At-Home Neuromodulation for Female Sexual Dysfunction

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT06932302
Status
Recruiting
Apply to this trial

Conditions

  • Female Sexual Dysfunction

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Oct 15, 2025
Status verified
Dec 2025
Primary completion
Oct 31, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nerve Stimulation only
    Pre-menopausal women and post-menopausal women will be recruited. Individuals in this group will only perform dorsal genital nerve stimulation.
  • Experimental: 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.
  • Active Comparator: Vibration only
    Pre-menopausal women and post-menopausal women will be recruited. Individuals in this group will only use a smart vibrator.

Primary Outcome Measure

Number of dorsal genital nerve stimulation (DGS) sessions performed [ Time Frame: Approximately day 22 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Yike Liu
[email protected]
734-647-8568
Tim Bruns, PhD (PRINCIPAL_INVESTIGATOR)
Priyanka Gupta, MD (SUB_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By research site
University of Michigan· Ann Arbor, MI

Related Studies