At-Home Neuromodulation for Female Sexual Dysfunction

NCT06932302 | Recruiting

• 1 other identifier: HUM00265573
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

dorsal genital nerve stimulation; neuromodulation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Female Sexual Function Index (FSFI) total scores

  Baseline and approximately day 22

• The Patient Global Impression of Change (PGIC) survey score

  Up to week 9

Study Arms (3)

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.

Device: Electrical Stimulation

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.

Device: Electrical Stimulation; Device: Smart vibrator

Vibration only

ACTIVE COMPARATOR

Pre-menopausal women and post-menopausal women will be recruited. Individuals in this group will only use a smart vibrator.

Device: Smart vibrator

Interventions

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.

Nerve Stimulation and Vibration; Vibration only

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.

Also known as: UCon patch system

Nerve Stimulation and Vibration; Nerve Stimulation only

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Interventions

Electric Stimulation

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Tim Bruns, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Priyanka Gupta, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yike Liu

CONTACT

734-647-8568; yikel@umich.edu

Tim Bruns, PhD

CONTACT

734-647-8727; bruns@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Biomedical Engineering

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 17, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)