Effect of Peripheral Neuromodulation on Vaginal Blood Flow - Study 2

University of Michigan

Status: Completed

Conditions: Female Sexual Dysfunction Due to Physical Condition; Female Sexual Dysfunction

Treatments: Behavioral: Neutral and Erotic Film Clip Alternation; Device: Transcutaneous electrical nerve stimulation - Genital Nerve; Device: Transcutaneous electrical nerve stimulation - Tibial Nerve

Study type: Interventional

Funder types: Other

Identifiers

NCT06999265

HUM00148746-b

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Tibial nerve stimulation, then genital nerve stimulation

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous electrical nerve stimulation - Tibial Nerve

Behavioral: Neutral and Erotic Film Clip Alternation

Device: Transcutaneous electrical nerve stimulation - Genital Nerve

Genital nerve stimulation, then tibial nerve stimulation

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous electrical nerve stimulation - Tibial Nerve

Behavioral: Neutral and Erotic Film Clip Alternation

Device: Transcutaneous electrical nerve stimulation - Genital Nerve