Vibrator Use for Female Sexual Dysfunction

Overseen By Erin Deverdis, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Albany Medical College

Disqualifiers: Cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

84 Participants Needed

Trial Summary

What is the purpose of this trial?

Limited data exist describing the use and role of vibrators in a urogynecology population and no randomized controlled trials investigating the use of vibrators as a therapeutic tool to enhance sexual and pelvic floor function in urogynecology patients has been conducted. This study aims to evaluate the efficacy of vibrator use in improving sexual and pelvic floor function in urogynecology patients who report sexual dysfunction.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Vibrator for female sexual dysfunction?

Research shows that vibrators can help improve sexual function by increasing sexual desire and overall sexual function, and they may also help with arousal difficulties and pelvic floor issues. ^{1 2 3 4 5}

Is vibrator use safe for treating female sexual dysfunction?

Vibrators are generally considered safe for treating sexual dysfunction and enhancing sexual pleasure, but it's important to follow best practice recommendations for choosing and using them safely. Further research is needed to provide evidence-based cleaning recommendations. ^{3 4 5 6 7}

How does vibrator use as a treatment for female sexual dysfunction differ from other treatments?

Vibrator use is unique because it provides direct physical stimulation to enhance sexual pleasure and function, which can help with issues like low sexual desire and difficulty reaching orgasm. Unlike medications or other therapies, vibrators offer a non-invasive, immediate way to address sexual dysfunction by increasing blood flow and sensitivity in the genital area. ^{3 4 5 8 9}

Eligibility Criteria

This trial is for women over 18 who visit a urogynecology clinic and have been diagnosed with conditions like pelvic organ prolapse or various types of incontinence. They should score below 26.55 on the FSFI, indicating sexual dysfunction, not currently use a vibrator, be able to read/write in English, and consent to using a vibrator.

Inclusion Criteria

I am a woman, 18 or older, seeing a urogynecologist.

I am willing to use a vibrator.

Able to provide informed consent

Exclusion Criteria

I am not comfortable using or refuse to use a vibrator.

Currently using a vibrator or has used a vibrator in the past 3 months

I am unable to understand or sign the consent form.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use vibrators as a therapeutic tool to enhance sexual and pelvic floor function

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Vibrator

Trial Overview The study is testing if vibrators can help improve sexual and pelvic floor function among women experiencing sexual dysfunction related to urogynecologic issues. Participants will receive an instructional handout and use a vibrator as part of the therapy.

Participant Groups

Group I: Intervention arm Experimental Treatment 2 Interventions

Group II: Control arm Active Control 1 Intervention

Who Is Running the Clinical Trial?

Albany Medical College

Lead Sponsor

Trials

96

Recruited

12,700+

Findings from Research

The review highlights the growing recognition of female sexual dysfunction and the increasing acceptance of sex therapy as an effective treatment option.

Despite the potential of psychotherapy for addressing female sexual dysfunction, the article points out significant methodological issues in existing studies, suggesting a need for improved research standards in future investigations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychotherapy for female sexual dysfunction: a review. O'Donohue, W., Dopke, CA., Swingen, DN.[2019]

In a study of 70 women with sexual arousal and orgasm disorders, the use of a genital vibratory stimulation device led to significant improvements in sexual function and satisfaction over 3 months, as measured by the Female Sexual Function Index (FSFI).

Participants reported increased genital sensation and decreased sexual distress, with no major adverse events noted, indicating that this device is a safe and effective option for enhancing sexual health in women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of a Genital Vibratory Stimulation Device on Sexual Function and Genital Sensation. Guess, MK., Connell, KA., Chudnoff, S., et al.[2021]

Vibrators are recognized as an effective treatment for various sexual dysfunctions and can enhance sexual experiences, but there are currently no standardized best practice guidelines for their use.

A multidisciplinary team has developed recommendations focusing on safe usage and patient counseling for vibratory stimulation, highlighting the need for further research on effective counseling methods and cleaning practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genital vibration for sexual function and enhancement: best practice recommendations for choosing and safely using a vibrator. Rullo, JE., Lorenz, T., Ziegelmann, MJ., et al.[2020]

Over half of the women surveyed (52.5%) reported using vibrators, indicating that vibrator use is common and often linked to positive sexual function, including higher scores in desire, arousal, and orgasm.

Vibrator users were more likely to engage in health-promoting behaviors, such as having recent gynecologic exams and performing genital self-examinations, while most reported no significant side effects from use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and characteristics of vibrator use by women in the United States: results from a nationally representative study. Herbenick, D., Reece, M., Sanders, S., et al.[2015]

Vibratory stimulation, often associated with sex toys, has evidence supporting its use in treating various sexual dysfunctions, including erectile dysfunction, ejaculatory dysfunction, and anorgasmia.

The use of genital vibrators is positively correlated with increased sexual desire and overall sexual function, suggesting they may be beneficial for a range of sexual health issues in both men and women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genital vibration for sexual function and enhancement: a review of evidence. Rullo, JE., Lorenz, T., Ziegelmann, MJ., et al.[2020]

In a 16-week study involving over 256 women aged 21 to 65 with sexual disorders, Zestra, a topical botanical preparation, was found to be well tolerated and effective in improving sexual desire, arousal, and treatment satisfaction.

The only notable safety concern was mild-to-moderate genital burning experienced by 14.6% of Zestra-treated participants, indicating that while generally safe, some users may experience discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, placebo-controlled, double-blind, parallel design trial of the efficacy and safety of Zestra in women with mixed desire/interest/arousal/orgasm disorders. Ferguson, DM., Hosmane, B., Heiman, JR.[2015]

Approximately 40% of women aged 18-59 report significant sexual complaints, primarily low sexual desire, with few effective pharmacological treatments available; a vacuum erection device has been FDA approved to enhance blood flow to the clitoris.

While high doses of testosterone have been shown to increase libido in postmenopausal women, the long-term safety of such treatments is uncertain, and lower doses have not demonstrated benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging therapies for female sexual dysfunction. Segraves, RT.[2019]

The clitoral vacuum suction device (CVSD) was found to be safe and effective in treating orgasmic dysfunction in women with multiple sclerosis (MS) or spinal cord injury (SCI), showing significant improvements in various sexual function measures after a 12-week trial.

While vibratory stimulation (V) also improved orgasmic function, its benefits were only observed during the treatment period, making CVSD a better option for women with multiple sexual dysfunctions or those who do not respond to V.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial of Clitoral Vacuum Suction Versus Vibratory Stimulation in Neurogenic Female Orgasmic Dysfunction. Alexander, M., Bashir, K., Alexander, C., et al.[2018]

A significant portion of heterosexually identified men in the U.S. (43.8%) have used vibrators, primarily during sexual interactions with female partners.

The high percentage of vibrator use during sexual play (94%) and intercourse (82%) suggests that incorporating vibrators into partnered relationships can be beneficial, supporting recommendations from therapists and educators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibrator use among heterosexual men varies by partnership status: results from a nationally representative study in the United States. Reece, M., Herbenick, D., Dodge, B., et al.[2015]

References

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

Psychotherapy for female sexual dysfunction: a review. [2019]

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

The Effects of a Genital Vibratory Stimulation Device on Sexual Function and Genital Sensation. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Genital vibration for sexual function and enhancement: best practice recommendations for choosing and safely using a vibrator. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Prevalence and characteristics of vibrator use by women in the United States: results from a nationally representative study. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Genital vibration for sexual function and enhancement: a review of evidence. [2020]

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

Randomized, placebo-controlled, double-blind, parallel design trial of the efficacy and safety of Zestra in women with mixed desire/interest/arousal/orgasm disorders. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Emerging therapies for female sexual dysfunction. [2019]

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

Randomized Trial of Clitoral Vacuum Suction Versus Vibratory Stimulation in Neurogenic Female Orgasmic Dysfunction. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Vibrator use among heterosexual men varies by partnership status: results from a nationally representative study in the United States. [2015]