Vibrator Use for Female Sexual Dysfunction
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Albany Medical College
Disqualifiers: Cognitive impairment, others
No Placebo Group
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?
Is vibrator use safe for treating female sexual dysfunction?
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.34589
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
See 4 more
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.
See 3 more
Trial 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 (Behavioural Intervention)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention armExperimental Treatment2 Interventions
Group II: Control armActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Albany Medical CenterAlbany, NY
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Who Is Running the Clinical Trial?
Albany Medical CollegeLead Sponsor
References
Psychotherapy for female sexual dysfunction: a review. [2019]The increasing recognition of the significant incidence of female sexual dysfunction as well as the increasing acceptance of sex therapy as the preferred option for addressing problems in sexual functioning give rise to questions as to effectiveness of psychotherapy for female sexual dysfunction. This article presents a review of empirical studies of the treatment of female sexual dysfunction that meet minimal methodological criteria. Because of the variety and seriousness of methodological problems in the studies reviewed, guidelines for sample selection and description, research design, assessment and classification, and data analysis are provided. In addition, the 21 studies reviewed are examined for information they give about the treatment of female sexual dysfunction.
The Effects of a Genital Vibratory Stimulation Device on Sexual Function and Genital Sensation. [2021]The aim of this study was to evaluate the effectiveness of a genital vibratory stimulation device in improving sexual function in women with arousal and orgasm disorders.
Genital vibration for sexual function and enhancement: best practice recommendations for choosing and safely using a vibrator. [2020]Vibrators are an evidence-based treatment for a variety of sexual dysfunctions and sexual enhancement; however, the use of a genital vibrator lacks best practice recommendations. This aim of this article is to provide current, best practice recommendations regarding the use of vibratory stimulation for the treatment of sexual dysfunction and/or sexual or relationship enhancement. A multidisciplinary team of sexual health specialists collaborated to develop best practice recommendations based on a narrative literature review. Recommendations for the use of vibratory stimulation for the treatment of sexual dysfunction are provided, with special attention to counseling patients on choosing and safely using a vibrator. Further study is needed to determine the most effective methods to counsel patients on vibrator use and to provide evidence-based cleaning recommendations.
Prevalence and characteristics of vibrator use by women in the United States: results from a nationally representative study. [2015]Although vibrators are commonly recommended by clinicians as adjunct to treatment for female sexual dysfunction, and for sexual enhancement, little is known about their prevalence or correlates of use.
Genital vibration for sexual function and enhancement: a review of evidence. [2020]Vibration, as provided by a genital vibrator, is commonly regarded as a tool to enhance sexual pleasure and in modern day society falls under the category of a sex toy. However, the vibrator was not originally intended to be a toy, and its benefits reach far beyond that of a plaything. This article is a narrative review of the current evidence regarding the use of vibratory stimulation for the treatment of sexual dysfunction and/or sexual and relationship enhancement. The literature indicates that vibratory stimulation has evidence-based support for the treatment of erectile dysfunction, ejaculatory dysfunction and anorgasmia. Vibratory stimulation is positively correlated with increased sexual desire and overall sexual function. It has also shown benefit for sexual arousal difficulties and pelvic floor dysfunction. Though definitive evidence is lacking, genital vibration is a potential treatment for sexual dysfunction related to a wide variety of sexual health concerns in men and women.
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]Over 256 women, age 21 to 65, with acquired mixed female sexual disorders participated in a 16-week randomized, placebo-controlled, double-blind study of Zestra, a topical botanical preparation. Routine outcome instruments measured efficacy and safety. Zestra was well tolerated. The only significant safety finding was mild-to-moderate genital burning seen only in Zestra-treated subjects (14.6%). Zestra provided significant desire, arousal, and treatment satisfaction benefits for a broadly generalized group of women with sexual difficulties.
Emerging therapies for female sexual dysfunction. [2019]Epidemiological studies in the US, the UK and Sweden indicate that approximately 40% of women aged 18 - 59 have significant complaints about their sexual lives. The majority of complaints concern low sexual desire. Other common problems include difficulty reaching orgasm, insufficient lubrication and painful coitus. A vacuum erection device which increases blood flow to the clitoris has been approved by the US Food and Drug Administration. There are no pharmacological agents with approval for the treatment of female sexual dysfunction. Phosphodiesterase inhibitors and other drugs which cause genital vasocongestion in women appear to have minimal clinical efficacy. Although many of these agents increase the vasocongestive response to sexual stimulation, there is minimal correlation between subjective and objective measures of sexual arousal in women. Trials with androgens have clearly and convincingly demonstrated that supraphysiological doses of testosterone increase libido in postmenopausal women. The long-term safety of such doses is unclear. To date, no studies have shown lower doses of androgens to be beneficial. There have been minimal studies of drugs targeting the central nervous system to date. Bupropion may have a beneficial effect on orgasm attainment in women with hypoactive sexual desire disorder.
Randomized Trial of Clitoral Vacuum Suction Versus Vibratory Stimulation in Neurogenic Female Orgasmic Dysfunction. [2018]To examine the safety and efficacy of using a clitoral vacuum suction device (CVSD) versus vibratory stimulation (V) to treat orgasmic dysfunction in women with multiple sclerosis (MS) or spinal cord injury (SCI).
Vibrator use among heterosexual men varies by partnership status: results from a nationally representative study in the United States. [2015]This nationally representative study documents that vibrator use among heterosexually identified men in the United States is common, with 43.8% reporting use of a vibrator at some point in their lives, with most vibrator use by heterosexual men occurring within the context of sexual interactions with a female partner. Approximately 94% of male vibrator users reported that they had used a vibrator during sexual play with a partner, and 82% reported that they had used a vibrator during sexual intercourse. These data support the work of therapists and educators who often make recommendations for the incorporation of vibrators into partnered relationships.