At-Home Neuromodulation for Female Sexual Dysfunction

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 Overview

• Status: Recruiting
• Conditions: Female Sexual Dysfunction
• Intervention / Treatment: Device: Electrical Stimulation; Device: Smart vibrator

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yike Liu; Phone Number: 734-647-8568; Email: yikel@umich.edu
• Study Contact Backup: Name: Tim Bruns, PhD; Phone Number: 734-647-8727; Email: bruns@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Yike Liu; Phone Number: 734-647-8568; Email: yikel@umich.edu
      • Principal Investigator: Tim Bruns, PhD
      • Sub-Investigator: Priyanka Gupta, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.; Other Names: UCon patch system
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.	Device: 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.; Other Names: UCon patch system; Device: 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.
Active Comparator: Vibration only; Pre-menopausal women and post-menopausal women will be recruited. Individuals in this group will only use a smart vibrator.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Tim Bruns, PhD, University of Michigan; Principal Investigator: Priyanka Gupta, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: April 9, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: neuromodulation; dorsal genital nerve stimulation
• Additional Relevant MeSH Terms: Investigative Techniques; Physical Stimulation; Electric Stimulation
• Other Study ID Numbers: HUM00265573

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes