Effect of Peripheral Neuromodulation on Vaginal Blood Flow

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Peripheral Neuromodulation on Vaginal Blood Flow

Conditions
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Female Sexual Dysfunction, Spinal Cord Injuries

Intervention / Treatment
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* Device: Tibial e-stim
* Device: Genital e-stim


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tibial e-stim followed by genital e-stim<br>Tibial e-stim followed by genital e-stim | Device: Tibial e-stim<br>* For tibial nerve stimulation, the two electrodes will be placed just above the medial malleolus and the ipsilateral calcaneus on one leg near the ankle.<br>Device: Genital e-stim<br>* For dorsal genital nerve stimulation, two electrodes will be placed on either side of the clitoris.<br>|
| Experimental: Genital e-stim followed by tibial e-stim<br>Genital e-stim followed by tibial e-stim | Device: Tibial e-stim<br>* For tibial nerve stimulation, the two electrodes will be placed just above the medial malleolus and the ipsilateral calcaneus on one leg near the ankle.<br>Device: Genital e-stim<br>* For dorsal genital nerve stimulation, two electrodes will be placed on either side of the clitoris.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum change in vaginal pulse amplitude (VPA) from the average baseline value | VPA will be measured by a vaginal plethysmography transducer | Test baseline (approximately minute 0) up to Test completion (approximately minute 60) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum change in heart rate from baseline | 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) | Test baseline (approximately minute 0) up to Test completion (approximately minute 60) | 
| Maximum change in blood pressure from baseline | 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. | Test baseline (approximately minute 0) up to Test completion (approximately minute 60) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral neuromodulation, stimulation, vaginal blood flow