What side effects are associated with this type of intervention?

The most common side effects of inflatable penile prostheses, such as the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis, include infection, mechanical failure, and erosion of the device through the skin. Infection rates have been reduced with the use of antibiotic-coated implants, but it remains a risk. Mechanical failure can occur, necessitating surgical revision or replacement of the device. Erosion, although rare, can lead to device exposure and requires surgical intervention. Other general side effects of erectile dysfunction treatments, such as oral medications, may include headaches, flushing, and visual disturbances.

What prior FDA approvals exist?

The FDA has approved several inflatable penile prostheses for the treatment of erectile dysfunction, similar to the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis. These devices typically consist of inflatable cylinders implanted in the penis, a fluid reservoir placed in the abdomen, and a pump located in the scrotum. When the pump is activated, fluid is transferred from the reservoir to the cylinders, creating an erection. Notable FDA-approved inflatable penile prostheses include the AMS 700™ series by Boston Scientific and the Titan® Touch by Coloplast. These devices are designed to provide a natural-feeling erection and are a viable option for men who do not respond to or cannot use pharmacological treatments like PDE-5 inhibitors (e.g., sildenafil, tadalafil).

What other types of research exist?

Promising novel alternatives to the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for erectile dysfunction patients in 2024 include: 1) Penile implants with advanced materials and designs, such as the AMS 700™ series, which offer improved durability and natural feel. 2) Shockwave therapy, which uses low-intensity sound waves to improve blood flow and promote tissue regeneration. 3) Stem cell therapy, which is being investigated for its potential to repair and regenerate erectile tissue. 4) Gene therapy, which aims to address the underlying causes of ED at the molecular level. 5) New oral medications and formulations that provide better efficacy and fewer side effects compared to existing treatments.

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Penile Prosthesis

Inflatable Penile Prosthesis for Erectile Dysfunction

N/A

Recruiting

Led By Paul Perito, MD

Research Sponsored by Rigicon, Inc.

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 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial evaluates the long-term safety and effectiveness of a surgically implanted device called Rigicon Infla 10® for men with erectile dysfunction. The device helps men achieve an erection by inflating chambers in the penis. The study will follow patients for an extended period after implantation. This type of device has been used since 1974 to treat erectile dysfunction, with long-term success and high patient satisfaction.

Who is the study for?

Men over 21 with erectile dysfunction can join this trial if they agree to use the Rigicon Infla10® prosthesis as treatment, can follow up on visits and tests, and have no allergies to device materials. Exclusions include those with anesthesia risks, previous penile surgeries, infections at surgery site or systemic infections, limited manual dexterity or mental capacity for device operation, life expectancy under two years, uncontrolled diabetes or significant other health issues.

What is being tested?

The study is testing the safety and effectiveness of the Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis in men with erectile dysfunction over a period of up to three years post-implantation. Participants will be monitored regularly following institutional standards for managing ED and any related conditions.

What are the potential side effects?

Potential side effects may include pain at implant site, infection risk increase due to surgery, mechanical failure of the prosthesis leading to additional interventions or removals. Individual experiences may vary based on personal health factors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 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

Rigidity at 12 months

Survival at 12 months

Secondary study objectives

Serious complications

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: Experimental: Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis GroupExperimental Treatment1 Intervention

Male subjects 21 years of age and older who are implanted with an Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for erectile dysfunction.

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

The most common treatments for Erectile Dysfunction (ED) include PDE5 inhibitors, vacuum erection devices, penile injections, and penile prostheses. PDE5 inhibitors, such as sildenafil, work by enhancing blood flow to the penis by inhibiting the enzyme phosphodiesterase type 5. Vacuum erection devices create an erection by using vacuum pressure to increase blood flow into the penis and occlusive rings to maintain it. Penile injections involve injecting vasodilating agents directly into the penile tissue to induce an erection. Inflatable penile prostheses, like the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis, enable an erection by manually pumping fluid into cylinders implanted in the penis, mimicking a natural erection. These treatments are crucial for ED patients as they offer various options to restore sexual function, improve quality of life, and enhance psychological well-being.

Life quality change after inflatable penile prosthesis implantation.Post-prostatectomy erectile dysfunction: contemporary approaches from a US perspective.