Inflatable Penile Prosthesis for Erectile Dysfunction
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?
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
Muhammet Abdurrahim Imamoglu, MD
Principal Investigator
SBU Diskapi Yildirim Beyazit Training and Research Hospital
Musab Ali Kutluhan, MD
Principal Investigator
SBU Diskapi Yildirim Beyazit Training and Research Hospital
Orhan Koca, MD
Principal Investigator
Kavacik Medistate Hospital
Metin Ishak Ozturk, MD
Principal Investigator
SBU Haydarpasa Numune Training and Research Hospital
Onder Kayigil, MD
Principal Investigator
SBU Diskapi Yildirim Beyazit Training and Research Hospital
Steven K. Wilson, MD
Principal Investigator
Department of Urology, Institute for Urologic Excellence
Paul Perito, MD
Principal Investigator
Perito Urology - Penile Implant Clinic
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are implanted with the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis
Follow-up
Participants are monitored for safety and effectiveness after implantation
Treatment Details
Interventions
- Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis
Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis is already approved in European Union, United States for the following indications:
- Erectile dysfunction
- Erectile dysfunction
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rigicon, Inc.
Lead Sponsor