Effect of Peripheral Neuromodulation on Vaginal Blood Flow - Study 2

NCT ID: NCT06999265

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-14
• Study Completion Date: 2024-06-05

Brief Summary

The overall purpose of this research is to improve sexual function in women with sexual dysfunction. The goal of this study is to see if either of two nerve stimulation interventions cause a short-term change in vaginal blood flow. The effect of this intervention will be compared between women who have neurogenic (spinal cord injury) or non-neurogenic dysfunction and healthy women, to reveal mechanisms underlying neural control over vaginal blood flow.

Detailed Description

This study will explore the short-term effect of tibial and genital stimulation on vaginal blood flow in healthy women, non-neurogenic women with female sexual dysfunction (FSD), and women with both FSD and spinal cord injuries (SCI). To potentially amplify any stimulation effects, this study will incorporate the use of sexually explicit films, a method that is standard in sexual function studies.

Conditions

Female Sexual Dysfunction; Female Sexual Dysfunction Due to Physical Condition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Tibial nerve stimulation, then genital nerve stimulation

Participants in this arm received tibial nerve stimulation during their first study visit. Those who returned for the second study visit then received genital nerve stimulation. Film Clip Alternation will take place during both interventions.

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.

Neutral and Erotic Film Clip Alternation

Intervention Type: BEHAVIORAL

During the testing period, participants will first view a 5-minute neutral film depicting nature scenes to allow blood flow levels to stabilize. This will be followed by a 10-minute period while the subject watches an erotic film clip for assessment of arousal responses without electrical stimulation. A 10-minute clip of the same neutral film will follow, to allow blood flow levels to return to baseline. Five minutes into this film, electrical stimulation will be resumed at the previously determined amplitude. Finally, the subject will view another 10-minute erotic film clip depicting similar sexually explicit material as the first while electrical stimulation remains on as the last sequence in the testing. Physiological arousal will be assessed with a vaginal photoplethysmography probe, yielding vaginal pulse amplitude (VPA) for analysis. Subjective arousal will be assessed with a subjective arousal questionnaire.

Genital nerve stimulation, then tibial nerve stimulation

Participants in this arm received genital nerve stimulation during their first study visit. Those who returned for the second study visit then received tibial nerve stimulation. Film Clip Alternation will take place during both interventions.

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.

Neutral and Erotic Film Clip Alternation

Intervention Type: BEHAVIORAL

During the testing period, participants will first view a 5-minute neutral film depicting nature scenes to allow blood flow levels to stabilize. This will be followed by a 10-minute period while the subject watches an erotic film clip for assessment of arousal responses without electrical stimulation. A 10-minute clip of the same neutral film will follow, to allow blood flow levels to return to baseline. Five minutes into this film, electrical stimulation will be resumed at the previously determined amplitude. Finally, the subject will view another 10-minute erotic film clip depicting similar sexually explicit material as the first while electrical stimulation remains on as the last sequence in the testing. Physiological arousal will be assessed with a vaginal photoplethysmography probe, yielding vaginal pulse amplitude (VPA) for analysis. Subjective arousal will be assessed with a subjective arousal questionnaire.

Interventions

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

Neutral and Erotic Film Clip Alternation

During the testing period, participants will first view a 5-minute neutral film depicting nature scenes to allow blood flow levels to stabilize. This will be followed by a 10-minute period while the subject watches an erotic film clip for assessment of arousal responses without electrical stimulation. A 10-minute clip of the same neutral film will follow, to allow blood flow levels to return to baseline. Five minutes into this film, electrical stimulation will be resumed at the previously determined amplitude. Finally, the subject will view another 10-minute erotic film clip depicting similar sexually explicit material as the first while electrical stimulation remains on as the last sequence in the testing. Physiological arousal will be assessed with a vaginal photoplethysmography probe, yielding vaginal pulse amplitude (VPA) for analysis. Subjective arousal will be assessed with a subjective arousal questionnaire.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

All Participants

• All participants will need internet access to complete the initial surveys and the diaries.

Non-dysfunction participants

• Adult (over 18 years old) cis-gender female
• Neurologically stable
• Sexually active at least once per month
• Able to understand consent and communicate effectively with research team

Non-SCI dysfunction participants

• Adult (over 18 years old) cis-gender female
• Neurologically stable
• Sexually active at least once per month
• 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 3
• Able to understand consent and communicate effectively with research team

Spinal cord injured participants

• Adult (over 18 years old) cis-gender female
• Clinically diagnosed spinal cord injury (Impairment score A-B) at vertebral level within C6-T10 at least six months prior or clinically diagnosed spinal cord injury (Impairment score 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

Non-dysfunction participants:

• Male
• Pregnancy or planning to become pregnant during study period
• Sexual dysfunction, per short-form FSFI score below 19
• Lubrication difficulties, per short-form FSFI lubrication subdomain score below or equal to 4, or per investigator's discretion
• 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 or defibrillator
• Currently has or tested positive in the last 14 days for COVID-19 or is symptomatic for COVID-19

Non-SCI dysfunction participants:

• Male
• Pregnancy or planning to become pregnant during study period
• 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 or defibrillator
• Currently has or tested positive in the last 14 days for COVID-19 or is symptomatic for COVID-19

Spinal cord injured participants:

• Male
• Spinal cord injury at or above C5 level (C1-C5) if Impairment score A or B, or spinal cord injury at or above C3 level (C1-C3) if Impairment score 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

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

Timothy Bruns

Associate Professor of Biomedical Engineering, Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tim Bruns, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Priyanka Gupta, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM00148746-b

Identifier Type: -

Identifier Source: org_study_id