Neuromodulation for Female Sexual Dysfunction

Overseen By Tim Bruns, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Not sexually active, Pregnant, Neurological disorder, Bladder dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called dorsal genital nerve stimulation (DGS) to assist women with female sexual dysfunction (FSD), which includes difficulties with arousal, lubrication, and orgasm. The study aims to determine if women can use this treatment at home and whether it improves their symptoms. Participants will be divided into groups: one using only DGS, another using both DGS and a smart vibrator, and one using only the vibrator. Women who experience issues such as arousal or orgasm problems, beyond just low desire, and can adhere to the study plan may be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for FSD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.

What prior data suggests that dorsal genital nerve stimulation is safe for treating female sexual dysfunction?

Research shows that dorsal genital nerve stimulation (DGS) is generally well-tolerated. Studies on this treatment for female sexual dysfunction and other conditions have not identified major safety concerns. Serious side effects are rare, with no major adverse events linked to DGS. So far, the treatment appears safe for humans. Participants in past research did not experience serious problems, suggesting that the treatment is safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the neuromodulation techniques being explored for female sexual dysfunction because they offer a novel approach compared to traditional options like hormone therapy and counseling. Dorsal genital nerve stimulation directly targets the nervous system to potentially enhance sexual response, providing a unique mechanism of action. Additionally, the combination of nerve stimulation with a smart vibrator might offer synergistic effects, promoting both nerve and physical stimulation in a way that current treatments don't. These innovative approaches could provide quicker and more direct relief, addressing both physiological and psychological aspects of the condition.

What evidence suggests that this trial's treatments could be effective for female sexual dysfunction?

Research has shown that stimulating the dorsal genital nerve (DGNS) can increase feelings of sexual arousal in women, including those with sexual dysfunction. Studies have found that DGNS can enhance these feelings, but its impact on physical arousal remains less clear. In this trial, participants will be assigned to different treatment arms: one group will receive only DGNS, another will receive both DGNS and vibration, and a third group will use vibration only. Therapies like DGNS, which involve nerve stimulation, have also helped with sexual function in other conditions, such as bladder issues. Some evidence suggests that combining nerve stimulation with vibration might strengthen these effects. While the findings are promising, more research is needed to fully understand the benefits for women with sexual dysfunction. ^{1 2 3 4 6}

Who Is on the Research Team?

Priyanka Gupta, MD

Principal Investigator

University of Michigan

Tim Bruns, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for premenopausal and postmenopausal women experiencing female sexual dysfunction (FSD). Participants should be able to follow an at-home treatment regimen. Specific inclusion and exclusion criteria are not detailed here.

Inclusion Criteria

Capable of speaking and understanding English

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

Exclusion Criteria

Pregnant or planning to get pregnant during the study period

Implanted with a neurostimulator for bladder or bowel function

Have a skin condition that would predispose them to sensitivity to the stimulation electrodes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo at-home dorsal genital nerve stimulation (DGS) for female sexual dysfunction

3 weeks

At-home treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Dorsal Genital Nerve Stimulation

Trial Overview The study tests non-invasive dorsal genital nerve stimulation (DGS) as a regular at-home treatment for improving arousal symptoms in women with FSD. It's a pilot study, meaning it's preliminary research to see if the method is feasible and effective.

How Is the Trial Designed?

Group I: Nerve Stimulation only Experimental Treatment 1 Intervention

Pre-menopausal women and post-menopausal women will be recruited. Individuals in this group will only perform dorsal genital nerve stimulation.

Group II: Nerve Stimulation and Vibration Experimental Treatment 2 Interventions

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.

Group III: Vibration only Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

Electrical stimulation of the dorsal genital nerve (DGNS) significantly increased subjective sexual arousal in women, including those with female sexual dysfunction (FSD), while tibial nerve stimulation (TNS) showed no effect.

This pilot study, which included healthy women, women with FSD, and women with spinal cord injury, suggests that DGNS may be a promising treatment option for improving sexual arousal in women with FSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute dorsal genital nerve stimulation increases subjective arousal in women with and without spinal cord injury. Bottorff, EC., Gupta, P., Ippolito, GM., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10168483/

Acute dorsal genital nerve stimulation increases subjective ... This study demonstrates that acute DGNS, but not TNS, can increase subjective arousal, but the effect of stimulation on genital arousal is inconclusive.

2. medrxiv.org medrxiv.org/content/10.1101/2023.04.24.23288935v2.full-text

Acute dorsal genital nerve stimulation increases subjective ... This study demonstrates that acute DGNS, but not TNS, can increase subjective arousal, but the effect of stimulation on genital arousal is inconclusive.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2468451124000448

Neuromodulation for the treatment of sexual dysfunction Neuromodulation therapies for bladder dysfunction often improve sexual function. Tibial nerve stimulation has good potential as a sexual dysfunction therapy.

4. neuromodulationjournal.org neuromodulationjournal.org/article/S1094-7159(24)00059-X/abstract

Short-Term Dorsal Genital Nerve Stimulation Increases ... The primary outcome measure was change in vaginal pulse amplitude (VPA) from baseline. Secondary outcome measures were changes in subjective arousal, heart rate ...

5. withpower.com withpower.com/trial/phase-female-sexual-dysfunction-fsd-3-2025-64e2c

Neuromodulation for Female Sexual Dysfunction Electrical stimulation of the dorsal genital nerve (DGNS) significantly increased subjective sexual arousal in women, including those with female sexual ...

6. sciencedirect.com sciencedirect.com/science/article/am/pii/S109471592400059X

Short-Term Dorsal Genital Nerve Stimulation Increases ... Vibration or Transcutaneous Tibial Nerve Stimulation as a Treatment for Sexual Dysfunction in Women with. Spinal Cord Injury: Study Protocol for a Randomized ...