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

20 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Dorsal Genital Nerve Stimulation for Female Sexual Dysfunction?

Research shows that electrical stimulation of the dorsal genital nerve can increase sexual arousal in women, including those with spinal cord injuries. Additionally, similar nerve stimulation methods have been used to improve symptoms of female sexual dysfunction, suggesting potential benefits for this treatment. ^{1 2 3 4 5}

Is dorsal genital nerve stimulation safe for humans?

Studies on dorsal genital nerve stimulation, including its use for female sexual dysfunction and defecatory urgency, have not reported significant safety concerns or adverse effects, suggesting it is generally safe for humans. ^{1 2 3 4 6}

How is dorsal genital nerve stimulation treatment different from other treatments for female sexual dysfunction?

Dorsal genital nerve stimulation is unique because it uses electrical impulses to directly stimulate nerves associated with sexual arousal, which is different from other treatments that may focus on hormonal or psychological approaches. This method has shown promise in increasing sexual arousal in women, including those with spinal cord injuries, by targeting specific nerve pathways. ^{1 2 4 7 8}

What is the purpose of this trial?

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.

Research Team

Tim Bruns, PhD

Principal Investigator

University of Michigan

Priyanka Gupta, MD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

Group I: Stimulation Experimental Treatment 1 Intervention

Pre-menopausal women and post-menopausal women will be recruited.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Acute dorsal genital nerve stimulation increases subjective arousal in women with and without spinal cord injury. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Nerve Stimulation to Improve Female Sexual Dysfunction Symptoms: A Pilot Study. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

New insights into restless genital syndrome: static mechanical hyperesthesia and neuropathy of the nervus dorsalis clitoridis. [2009]

4. Italy pubmed.ncbi.nlm.nih.gov

Electrical stimulation of the dorsal clitoral nerve in the treatment of idiopathic defecatory urgency. A pilot study. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Tibial Nerve Stimulation to Drive Genital Sexual Arousal in an Anesthetized Female Rat. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Designing drugs for the treatment of female sexual dysfunction. [2013]

7. Ireland pubmed.ncbi.nlm.nih.gov

Pudendal SEP and bulbocavernosus reflex in women. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Immediate and Long-Term Effects of Tibial Nerve Stimulation on the Sexual Behavior of Female Rats. [2023]