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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a prostate stimulation device (also known as a prostate stimulator) can assist men with sexual dysfunction. Researchers seek to discover whether this device can improve symptoms such as difficulty achieving or maintaining an erection. Men who have not had their prostate removed and are experiencing sexual dysfunction might qualify for this study. Participants will use the prostate stimulation device as part of the trial. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could lead to new solutions for sexual dysfunction.

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 prior data suggests that this prostate stimulator is safe for use in men with sexual dysfunction?

Research has shown that using a prostate stimulation device might be safe and could improve sexual function. One study found that about 8.6% of users noticed better sexual function and increased ejaculate. However, 8.6% of participants reported rectal soreness, and a small number, 0.87%, experienced rectal bleeding.

These findings suggest that while the device can be beneficial, mild side effects might occur. Participants should consider these potential benefits and risks when deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for sexual dysfunction, which often include medications or psychological therapy, the prostate stimulator offers a novel approach by directly targeting the prostate. This device provides stimulation that may enhance sexual function through a new delivery method, potentially offering quicker and more direct effects. Researchers are excited about this treatment because it opens a new avenue for addressing sexual dysfunction, particularly for individuals who may not respond well to existing treatments.

What evidence suggests that this prostate stimulator is effective for sexual dysfunction?

Research has shown that vibratory stimulation, such as that in prostate stimulators, can assist with various sexual issues. For instance, it may aid in addressing erectile dysfunction and problems with arousal and orgasm. This stimulation is believed to enhance blood flow and nerve function, both crucial for sexual health. Some studies suggest that these devices might improve symptoms in men with sexual dysfunction. In this trial, participants will use a prostate stimulation device to evaluate its effectiveness. Overall, early evidence supports the potential of prostate stimulators to improve sexual function in men. ^{3 6 7 8 9}

Who Is on the Research Team?

Michael Eisenberg, M.D.

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-sexual-dysfunctions-8-2022-7e5f4

Prostate Stimulation for Sexual Dysfunction Vibratory stimulation, often associated with sex toys, has evidence supporting its use in treating various sexual dysfunctions, including erectile dysfunction, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8519170/

Application of Sex Aids in Men With Sexual Dysfunction It can be used in the treatment of sexual dysfunctions such as problems with desire, arousal, orgasm, erectile function, and pain disorders because it may help ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1507136720300407

Review Prostatic irradiation-induced sexual dysfunction For example, reported erectile dysfunction (ED) rates increase with time from treatment, with 4% ED rates at one month to 47% at 60 months post-therapy. Another ...

4. researchgate.net researchgate.net/figure/The-FERTI-CARER-vibrator-The-vibratory-stimulation-of-the-device-is-delivered-through-a_fig2_257837336

The FERTI CARE® vibrator. The vibratory stimulation of the... ... function leading to micturition disorders, anorectal complaints, and sexual dysfunction. These dysfunctions manifest among men and women with pelvic floor ...

5. research.utmb.edu research.utmb.edu/utmb-research/research-news-articles/utmb-news/2024/11/19/study-finds-erectile-dysfunction-medications-associated-with-significant-reductions-in-deaths--cardiovascular-disease--dementia

Study finds erectile dysfunction medications associated with ... Study finds erectile dysfunction medications associated with significant reductions in deaths, cardiovascular disease, dementia · Mortality: 34% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10389287/

Sexual health and treatment-related sexual dysfunction in ... This review discusses the impacts of prostate cancer treatments on sexual health in sexual and gender minorities, summarizes therapies to assist in sexual ...

7. openurologyandnephrologyjournal.com openurologyandnephrologyjournal.com/VOLUME/2/PAGE/20/FULLTEXT/

Evaluation of an At-Home-Use Prostate Massage Device ... RESULTS ; Increased sexual function and ejaculate, 10 (8.6) ; Rectal soreness/uncomfortable, 10 (8.6) ; Rectal bleeding, 1 (0.87).

8. hims.com hims.com/guides/prostate-massager

A Guide to Prostate Massagers | Good Health by Hims Prostate orgasms can be great. · A prostate massager is safe to use as long as you follow the rules. · A prostate massager probably won't fix ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7678782/

Genital vibration for sexual function and enhancement The literature indicates that vibratory stimulation has evidence-based support for the treatment of erectile dysfunction, ejaculatory dysfunction and anorgasmia ...