Effect of Peripheral Neuromodulation on Vaginal Blood Flow

University of Michigan

Status: Completed

Conditions: Spinal Cord Injuries; Female Sexual Dysfunction

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04384172

HUM00148746

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 9 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Non-dysfunction participants, no spinal cord injury

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

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

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Inclusion Criteria:

• 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
• 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Tibial nerve stimulation then Genital nerve stimulation

Experimental group

Description:

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

Treatment:

Device: Transcutaneous electrical nerve stimulation - Genital Nerve

Device: Transcutaneous electrical nerve stimulation - Tibial Nerve

Genital nerve stimulation then Tibial nerve stimulation

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous electrical nerve stimulation - Genital Nerve

Device: Transcutaneous electrical nerve stimulation - Tibial Nerve