Prostate Stimulation for Sexual Dysfunction

Overseen By Satvir Basran

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Prostatectomy, Inability to operate device, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses a special device to help men with sexual dysfunction by stimulating their prostate. The goal is to help these men achieve faster ejaculation and better erections. The Viberect handheld device is a new treatment that uses vibrations to help improve sexual function.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of prostate stimulation devices for sexual dysfunction?

The research suggests that innovative approaches, like using a strap-on dildo, can help men with erectile dysfunction (ED) by reducing the fear of erectile failure and increasing partner satisfaction. While not directly about prostate stimulators, this indicates that alternative sexual aids can be beneficial for sexual dysfunction. ^{1 2 3 4 5}

How does the prostate stimulator treatment for sexual dysfunction differ from other treatments?

The prostate stimulator is unique because it uses vibratory stimulation to enhance sexual function, which can increase sexual desire and improve erectile and ejaculatory function. Unlike traditional medical treatments, it offers a non-invasive, mechanical approach that can be used at home and may also help with pelvic floor dysfunction. ^{4 6 7 8 9}

Research Team

Michael Eisenberg, M.D.

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for men over the age of 18 who are experiencing sexual dysfunction, including erectile dysfunction, delayed ejaculation, or anorgasmia. It's not suitable for women, men under 18, those unable to operate the device, or men who have had their prostate removed.

Inclusion Criteria

I am a man over 18 with sexual dysfunction.

Exclusion Criteria

I am a male and under 18 years old.

Inability to operate the device for any reason

I have had my prostate removed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the prostate stimulation device to improve symptoms of sexual dysfunction

4 weeks

Follow-up

Participants are monitored for changes in erectile function and other symptoms after treatment

4 weeks

Treatment Details

Interventions

• Prostate stimulator

Trial Overview The study is testing a prostate stimulator device to see if it can help improve symptoms of sexual dysfunction in men. Participants will use this device as part of the treatment being studied.

Participant Groups

Group I: Prostate stimulation device arm Experimental Treatment 1 Intervention

Participants will be asked to use our prostate stimulation device.

Prostate stimulator is already approved in United States, European Union for the following indications:

Approved in United States as Prostate stimulator for:

• Sexual dysfunction
• Erectile dysfunction

Approved in European Union as Prostate massager for:

• Sexual dysfunction
• Erectile dysfunction
• Prostatitis

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

Orgasmic dysfunction, which includes issues like premature ejaculation and anorgasmia, is a significant side effect for many patients after prostate cancer treatment, impacting their quality of life.

There are effective management options available for treating orgasmic dysfunction, highlighting the need for healthcare providers to address this issue alongside erectile dysfunction to support overall sexual health for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ejaculatory and Orgasmic Dysfunction Following Prostate Cancer Therapy: Clinical Management. Green, TP., Saavedra-Belaunde, J., Wang, R.[2020]

In a study of 101 patients who underwent robot-assisted radical prostatectomy, those with high interest in sex showed that their overall satisfaction was more closely linked to urinary function and bother shortly after surgery, while later satisfaction was associated with sexual bother.

Conversely, patients with low interest in sex primarily correlated their satisfaction with urinary function and bother over time, indicating that sexual function did not significantly impact satisfaction for either group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Importance of considering interest in sex when evaluating satisfaction after robot-assisted radical prostatectomy. Kohada, Y., Ito, J., Kaiho, Y., et al.[2022]

A literature review found a strong positive correlation (r values > 0.50) between erectile function and patient satisfaction, indicating that better erectile function leads to higher satisfaction in sexual experiences.

The review included randomized, double-blind, placebo-controlled trials of phosphodiesterase type 5 inhibitors in men with erectile dysfunction, suggesting that improvements in erectile function can create a cycle of increased satisfaction and further enhancement of erectile function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlations with satisfaction measures in men treated with phosphodiesterase inhibitors for erectile dysfunction. Mulhall, JP., Kaminetsky, JC., Althof, SE., et al.[2015]

Men with prostate cancer often struggle to maintain erectile function after first-line therapy, and traditional definitions of potency may not provide an accurate picture of their sexual health.

Using a strap-on dildo as an external prosthetic can be a simple and effective alternative for managing erectile dysfunction, potentially offering benefits that surpass those of conventional medical treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restoring sexual function in prostate cancer patients: an innovative approach. Gray, RE., Klotz, LH.[2007]

Satisfaction with sex life is a key goal for patients after prostate cancer treatment, highlighting its importance as a patient-centered outcome.

Achieving sexual satisfaction involves not only preventing and treating erectile dysfunction but also leveraging the psychosocial strengths of both patients and their partners, regardless of their individual sexual function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are we targeting the right outcome for sexual health after prostate cancer treatment? Wittmann, D., Skolarus, TA., Montie, JE.[2019]

A study involving 78 men with erectile dysfunction (ED) or a combination of erectile dysfunction and premature ejaculation (ED+PE) found that combining vibrotactile stimulation with visual sexual stimulation significantly enhanced penile response compared to visual stimulation alone.

The newly developed mini-vibrator was more effective than previous models, leading to clinically significant improvements in erectile response, especially when the vibrotactile stimulation followed the erotic video.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of vibrotactile stimulation for determining sexual potency in the laboratory in men with erectile problems: methodological considerations. Rowland, DL., den Ouden, AH., Slob, AK.[2007]

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]

Approximately 44.8% of men in the U.S. have used vibrators in their sexual activities, indicating that vibrator use is quite common among this population.

Recent vibrator use is linked to better sexual health outcomes, as men who used vibrators scored higher in areas such as erectile function and sexual desire, suggesting potential benefits for sexual function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and characteristics of vibrator use by men in the United States. Reece, M., Herbenick, D., Sanders, SA., et al.[2009]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Ejaculatory and Orgasmic Dysfunction Following Prostate Cancer Therapy: Clinical Management. [2020]

2. Australia pubmed.ncbi.nlm.nih.gov

Importance of considering interest in sex when evaluating satisfaction after robot-assisted radical prostatectomy. [2022]

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

Correlations with satisfaction measures in men treated with phosphodiesterase inhibitors for erectile dysfunction. [2015]

4. Canada pubmed.ncbi.nlm.nih.gov

Restoring sexual function in prostate cancer patients: an innovative approach. [2007]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Are we targeting the right outcome for sexual health after prostate cancer treatment? [2019]

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

The use of vibrotactile stimulation for determining sexual potency in the laboratory in men with erectile problems: methodological considerations. [2007]

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

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

8. Netherlands pubmed.ncbi.nlm.nih.gov

Prevalence and characteristics of vibrator use by men in the United States. [2009]

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

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