What side effects are associated with this type of intervention?

Common treatments for erectile dysfunction that involve mechanical support or enhancement of blood flow include vacuum erection devices and PDE5 inhibitors such as sildenafil. Vacuum erection devices can cause side effects like penile bruising, pain, and difficulty ejaculating due to the constriction rings used. PDE5 inhibitors, including sildenafil, are generally well-tolerated but can cause headaches, flushing, indigestion, nasal congestion, dizziness, and visual disturbances. It is important to use these treatments under medical supervision to manage any potential side effects effectively.

What prior FDA approvals exist?

The FDA has approved several pharmacologic treatments for erectile dysfunction, primarily focusing on phosphodiesterase 5 (PDE5) inhibitors such as sildenafil, tadalafil, vardenafil, and avanafil. These medications work by enhancing blood flow to the penis, thereby facilitating erection. While the context does not provide specific information on FDA-approved minimally invasive erectile devices, these pharmacologic agents are the mainstay of ED treatment. Mechanical support devices, such as vacuum-assisted erection devices, are also used and do not have specific cardiovascular contraindications, making them a viable option for patients with stable cardiac disease.

What other types of research exist?

Promising novel alternatives to minimally invasive erectile devices for ED patients include: 1) Oral pharmacological treatments like sildenafil, tadalafil, and vardenafil, which have shown efficacy and safety. 2) Inflatable penile prostheses, which offer high patient satisfaction and improved designs. 3) Vibrotactile stimulation combined with visual sexual stimulation, which enhances erectile response. 4) Wearable devices designed to noninvasively support erectile function.

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Device

Wearable Device for Erectile Dysfunction

N/A

Recruiting

Led By Michael Eisenberg, MD

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 small device to help men with erectile dysfunction achieve an erection. It targets men who haven't responded to typical treatments or have erectile issues due to surgery or other health problems. The device works by providing mechanical support to keep the penis firm for sex.

Who is the study for?

This trial is for men over 18 with moderate to severe erectile dysfunction from various causes, such as post-prostate surgery or psychological issues. They must have a female partner willing to participate and be open to trying sexual intercourse.

What is being tested?

The study is testing 'Double-S', a wearable device designed as a minimally invasive solution for those experiencing erectile dysfunction, aiming to improve their condition.

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort or skin irritation due to the device's wearability and operation.

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: Double-S armExperimental Treatment1 Intervention

Participants will be asked to use the wearable penile device during intercourse.

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 Erectile Dysfunction (ED) include PDE5 inhibitors, vacuum erection devices, and minimally invasive erectile devices. PDE5 inhibitors, such as sildenafil, work by increasing vascular nitric oxide (NO) production, which enhances blood flow to the penis. Vacuum erection devices create a vacuum around the penis, drawing blood into the corpora cavernosa and using occlusive rings to maintain the erection. Minimally invasive erectile devices, like the one studied in the trial, aim to provide mechanical support or enhance blood flow with minimal intervention. Understanding these mechanisms is crucial for ED patients as it helps them and their doctors choose the most appropriate treatment based on their specific condition and preferences, potentially improving treatment outcomes and quality of life.

The management of stuttering priapism.Ischaemic priapism: A clinical review.Management of erectile dysfunction post-radical prostatectomy.