177 Participants Needed

Inflatable Penile Prosthesis for Erectile Dysfunction

Recruiting at 4 trial locations
MI
OK
PP
Overseen ByPaul Perito, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis treatment for erectile dysfunction?

The Rigicon Infla10® inflatable penile prosthesis has shown high patient satisfaction and low rates of mechanical issues, similar to other three-piece inflatable penile prostheses, which are known for their effectiveness in treating erectile dysfunction. Additionally, the device has a high survival rate from revision surgeries, indicating its reliability and durability.12345

Is the Rigicon Infla10 inflatable penile prosthesis safe for humans?

The Rigicon Infla10 inflatable penile prosthesis has shown a good safety record, with less than 1% of patients needing reoperation due to issues like infection or device erosion. It has a high survival rate from revision surgery, indicating it is generally safe for human use.24567

How is the Rigicon Infla10® inflatable penile prosthesis treatment different from other erectile dysfunction treatments?

The Rigicon Infla10® is a three-piece inflatable penile prosthesis that offers high patient satisfaction and low mechanical revision rates compared to other treatments. It is unique because it involves a surgical implant with components that mimic natural erection, providing a reliable solution for erectile dysfunction.12589

Research Team

MA

Muhammet Abdurrahim Imamoglu, MD

Principal Investigator

SBU Diskapi Yildirim Beyazit Training and Research Hospital

MA

Musab Ali Kutluhan, MD

Principal Investigator

SBU Diskapi Yildirim Beyazit Training and Research Hospital

OK

Orhan Koca, MD

Principal Investigator

Kavacik Medistate Hospital

MI

Metin Ishak Ozturk, MD

Principal Investigator

SBU Haydarpasa Numune Training and Research Hospital

OK

Onder Kayigil, MD

Principal Investigator

SBU Diskapi Yildirim Beyazit Training and Research Hospital

SK

Steven K. Wilson, MD

Principal Investigator

Department of Urology, Institute for Urologic Excellence

PP

Paul Perito, MD

Principal Investigator

Perito Urology - Penile Implant Clinic

DK

Duygu Kirkik, PhD

Principal Investigator

Rigicon, Inc.

Eligibility Criteria

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.

Inclusion Criteria

I am a man aged 21 or older.
I have been diagnosed with erectile dysfunction.
Willing to complete all protocol required follow-up visits and tests
See 1 more

Exclusion Criteria

Expected life expectancy < two years
I have a bleeding disorder that may make procedures unsafe for me.
I have been diagnosed with a fibrotic condition affecting my reproductive organs.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are implanted with the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis

Procedure day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after implantation

36 months
7 visits (in-person) at 14 days, 1 month, 6 months, 12 months, 18 months, 24 months, and 36 months post-procedure

Treatment Details

Interventions

  • Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis
Trial OverviewThe 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.
Participant Groups
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.

Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Infla10 for:
  • Erectile dysfunction
🇺🇸
Approved in United States as Infla10 for:
  • Erectile dysfunction

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rigicon, Inc.

Lead Sponsor

Trials
1
Recruited
180+

Findings from Research

The three-piece inflatable penile prosthesis has been used for over 35 years and is associated with the highest patient satisfaction rates among treatments for erectile dysfunction (ED).
This device also boasts the lowest mechanical revision rates compared to other medically implanted devices, indicating its reliability and effectiveness.
Updates in inflatable penile prostheses.Henry, GD., Wilson, SK.[2007]
In a study of 535 patients who received the Rigicon Infla10 inflatable penile prosthesis over a mean follow-up of 24.2 months, only 3.5% required reoperation, indicating a high level of reliability for this device.
The survival rates from needing corrective surgery were impressive, with 96.4% at 1 year, 95.0% at 2 years, and 94.0% at 3 years, suggesting that the Rigicon Infla10 performs comparably to more established devices in the market.
Survival From Revision Surgery for New Rigicon Infla10 Three-piece Inflatable Penile Prosthesis Is Comparable to Preceding Devices.Wilson, SK., Haxhimolla, H., Kua, B., et al.[2023]
In a study of 50 men with organic impotence, the Mentor Alpha 1 inflatable penile prosthesis demonstrated a high satisfaction rate, with 98% of patients and 96% of their partners expressing satisfaction with the device.
The device showed good reliability with only a 4% complication rate, including one infection and one aneurysm, and 98% of patients indicated they would choose the procedure again, highlighting its effectiveness and safety.
Mentor Alpha 1 inflatable penile prosthesis: patient satisfaction and device reliability.Garber, BB.[2019]

References

Updates in inflatable penile prostheses. [2007]
Survival From Revision Surgery for New Rigicon Infla10 Three-piece Inflatable Penile Prosthesis Is Comparable to Preceding Devices. [2023]
Mentor Alpha 1 inflatable penile prosthesis: patient satisfaction and device reliability. [2019]
Safety outcomes of the first Rigi10™ malleable penile prostheses implanted worldwide. [2023]
Initial safety outcomes for the Rigicon Infla10® inflatable penile prosthesis. [2023]
Eleven years of experience with the inflatable penile prosthesis. [2019]
Inflatable penile prosthesis: site-specific malfunction analysis. [2007]
Retropubic Dilation With a Foley Catheter Balloon: A Novel Technique for Penile Prosthesis Reservoir Placement. [2017]
Laparascopic capsulotomy to treat autoinflation of inflatable penile prostheses. [2013]