Effect of Peripheral Neuromodulation on Vaginal Blood Flow

Not Applicable

Completed

Brief Summary: The researchers want to see if nerve stimulation interventions cause a 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Tibial e-stim followed by genital e-stim	Tibial e-stim	Tibial e-stim followed by genital e-stim
Genital e-stim followed by tibial e-stim	Tibial e-stim	Genital e-stim followed by tibial e-stim
Genital e-stim followed by tibial e-stim	Genital e-stim	Genital e-stim followed by tibial e-stim
Tibial e-stim followed by genital e-stim	Genital e-stim	Tibial e-stim followed by genital e-stim

Primary Outcome Measures

Name	Time	Method
Maximum change in vaginal pulse amplitude (VPA) from the average baseline value	Test baseline (approximately minute 0) up to Test completion (approximately minute 60)	VPA will be measured by a vaginal plethysmography transducer

Secondary Outcome Measures

Name	Time	Method
Maximum change in blood pressure from baseline	Test baseline (approximately minute 0) up to Test completion (approximately minute 60)	A blood pressure monitor will be placed on the participant's arm, hand, or chest (as is appropriate per monitor) to monitor off-target autonomic responses.
Maximum change in heart rate from baseline	Test baseline (approximately minute 0) up to Test completion (approximately minute 60)	A heart rate monitor (e.g. electrocardiogram or pulse oximetry) will be placed on the participant's arm, hand, or chest (as is appropriate per monitor)