NCT06932302NARecruiting
At-Home Neuromodulation for Female Sexual Dysfunction
University of Michigan
Start Date
10/15/2025
Completion Date
11/1/2027
Summary
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.
Eligibility Criteria
Age Range: 18 years to 85 years
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.
Interventions
DEVICE
Electrical Stimulation
DEVICE
Smart vibrator
Conditions
Female Sexual Dysfunction
Locations
University of Michigan
Ann Arbor, Michigan 48109
United States