Female Sexual DysfunctionNCT06932302
At-Home Neuromodulation for Female Sexual Dysfunction
A study testing Electrical Stimulation and Smart vibrator in people with Female Sexual Dysfunction, run by University of Michigan at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Female Sexual Dysfunction
- What is being tested?
- Electrical Stimulation and Smart vibrator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Yike Liu, 734-647-8568, yikel@umich.edu
Tim Bruns, PhD
About this study
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.
- Conditions
- Female Sexual Dysfunction
- Being tested
- Electrical Stimulation, Smart vibrator
- Keywords
- dorsal genital nerve stimulation, neuromodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical StimulationDevice
Also called UCon patch system
Electrical 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 vibratorDevice
Subjects will use a smart vibrator at home twice a week during the study. The Lioness smart vibrator records physiological responses during use.
| Study group | Role | What they receive |
|---|---|---|
| Nerve Stimulation only | Experimental | Pre-menopausal women and post-menopausal women will be recruited. Individuals in this group will only perform dorsal genital nerve stimulation. Receives: Device: Electrical Stimulation |
| Nerve Stimulation and Vibration | Experimental | Pre-menopausal women and post-menopausal women will be recruited. Individuals in this group will perform dorsal genital nerve stimulation and use a smart vibrator. Receives: Device: Electrical Stimulation; Device: Smart vibrator |
| Vibration only | Active comparator | Pre-menopausal women and post-menopausal women will be recruited. Individuals in this group will only use a smart vibrator. Receives: Device: Smart vibrator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of dorsal genital nerve stimulation (DGS) sessions performed
Measured: Approximately day 22
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.
Measured: Up to week 9
Secondary outcomes (2)
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.
Measured: Baseline and approximately day 22
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.
Measured: Up to week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start15 Oct 2025
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Bruns, University of Michigan
- Investigators
- Tim Bruns, PhD, Principal investigator, University of MichiganPriyanka Gupta, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932302
- Sponsor's protocol ID
- HUM00265573
- Status last verified
- Dec 2025
- First submitted
- 9 Apr 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- At-Home Neuromodulation for Female Sexual Dysfunction
- ClinicalTrials.gov ID
- NCT06932302
- Acronym / sponsor ID
- HUM00265573
- Conditions
- Female Sexual Dysfunction
- Keywords
- dorsal genital nerve stimulation, neuromodulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nerve Stimulation only | Experimental | Device: Electrical StimulationPre-menopausal women and post-menopausal women will be recruited. Individuals in this group will only perform dorsal genital nerve stimulation. |
| Nerve Stimulation and Vibration | Experimental | Device: Electrical Stimulation, Device: Smart vibratorPre-menopausal women and post-menopausal women will be recruited. Individuals in this group will perform dorsal genital nerve stimulation and use a smart vibrator. |
| Vibration only | Active comparator | Device: Smart vibratorPre-menopausal women and post-menopausal women will be recruited. Individuals in this group will only use a smart vibrator. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical StimulationAlso: UCon patch systemElectrical 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. | Device | Nerve Stimulation and Vibration, Nerve Stimulation only |
| Smart vibratorSubjects will use a smart vibrator at home twice a week during the study. The Lioness smart vibrator records physiological responses during use. | Device | Nerve Stimulation and Vibration, Vibration only |
Primary outcome
Number of dorsal genital nerve stimulation (DGS) sessions performed
Time frame: Approximately day 22
Number of related adverse events
Time frame: Up to week 9
Study-related AEs include incidents such as device zapping, skin irritation, back cramps, or falls due to sitting for 30 minutes of stimulation.
2 secondary outcomes
Change in Female Sexual Function Index (FSFI) total scores
Time frame: Baseline and approximately day 22
The Patient Global Impression of Change (PGIC) survey score
Time frame: Up to week 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tim Bruns, PhD principal investigator
University of Michigan
Priyanka Gupta, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Stimulation and Smart vibrator in people with Female Sexual Dysfunction, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yike Liu (734-647-8568, yikel@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of dorsal genital nerve stimulation (DGS) sessions performed (time frame: Approximately day 22). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.