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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Electrical Stimulation
DeviceElectrical stimulation of the dorsal genital nerve will be accomplished using the UCon system and patch electrodes developed by InnoCon. The UCon system includes a programmable control unit; leads that connect to the control unit and electrodes; a silicone surface electrode; a reference electrode; and a remote control for quick on and off toggling of stimulation.
Smart vibrator
DeviceSubjects will use a smart vibrator at home twice a week during the study. The Lioness smart vibrator records physiological responses during use.
Treatment groups
24 Participants
are divided into 3 treatment groupsGroup A: Nerve Stimulation onlyExperimental treatment 1 intervention
Group B: Nerve Stimulation and VibrationExperimental treatment 2 interventions
Group C: Vibration onlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of dorsal genital nerve stimulation (DGS) sessions performed
Time frame
Approximately day 222
Number of related adverse events
Study-related AEs include incidents such as device zapping, skin irritation, back cramps, or falls due to sitting for 30 minutes of stimulation.
Time frame
Up to week 9Secondary outcomes
1
Change in Female Sexual Function Index (FSFI) total scores
The FSFI is a 19-question survey assessing sexual function in 6 different domains (desire, arousal, lubrication, orgasm, satisfaction, and pain). Each question asks subjects to rate an aspect of their sexual function on a scale from 0 or 1 to 5, depending on the question. The total score for each subdomain is multiplied by a factor so that the maximum score is 6. The total score is out of 36, with the cutoff score for overall dysfunction being 26.55. Subdomain scores of 3 or less indicate dysfunction in the respective subdomain. The FSFI will be conducted before the first study visit and again within one week after completion of the at-home stimulation period in order to see if scores have changed over the course of the treatment.
Time frame
Baseline and approximately day 222
The Patient Global Impression of Change (PGIC) survey score
The Patient Global Impression of Change (PGIC) is a 1-question survey asking patients to describe the change in their condition with a number from 1 to 7. Each number is paired with a description, where 1 represents "No change (or condition is worse)" and 7 represents "A great deal better, and a considerable improvement that has made all the difference". The PGIC will be administered within one week after completion of at-home stimulation, and again 1 month later in order to assess the patient's perception of their change in symptoms.
Time frame
Up to week 9Sponsors and contacts
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Source ClinicalTrials.gov