At-Home Neuromodulation for Female Sexual Dysfunction
ConditionFemale Sexual Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-85
SponsorUniversity of Michigan
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Electrical Stimulation
- Smart vibrator
Treatment groups
24 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov