NCT04384172

Effect of Peripheral Neuromodulation on Vaginal Blood Flow

Completed NA Results posted Last updated 12 November 2025

What this trial tests

NA trial testing Transcutaneous electrical nerve stimulation - Tibial Nerve in Female Sexual Dysfunction in 9 participants. Completed in 15 March 2022.

Timeline

11 November 2020

Primary endpoint
15 March 2022

15 March 2022

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	9
Start date	11 November 2020
Primary completion	15 March 2022
Estimated completion	15 March 2022
Sites	1 location across United States

Drugs / interventions tested

• Transcutaneous electrical nerve stimulation - Tibial Nerve
• Transcutaneous electrical nerve stimulation - Genital Nerve

Conditions studied

• Female Sexual Dysfunction — all drugs for Female Sexual Dysfunction →
• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →

Sponsor

University of Michigan

Who can join

18 and older, female only, with Female Sexual Dysfunction or Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change in Average Vaginal Pulse Amplitude (VPA) During Stimulation From the Average Baseline Value Primary · 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.

Group	Value	95% CI
Tibial Nerve Stimulation	3.3	± 14.2
Genital Nerve Stimulation	3.5	± 26.7

Percent Change in Heart Rate After Stimulation From Baseline Secondary · 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)

Group	Value	95% CI
Tibial Nerve Stimulation	-6.7	± 7.1
Genital Nerve Stimulation	6.0	± 13.2

Percent Change in Mean Arterial Blood Pressure During Stimulation From Baseline Secondary · 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.

Group	Value	95% CI
Tibial Nerve Stimulation	2.3	± 4.8
Genital Nerve Stimulation	5.6	± 13.4

Change in Subjective Arousal After Stimulation Secondary · 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.

Group	Value	95% CI
Tibial Nerve Stimulation	0.5	± 1.2
Genital Nerve Stimulation	1.1	± 1.0

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Short-Term Dorsal Genital Nerve Stimulation Increases Subjective Arousal in Women With and Without Spinal Cord Injury: A Preliminary Investigation.
   Bottorff EC, Gupta P, Ippolito GM, Moore MB, et al · · 2024 · cited 6× · PMID 38573280 · DOI 10.1016/j.neurom.2024.02.004