At-home dorsal genital nerve stimulation for female sexual dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot interventional study gives participants a non-invasive dorsal genital nerve stimulation device to use at home and compares outcomes in some participants to use of a smart vibrator. Researchers will determine whether participants can correctly follow the at-home treatment regimen and will measure changes in arousal-related symptoms using validated questionnaires such as the FSFI. Participants attend in-person sessions at the University of Michigan at the beginning and end of the protocol while completing the treatment at home. The study focuses on both premenopausal and postmenopausal women meeting specific FSFI-based inclusion criteria.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Tim Bruns, PhD — University of Michigan
• Study coordinator: Yike Liu
• Email: yikel@umich.edu
• Phone: 734-647-8568

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.