Actively Recruiting
At-Home Neuromodulation for Female Sexual Dysfunction
Led by University of Michigan · Updated on 2025-12-23
24
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of non-invasive dorsal genital nerve stimulation (DGS) for treating female sexual dysfunction (FSD) in premenopausal and postmenopausal women. This pilot study aims to see if women with FSD can follow an at-home treatment plan and if DGS can improve symptoms related to sexual arousal. Some participants will also use a smart vibrator to compare results. Participants will be randomly assigned to one of three groups: DGS only, DGS combined with a smart vibrator, or smart vibrator only. The DGS treatment uses a device called the UCon system with patch electrodes to deliver electrical stimulation to the dorsal genital nerve. The smart vibrator records physiological responses during use and is used twice a week at home. Participants will attend sessions at Michigan Medicine at the beginning and end of the study. Researchers will track how many DGS sessions are completed and monitor any related adverse events over about nine weeks. They will also measure changes in sexual function using the Female Sexual Function Index and assess overall patient impressions of change. The study lasts roughly three weeks for initial measurements with follow-up through week nine.
CONDITIONS
Brief Title
At-Home Neuromodulation for Female Sexual Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 3 weeks
Participants use devices at home for neuromodulation and/or vibration therapy as assigned by their group.
Twice weekly sessions at home
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
Y
Yike Liu
T
Tim Bruns, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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