Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2025-10-15
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nerve Stimulation only
Pre-menopausal women and post-menopausal women will be recruited. Individuals in this group will only perform dorsal genital nerve stimulation.
Electrical Stimulation
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.
Nerve Stimulation and Vibration
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.
Electrical Stimulation
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 vibrator
Subjects will use a smart vibrator at home twice a week during the study. The Lioness smart vibrator records physiological responses during use.
Vibration only
Pre-menopausal women and post-menopausal women will be recruited. Individuals in this group will only use a smart vibrator.
Smart vibrator
Subjects will use a smart vibrator at home twice a week during the study. The Lioness smart vibrator records physiological responses during use.
Interventions
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Electrical Stimulation
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 vibrator
Subjects will use a smart vibrator at home twice a week during the study. The Lioness smart vibrator records physiological responses during use.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
FEMALE
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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Timothy Bruns
Associate Professor of Biomedical Engineering
Principal Investigators
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Tim Bruns, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Priyanka Gupta, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Yike Liu
Role: primary
Other Identifiers
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HUM00265573
Identifier Type: -
Identifier Source: org_study_id