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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Vibration only | Active Comparator | Pre-menopausal women and post-menopausal women will be recruited. Individuals in this group will only use a smart vibrator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrical Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of dorsal genital nerve stimulation (DGS) sessions performed | 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. | Up to week 9 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yike Liu | Contact | 734-647-8568 | yikel@umich.edu | |
| Tim Bruns, PhD | Contact | 734-647-8727 | bruns@umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tim Bruns, PhD | University of Michigan | Principal Investigator |
| Priyanka Gupta, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
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| Smart vibrator | Device | Subjects will use a smart vibrator at home twice a week during the study. The Lioness smart vibrator records physiological responses during use. |
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| 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. | Up to week 9 |