15 Participants Needed

Prostate Stimulation for Sexual Dysfunction

SB
Overseen BySatvir Basran
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.16789

Who Is on the Research Team?

ME

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.
See 1 more

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?
1Treatment groups
Experimental Treatment
Group I: Prostate stimulation device armExperimental Treatment1 Intervention

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

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Approved in United States as Prostate stimulator for:
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Prostate massager for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Published Research Related to This Trial

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

Citations

Ejaculatory and Orgasmic Dysfunction Following Prostate Cancer Therapy: Clinical Management. [2020]
Importance of considering interest in sex when evaluating satisfaction after robot-assisted radical prostatectomy. [2022]
Correlations with satisfaction measures in men treated with phosphodiesterase inhibitors for erectile dysfunction. [2015]
Restoring sexual function in prostate cancer patients: an innovative approach. [2007]
Are we targeting the right outcome for sexual health after prostate cancer treatment? [2019]
The use of vibrotactile stimulation for determining sexual potency in the laboratory in men with erectile problems: methodological considerations. [2007]
Genital vibration for sexual function and enhancement: a review of evidence. [2020]
Prevalence and characteristics of vibrator use by men in the United States. [2009]
Genital vibration for sexual function and enhancement: best practice recommendations for choosing and safely using a vibrator. [2020]
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