What side effects are associated with this type of intervention?

Common treatments for sexual dysfunction, including mechanical or electrical stimulation of the prostate, can have various side effects. PDE5 inhibitors, such as sildenafil and tadalafil, are generally well-tolerated but can cause headaches, flushing, dyspepsia, nasal congestion, and visual disturbances. Low-intensity extracorporeal shockwave therapy (LI-ESWT) is well-tolerated with no significant adverse effects reported. Impulse magnetic-field therapy has shown improvements in erectile function without notable adverse effects. Overall, these treatments are considered safe with minimal side effects, but individual responses may vary.

What prior FDA approvals exist?

The FDA has approved several treatments for sexual dysfunction, primarily focusing on oral phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra). These medications enhance erectile function by increasing blood flow to the penis. Additionally, vacuum erection devices, which use vacuum pressure to facilitate erections, are also FDA-approved and offer a non-invasive alternative. While the context does not provide specific FDA approvals for mechanical or electrical prostate stimulation devices, these existing treatments highlight the range of approved options for managing sexual dysfunction.

What other types of research exist?

Promising novel alternatives to prostate stimulation devices for sexual dysfunction patients in 2024 include minimally invasive laser therapies such as HoLEP (Holmium Laser Enucleation of the Prostate) and GreenLight vaporization. These treatments have shown equivalent outcomes to traditional methods like TURP (Transurethral Resection of the Prostate) and may offer benefits in preserving sexual function. Additionally, transcutaneous electrical nerve stimulation (TENS) and other neuromodulation techniques could be explored for their potential benefits in treating sexual dysfunction.

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Prostate Stimulation for Sexual Dysfunction

N/A

Recruiting

Led By Michael Eisenberg, M.D.

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and up to 1 month post-baseline

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from using the prostate stimulator may include discomfort or pain in the area of stimulation and possible aggravation of pre-existing urinary issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and up to 1 month post-baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and up to 1 month post-baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and up to 1 month post-baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

change in modified International Index of Erectile Dysfunction score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prostate stimulation device armExperimental Treatment1 Intervention

Participants will be asked to use our prostate stimulation device.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for sexual dysfunction include phosphodiesterase type 5 inhibitors (such as sildenafil), which work by increasing blood flow to the penis to facilitate erection. Mechanical or electrical stimulation devices, like the prostate stimulation device, aim to enhance sexual function by directly stimulating the prostate, potentially improving blood flow and nerve function. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options, ensuring they choose methods that align with their specific physiological needs and conditions.

A Systematic Review of the Role of Penile Rehabilitation in Prostate Cancer Patients Receiving Radiotherapy and Androgen Deprivation Therapy.The management of stuttering priapism.Management of erectile dysfunction post-radical prostatectomy.