20 Participants NeededMy employer runs this trial

Vibratory Genital Nerve Stimulation for Female Sexual Dysfunction

SC
Overseen ByStudy Coordinator
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Samuel Cramer
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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

Are You a Good Fit for This Trial?

This trial is for adult women who have had a spinal cord injury and are experiencing sexual dysfunction. Participants should be able to attend clinic visits and use a vibration device at home as instructed.

Inclusion Criteria

I am a cisgender woman between 18 and 65 years old.
I have problems with sexual function, such as arousal or orgasm.
Have a chronic (> 1 year) spinal cord injury
See 3 more

Exclusion Criteria

I cannot use the Lioness device by myself because of physical limitations.
Are currently pregnant or attempting to become pregnant
I have had a urinary, vaginal, or genital skin infection in the past 3 months.
See 4 more

What Are the Treatments Tested in This Trial?

Interventions

  • Vibratory Genital Nerve Stimulation (vGNS)

Trial Overview

The study tests whether using vibratory genital nerve stimulation (vGNS) can improve sexual function in women with spinal cord injuries. It involves both clinic assessments and regular at-home use of a vibration device over 12 weeks.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Active vibratory genital nerve stimulation (vGNS)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Samuel Cramer

Lead Sponsor