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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

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Conditions

Female Sexual Dysfunction

Locations

University of Michigan

Ann Arbor, Michigan 48109

United States