What side effects are associated with this type of intervention?

Common treatments for erectile dysfunction include PDE5 inhibitors, vacuum erection devices, penile injections, and penile traction therapy. PDE5 inhibitors can cause headaches, flushing, nasal congestion, and visual disturbances. Vacuum erection devices may lead to bruising, pain, and numbness. Penile injections can result in pain at the injection site, prolonged erections (priapism), and fibrosis. Penile traction therapy, such as the RestoreX device, is generally safe but can cause discomfort, bruising, and temporary pain during use. It is important to discuss these potential side effects with a healthcare provider to determine the most suitable treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for erectile dysfunction, primarily focusing on pharmacological options such as phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra). These drugs enhance erectile function by increasing blood flow to the penis. In addition to pharmacological treatments, vacuum erection devices (VEDs) have also been approved. These mechanical devices create a vacuum around the penis, drawing blood into the corpora cavernosa to induce an erection. While the RestoreX penile traction device specifically aims to preserve or improve erectile function through mechanical stretching, it is not explicitly mentioned among the FDA-approved treatments for erectile dysfunction. However, VEDs share a similar mechanical approach to managing the condition.

What other types of research exist?

Promising novel alternatives to the RestoreX penile traction device for treating erectile dysfunction in 2024 include: 1) Low-intensity shockwave therapy (LiSWT), which uses acoustic waves to improve blood flow and promote tissue regeneration; 2) Platelet-rich plasma (PRP) injections, which utilize growth factors from the patient's own blood to enhance tissue repair and regeneration; 3) Stem cell therapy, which involves injecting stem cells to promote the regeneration of erectile tissue; and 4) New pharmacological agents, such as novel PDE5 inhibitors or other drugs targeting different pathways involved in erectile function. These alternatives offer various mechanisms of action and potential benefits for patients seeking to preserve or improve erectile function.

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Penile Traction Device

RestoreX Therapy for Erectile Dysfunction Post-Prostatectomy

N/A

Recruiting

Research Sponsored by Charitable Union for the Research and Education of Peyronie's Disease

Eligibility Criteria Checklist

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

Must have

>18 years old

Undergoing bilateral nerve-sparing prostatectomy

Must not have

Requiring adjuvant radiation therapy or androgen deprivation / androgen blockade post-operatively (by the time of enrollment)

Urethral complications from prostatectomy at the time of baseline visit including contrast extravasation, anastomotic dehiscence of vesicourethral anastomosis, need for re-doing of vesicourethral anastomosis intra-operatively

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the RestoreX device, which gently stretches the penis, to see if it can help men keep their erectile function after prostate surgery. The study focuses on men who already have good erectile function before surgery. The device works by improving blood flow and maintaining penile length. RestoreX is a new device with data showing improvements in penile length and erectile function with regular use in men with certain conditions.

Who is the study for?

Men over 18 with preserved erectile function facing prostatectomy can join this trial. They must be undergoing nerve-sparing surgery, not need post-op radiation or hormone therapy, and have had a stable sexual partner for the past 6 months. Men with severe ED or urethral complications from surgery are excluded.

What is being tested?

The RestoreX penile traction device's effectiveness in maintaining erectile function after robotic-assisted prostatectomy is being tested. Participants will use the device for up to 9 months, with their erectile function scored at intervals to measure any changes.

What are the potential side effects?

While specific side effects aren't listed here, penile traction devices may cause discomfort, bruising, or skin irritation. More serious side effects could include decreased sensation or injury to the penis if used improperly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18 years old.

Select...

I am having surgery to remove my prostate while preserving nerve function.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need hormone therapy or radiation after surgery.

Select...

I have complications from prostate surgery affecting my urethra.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Erectile Function Post-Prostatectomy

Secondary study objectives

Adverse events at 3 months

Adverse events at 6 months

Adverse events at 9 months

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment ArmExperimental Treatment2 Interventions

Men will begin utilizing PTT 30-60 minutes daily for 5-7 days weekly beginning 1 month post-prostatectomy until 6 months. After 6 months, they will have the option to continue to use the therapy for 3 additional months or discontinue at their discretion.

Group II: ControlActive Control1 Intervention

Men will not utilize PTT for the first 6 months post-prostatectomy. Beginning at 6 months, they may utilize PTT if they desire (open label) until 9 months post-prostatectomy.

0 / 4Eligibility criteria met

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, penile injections, and penile traction therapy. PDE5 inhibitors, such as sildenafil, work by increasing blood flow to the penis by inhibiting the enzyme phosphodiesterase type 5, which results in the relaxation of smooth muscle and vasodilation. Vacuum erection devices create a vacuum around the penis, drawing blood into the corpora cavernosa and maintaining the erection with a constriction ring. Penile injections involve injecting vasodilating agents directly into the penile tissue, which enhances blood flow and induces an erection. Penile traction therapy, like the RestoreX device, involves mechanical stretching of the penile tissue, which may help preserve or improve erectile function by promoting tissue health and preventing fibrosis. These treatments are crucial for ED patients as they offer various methods to achieve and maintain erections, thereby improving sexual function and quality of life.

Outcomes of RestoreX Penile Traction Therapy in Men With Peyronie's Disease: Results From Open Label and Follow-up Phases.Penile Rehabilitation Therapy Following Radical Prostatectomy: A Meta-Analysis.Penile rehabilitation should become the norm for radical prostatectomy patients.