NCT07870642NARecruiting

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

Samuel Cramer

Start Date

9/1/2026

Completion Date

7/1/2028

Summary

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

Age Range: 18 years to 65 years

Inclusion Criteria: * 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 * Be able to place and operate the Lioness device independently * Be able to provide informed consent and participate in study procedures Exclusion Criteria: * 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 * Have a recent history of urinary tract infection, vaginal infection, or active genital skin condition within the last 3 months * Have implanted medical devices or cardiovascular instability that contraindicates vibratory stimulation (e.g., pacemaker) * Are currently taking medications that may influence sexual arousal response in the opinion of the investigator

Interventions

DEVICE

Vibratory genital nerve stimulation

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Conditions

Spinal Cord InjurySexual Dysfunction Female

Locations

Hennepin Healthcare Research Institute

Minneapolis, Minnesota 55415

United States