous electrical nerve stimulation - Tibial Nerve (Device); Transcutaneous electrical nerve stimulation - Genital Nerve (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Michigan
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Average Vaginal Pulse Amplitude (VPA) During Stimulation From the Average Baseline Value |
3.3; 3.5 | — |
| SECONDARY Percent Change in Heart Rate After Stimulation From Baseline |
-6.7; 6.0 | — |
| SECONDARY Percent Change in Mean Arterial Blood Pressure During Stimulation From Baseline |
2.3; 5.6 | — |
| SECONDARY Change in Subjective Arousal After Stimulation |
0.5; 1.1 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04384172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.