At-Home Neuromodulation for Female Sexual Dysfunction

University of Michigan

Status: Enrolling

Conditions: Female Sexual Dysfunction

Treatments: Device: Smart vibrator; Device: Electrical Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06932302

HUM00265573

Details and patient eligibility

About

This pilot study investigates the regular use of non-invasive dorsal genital nerve stimulation (DGS) for the treatment of female sexual dysfunction (FSD). The researchers aim to determine whether subjects with FSD can correctly follow an at-home treatment regimen and to demonstrate that DGS can improve FSD arousal symptoms in premenopausal and postmenopausal women. Some subjects will use a smart vibrator for comparison to DGS.

Enrollment: 24 estimated patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Capable of speaking and understanding English.
• Able to comprehend the clinical study procedures and provide informed consent.
• Identified as having female sexual dysfunction with a Female Sexual Function Index (FSFI) score of 26.55 or less and a score of 3 or less on one or more of the FSFI subdomains of lubrication, arousal, and orgasm.
• Willing and able to adhere to the study protocol
• Able to attend experimental sessions at Michigan Medicine at both the start and conclusion of the study.

Exclusion criteria

• Not currently sexually active.
• Pregnant or planning to get pregnant during the study period.
• History of a neurological disorder or impairments affecting pelvic organ function, including diagnosed with dorsal genital nerve damage, lower motor dysfunction, or other related conditions.
• Implanted with a neurostimulator for bladder or bowel function.
• Have a skin condition that would predispose them to sensitivity to the stimulation electrodes.
• Female sexual dysfunction limited solely to low desire, without issues in lubrication, arousal, or orgasm.
• Clinically diagnosed bladder dysfunction, pelvic pain, or other pelvic organ symptoms; or a score of 8 or higher on the American Urological Association Symptom Index (AUASI).
• Unable or unwilling to adhere to the study protocol
• Simultaneously participating in another research study that may affect the results of this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Nerve Stimulation only

Experimental group

Description:

Pre-menopausal women and post-menopausal women will be recruited. Individuals in this group will only perform dorsal genital nerve stimulation.

Treatment:

Device: Electrical Stimulation

Nerve Stimulation and Vibration

Experimental group

Description:

Pre-menopausal women and post-menopausal women will be recruited. Individuals in this group will perform dorsal genital nerve stimulation and use a smart vibrator.

Treatment:

Device: Electrical Stimulation

Device: Smart vibrator

Vibration only

Active Comparator group

Description:

Pre-menopausal women and post-menopausal women will be recruited. Individuals in this group will only use a smart vibrator.

Treatment:

Device: Smart vibrator