At-home dorsal genital nerve stimulation for female sexual dysfunction
At-Home Neuromodulation for Female Sexual Dysfunction
NA · University of Michigan · NCT06932302
This pilot will test whether regular at-home dorsal genital nerve stimulation or use of a smart vibrator can help premenopausal and postmenopausal women with female sexual dysfunction improve arousal symptoms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | University of Michigan (other) |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06932302 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Women with female sexual dysfunction who have FSFI scores of 26.55 or less and a score of 3 or less on lubrication, arousal, or orgasm subdomains, who are sexually active, English-speaking, able to attend baseline and final visits at Michigan Medicine, and able to follow the home treatment protocol.
Not a fit: People who are not sexually active, pregnant or planning pregnancy, have neurological disorders affecting pelvic function, implanted neurostimulators, or skin conditions predisposing to electrode sensitivity are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could offer a noninvasive, at-home option to improve sexual arousal and related symptoms for women with female sexual dysfunction.
How similar studies have performed: Some small studies of pelvic or genital neuromodulation have suggested benefit for sexual function, but at-home dorsal genital nerve stimulation is a relatively novel and not widely tested approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ann Arbor, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Female Sexual Dysfunction, dorsal genital nerve stimulation, neuromodulation