Vibratory Genital Nerve Stimulation (vGNS) to Treat Female Sexual Dysfunction (FSD) After Spinal Cord Injury (SCI)

ConditionsSpinal Cord Injury Sexual Dysfunction Female

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-65

SponsorSamuel Cramer

About this trial

The goal of this clinical trial is to learn if vibratory genital nerve stimulation (vGNS) can improve sexual function in women with spinal cord injury. The main question it aims to answer is:

Does acute vGNS increase genital blood flow during a standardized sexual arousal assessment, as measured by laser speckle contrast imaging?

Participants will:

Complete a baseline in-clinic visit including two sexual arousal assessments with a vGNS session in between, while genital blood flow is measured using a non-invasive imaging device

Use a vibration device at home twice weekly for 12 weeks

Complete questionnaires about sexual function at baseline, during the home phase, and at a 12-week follow-up visit

Attend a follow-up in-clinic visit repeating the baseline assessments

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be cisgender women aged 18 to 65 years (current study is scoped specifically to cisgender female anatomy)

Have a chronic (> 1 year) spinal cord injury

Self-report impaired sexual function (e.g., arousal, lubrication, orgasm)

Be sexually active or report a desire for sexual activity

Disqualifiers

Are currently pregnant or attempting to become pregnant

Have a history of autonomic dysreflexia (AD) triggered by sexual activity or genital stimulation

Have undergone pelvic reconstructive surgery

Report being unable to independently position and operate the Lioness device due to motor or anatomical limitations

Trial design

Design model

Single group

Treatments tested in this trial

Vibratory genital nerve stimulation
Device
vGNS will be administered in this study via the Lioness vibrator

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Active vibratory genital nerve stimulation (vGNS)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change in genital blood perfusion during acute vibratory genital nerve stimulation (vGNS)

Change in LSCI-measured genital blood perfusion during a standardized psychogenic sexual arousal assessment (PSAA) before and after an in-clinic vGNS block in women with spinal cord injury.

Time frame

2-3 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Samuel Cramer

Lead sponsor

Hennepin Healthcare Research Institute

Sponsor institution

Source ClinicalTrials.gov

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