At-Home Neuromodulation for Female Sexual Dysfunction
University of Michigan
24 participants
Oct 15, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria9
- 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.
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Interventions
Electrical stimulation of the dorsal genital nerve will be accomplished using the UCon system and patch electrodes developed by InnoCon. The UCon system includes a programmable control unit; leads that connect to the control unit and electrodes; a silicone surface electrode; a reference electrode; and a remote control for quick on and off toggling of stimulation.
Subjects will use a smart vibrator at home twice a week during the study. The Lioness smart vibrator records physiological responses during use.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06932302