Effect of Peripheral Neuromodulation on Vaginal Blood Flow

NCT04384172 | Completed Results FDA Device

• 1 other identifier: HUM00148746
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Female Sexual Dysfunction; Spinal Cord Injuries

Keywords

peripheral neuromodulation; stimulation; vaginal blood flow

Outcome Measures

Primary Outcomes (1)

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

  VPA will be measured by a vaginal plethysmography transducer. A sensor placed in the vagina will measure changes in blood flow.

  Test baseline (approximately minute 0) up to Test completion (approximately minute 60)

Secondary Outcomes (3)

• Percent Change in Heart Rate After Stimulation From Baseline

  Test baseline (approximately minute 0) up to Test completion (approximately minute 60)

• Percent Change in Mean Arterial Blood Pressure During Stimulation From Baseline

  Test baseline (approximately minute 0) up to Test completion (approximately minute 60)

• Change in Subjective Arousal After Stimulation

  Test baseline (approximately minute 0) up to Test completion (approximately minute 60)

Study Arms (2)

Tibial nerve stimulation then Genital nerve stimulation

EXPERIMENTAL

Participants who began the study with the tibial nerve stimulation and then proceeded to genital nerve stimulation Electrical stimulation applied to target the tibial nerve on one leg, with electrodes above the malleolus and on the bottom of the foot

Device: Transcutaneous electrical nerve stimulation - Tibial Nerve; Device: Transcutaneous electrical nerve stimulation - Genital Nerve

Genital nerve stimulation then Tibial nerve stimulation

EXPERIMENTAL

Participants who began the study with the genital nerve stimulation and then proceeded to tibial nerve stimulation Electrical stimulation applied to target the genital nerve, with electrodes on either side of the clitoris.

Device: Transcutaneous electrical nerve stimulation - Tibial Nerve; Device: Transcutaneous electrical nerve stimulation - Genital Nerve

Interventions

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

Genital nerve stimulation then Tibial nerve stimulation; Tibial nerve stimulation then Genital nerve stimulation

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.

Genital nerve stimulation then Tibial nerve stimulation; Tibial nerve stimulation then Genital nerve stimulation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cis-gender female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Michigan: lead
• International Society for the Study of Women's Sexual Health: collaborator
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Zimmerman LL, Gupta P, O'Gara F, Langhals NB, Berger MB, Bruns TM. Transcutaneous Electrical Nerve Stimulation to Improve Female Sexual Dysfunction Symptoms: A Pilot Study. Neuromodulation. 2018 Oct;21(7):707-713. doi: 10.1111/ner.12846. Epub 2018 Sep 3.

  PMID: 30247794 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Tim Bruns
• Organization: University of Michigan

bruns@umich.edu

734-647-8727

Study Officials

• Tim Bruns, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Biomedical Engineering, Medical School

Model Details: Participants were randomized to one arm and completed the other arm 1-5 months later.

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 12, 2020
• Study Start: November 11, 2020
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: November 12, 2025
• Results First Posted: November 12, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)