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Effect of Peripheral Neuromodulation on Vaginal Blood Flow

NCT ID: NCT04384172

Last Updated: 2025-11-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-11

Study Completion Date

2022-03-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Female Sexual Dysfunction Spinal Cord Injuries

Keywords

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peripheral neuromodulation stimulation vaginal blood flow

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants were randomized to one arm and completed the other arm 1-5 months later.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Tibial nerve stimulation then Genital nerve stimulation

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

Group Type EXPERIMENTAL

Transcutaneous electrical nerve stimulation - Tibial Nerve

Intervention Type 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

Intervention Type 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

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.

Group Type EXPERIMENTAL

Transcutaneous electrical nerve stimulation - Tibial Nerve

Intervention Type 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

Intervention Type 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.

Interventions

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Transcutaneous electrical nerve stimulation - Tibial Nerve

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

Intervention Type DEVICE

Transcutaneous electrical nerve stimulation - Genital Nerve

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.

Intervention Type DEVICE

Eligibility Criteria

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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


* 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


* 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
* 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


* 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


* 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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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International Society for the Study of Women's Sexual Health

UNKNOWN

Sponsor Role collaborator

The Craig H. Neilsen Foundation

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Timothy Bruns

Associate Professor of Biomedical Engineering, Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tim Bruns, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 30247794 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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HUM00148746

Identifier Type: -

Identifier Source: org_study_id