Recruiting

DGS

Sponsor:

University of Michigan

Code:

NCT06932302

Conditions

Female Sexual Dysfunction

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Electrical Stimulation

Smart vibrator

Study Details

Brief 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 symptoms in premenopausal and postmenopausal women. Some subjects will use a smart vibrator for comparison to DGS.

Conditions

Female Sexual Dysfunction

Study ID

NCT06932302

Start date

Oct 15, 2025

Status verified date

Dec, 2025

Completion date

Nov, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Yike Liu

734-647-8568yikel@umich.edu

Tim Bruns, PhD

734-647-8727bruns@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Yike Liu

734-647-8568yikel@umich.edu

Principal Investigator:

Tim Bruns, PhD

More Information

Sponsor

University of Michigan

Last update posted

Dec 23, 2025

Last verified

Dec, 2025

Keywords

  • dorsal genital nerve stimulation
  • neuromodulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2025-12-23.