Status:

RECRUITING

At-Home Neuromodulation for Female Sexual Dysfunction

Lead Sponsor:

University of Michigan

Conditions:

Female Sexual Dysfunction

Eligibility:

FEMALE

18-85 years

Phase:

NA

Brief 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 subj...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

October 15 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 1 2027

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT06932302

Start Date

October 15 2025

End Date

November 1 2027

Last Update

December 23 2025

Active Locations (1)

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1

University of Michigan

Ann Arbor, Michigan, United States, 48109